[Federal Register Volume 59, Number 231 (Friday, December 2, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-29525]
Federal Register / Vol. 59, No. 231 / Friday, December 2, 1994 /
[[Page Unknown]]
[Federal Register: December 2, 1994]
VOL. 59, NO. 231
Friday, December 2, 1994
NUCLEAR REGULATORY COMMISSION
10 CFR Parts 30, 32, and 35
RIN 3150-AD69
Preparation, Transfer for Commercial Distribution, and Use of
Byproduct Material for Medical Use
AGENCY: Nuclear Regulatory Commission.
ACTION: Final rule.
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SUMMARY: The Nuclear Regulatory Commission (NRC) is amending its
regulations for the medical use of byproduct material. This action is
being taken in response to a petition for rulemaking. This final rule
is intended to provide greater flexibility by allowing properly
qualified nuclear pharmacists and authorized users who are physicians
greater discretion to prepare radioactive drugs containing byproduct
material for medical use. This final rule, while allowing research
involving human subjects using byproduct material, requires NRC
licensees who conduct such research to obtain the informed consent of
the human subjects and the prior review and approval of an
``institutional review board'' within the meaning of the Federal Policy
for the Protection of Human Subjects. This final rule also allows
medical use of radiolabeled biologics. In addition, this final rule
contains other miscellaneous and conforming amendments necessary to
clarify or update the current regulations.
EFFECTIVE DATE: January 1, 1995.
ADDRESSES: Copies of the public record, including the final regulatory
analysis and any public comments received on the proposed rule, may be
examined and copied for a fee in the Commission's Public Document Room
at 2120 L Street, NW. (Lower Level), Washington, DC.
FOR FURTHER INFORMATION CONTACT: Dr. Anthony N. Tse, Office of Nuclear
Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC
20555, telephone (301) 415-6233.
SUPPLEMENTARY INFORMATION:
I. Background
The Petition for Rulemaking
In early 1989, the American College of Nuclear Physicians (ACNP)
and the Society of Nuclear Medicine (SNM) approached the NRC staff with
concerns that the Commission's regulations failed to accommodate the
functions and responsibilities of the practice of nuclear pharmacy. At
the suggestion of the NRC staff, the ACNP and SNM submitted a petition
for rulemaking requesting the Commission to amend its regulations to
fully recognize the role of licensed nuclear pharmacists and
physicians. On September 15, 1989 (54 FR 38239), the Commission
published in the Federal Register a notice of receipt of a petition for
rulemaking for public comment (PRM-35-9).
During the development of the ACNP-SNM petition, one NRC staff
member provided substantial assistance in the preparation of the
petition. However, that individual has not participated in the NRC's
resolution of the petition or in the development of this rule. Another
NRC staff member reviewed the petition prior to its formal submittal to
the Commission and participated, to some extent, in the NRC's
resolution of the petition and in the development of the rule. The
Commission, while aware of this background, considered the petition on
its own merits.
The petition included the following requests:
A. The petitioners requested that authorized users who are
physicians (physician authorized users) be given greater flexibility
regarding the medical use of radiopharmaceuticals containing byproduct
material. Specifically, the petitioners requested that these physicians
be permitted to: (1) Use radiopharmaceuticals to treat diseases that
are not listed in the U.S. Food and Drug Administration (FDA) approved
package insert; (2) Use methods of administration of
radiopharmaceuticals that are not listed in the package insert; (3) Use
radiopharmaceuticals other than those for which the FDA has accepted an
Investigational New Drug (IND) or an approved New Drug Application
(NDA); (4) Prepare radiopharmaceuticals using radionuclide generators
and reagent kits in a manner other than in accordance with the
manufacturer's instructions; and (5) Compound radiopharmaceuticals in
accordance with State law.
B. The petitioners requested that the NRC recognize the practice of
nuclear pharmacy and the certification of nuclear pharmacists by the
Board of Pharmaceutical Specialties. Specifically, the petitioners
requested that nuclear pharmacists be permitted to: (1) Compound
radiopharmaceuticals as allowed by State or FDA regulations; (2)
Compound radiopharmaceuticals whose manufacture and distribution are
not regulated by the State or FDA; (3) Prepare radiopharmaceuticals
using radionuclide generators and reagent kits in a manner other than
in accordance with the manufacturer's instructions; (4) Produce reagent
kits; and (5) Dispense radiopharmaceuticals that are not regulated by
the FDA.
C. Additionally, the petitioners requested that the NRC: (1) Permit
categories of research using radioactive drugs that do not require an
IND, such as research approved by a Radioactive Drug Research Committee
(RDRC); (2) Permit the use of radiolabeled biologics for which the FDA
has issued a license in response to a product license application
(PLA); and (3) Clarify its regulations pertaining to specific licenses
of broad scope.
Earlier NRC Efforts
In response to the Federal Register notice that announced the
receipt of the petition, 466 comment letters were received. About 99
percent of the commenters supported and agreed with the petition. After
consideration of the public comment letters and consultation with the
FDA staff, the Commission determined that some issues should be
addressed promptly.
On August 23, 1990 (55 FR 34513), the Commission published an
Interim Final Rule to allow, for a period of 3 years, the use of
therapeutic radiopharmaceuticals for indications not listed in the
package insert and to allow departures from the manufacturer's
instructions for preparing diagnostic radiopharmaceuticals using
radionuclide generators and reagent kits. On July 22, 1993, the
Commission extended the expiration date of the Interim Final Rule from
August 23, 1993, to December 31, 1994. The action allows licensees to
continue to use byproduct material under the provisions of the Interim
Final Rule until the Commission completes this final rule.
In a parallel effort, the NRC continued to work on the remaining
issues in the ACNP-SNM petition. On August 7, 1991, the NRC conducted a
public workshop in Rosemont, Illinois, to present ``strawman'' language
on the training and experience criteria for authorized nuclear
pharmacists to representatives of the following organizations: Board of
Pharmaceutical Specialties, American Board of Science in Nuclear
Medicine, National Association of Boards of Pharmacy, Committee on
Radionuclides and Radiopharmaceuticals of the U.S. Council for Energy
Awareness, American Pharmaceutical Association, American Society of
Hospital Pharmacists, and three graduate schools of pharmacy.
Subsequently, the NRC also discussed the proposed resolution of these
issues in meetings with the FDA, the NRC's Advisory Committee on the
Medical Uses of Isotopes (ACMUI), and the Agreement States. This
rulemaking is the evolutionary result of numerous meetings with the
aforementioned groups.
NRC's Policy
In a policy statement published on February 9, 1979 (44 FR 8242),
entitled ``Regulation of the Medical Uses of Radioisotopes; Statement
of General Policy,'' the NRC stated:
1. The NRC will continue to regulate the medical uses of
radioisotopes as necessary to provide for the radiation safety of
workers and the general public.
2. The NRC will regulate the radiation safety of patients where
justified by the risk to patients and where voluntary standards, or
compliance with these standards, are inadequate.
3. The NRC will minimize intrusion into medical judgments affecting
patients and into other areas traditionally considered to be a part of
the practice of medicine.
In conformance with this policy, the Commission is eliminating
certain restrictions in the NRC regulations on the practices of
medicine and pharmacy (e.g., compounding), and is providing the
authority for research involving human subjects and the use of
radiolabeled biologics. The Commission believes that these restrictions
can be eliminated without compromising the level of protection of
public health and safety against radiological hazards. The Commission
recognizes that physicians have the primary responsibility for the
diagnosis and treatment of their patients or human research subjects
and recognizes that nuclear pharmacists have the primary responsibility
for the preparation of radioactive drugs. NRC regulations are
predicated on the assumption that properly trained and adequately
informed physicians and pharmacists will make decisions that are in the
best interest of their patients or human research subjects.
Furthermore, the pharmacological aspects of radioactive drugs,
including drug safety and efficacy, are regulated by the FDA or the
States.
II. The Proposed Rule, Public Comments, and NRC Responses
The Commission published the proposed rule in the Federal Register
on June 17, 1993 (58 FR 33396), and provided a 120-day public comment
period. About 2,500 copies of the notice of the proposed rulemaking
were mailed to all applicable NRC licensees, Agreement State and Non-
Agreement State agencies, and other interested groups.
The NRC received 284 comment letters in response to the proposed
rule. There were 280 letters in support of the proposed rule, 1 letter
in opposition to the proposed rule, and 3 letters provided comments
without specifically indicating support for or opposition to the
proposed rule. There were 182 letters from individuals working in
commercial pharmacies, 3 from pharmaceutical manufacturers, 6 from
hospitals, 7 from professional associations, 6 from universities, 5
from governmental agencies, and 75 who did not indicate their
affiliations. In terms of commenters' professions or qualifications,
the vast majority of letters were from pharmacists.
Public comments and the NRC's responses are presented below.
General comments are presented first, followed by specific comments
associated with individual sections of the rule for which comments were
received. The discussion of the changes in the proposed rule language
is presented in section III entitled ``Discussion of Final Rule Text.''
Referring to section V, entitled ``Text of Final Regulations,'' may
expedite the reader's understanding of the public comments and the
NRC's responses.
General Comments
(1) Comment. The NRC is ``straying very far'' from its mandate and
competence in regulating the medical uses of byproduct material. The
commenter appended a copy of section 104 of the Atomic Energy Act,
entitled ``Medical Therapy and Research and Development,'' as rationale
for the commenter's viewpoint.
Response. The Commission's statutory mandate in the Atomic Energy
Act of 1954, as amended, includes all uses of byproduct, source, and
special nuclear material. Specifically, section 81 of the Act
prohibits, without Commission authorization, the manufacture,
production, transfer, receipt in interstate commerce, acquisition,
ownership, possession, import, or export of byproduct material (42
U.S.C. 2111). Also, section 161 of the Act states (in part):
The Commission is authorized to establish by rule, regulation,
or order, such standards and instructions to govern the possession
and use of special nuclear material, source material, and byproduct
material as the Commission may deem necessary or desirable to
promote the common defense and security or to protect health or to
minimize danger to life or property (emphasis added).
Therefore, the Commission has broad statutory responsibility to
regulate all uses of byproduct material, including medical use.
Section 104(a) of the Atomic Energy Act states:
The Commission is authorized to issue licenses to persons
applying therefor for utilization facilities for use in medical
therapy. In issuing such licenses the Commission is directed to
permit the widest amount of effective medical therapy possible with
the amount of special nuclear material available for such purpose
and to impose the minimum amount of regulation consistent with its
obligations under this Act to promote the common defense and
security and to protect the health and safety of the public (42
U.S.C. 2134(a)) (emphasis added).
Section 104(a) on its face applies only to medical therapy
licensees for using ``utilization facilities'' (i.e., nuclear reactors)
and ``special nuclear material.'' No ``minimum regulation'' directive
governs the Commission's regulation of byproduct material. This section
does not even apply to the medical use of byproduct material, which
falls within the NRC's broad standard-setting authority in sections 81
and 161 of the Act. Even if the commenter were correct that the NRC had
a statutory obligation to minimize regulation, this rule eliminates
certain restrictions in the regulation of the medical use of byproduct
material, furthering that purpose. The Commission is, in fact, imposing
the minimum amount of regulation commensurate with the need for
protection of the public health and safety.
Regarding the NRC's competence, ``[t]he substantive area in which
an agency is deemed to be expert is determined by statute.''
Massachusetts v. United States, 856 F.2d 378, 382 (1st Cir. 1988). See
also Commonwealth of Massachusetts v. NRC, 924 F.2d 311, 324 (D.C.
Cir.), cert. denied, 112 S.Ct. 275 (1991). The Atomic Energy Act
commits to the NRC the duty of regulating the use of byproduct
materials, including radioactive drugs, to protect public health and
safety and as a matter of law the NRC is deemed ``expert'' in making
technical and policy judgements in this field.
The NRC has long experience in regulating nuclear medicine and
``[i]n recent years has increased its recruitment of personnel who have
experience and knowledge either in nuclear medicine or in radiation
therapy'' (56 FR 34104; July 25, 1991). Since the Commission's
inception, it has been accountable for the regulation of medical uses
of byproduct material. It has licensed, inspected, collected and
analyzed data in this field for many years, and has issued and
administered various forms of regulations.
Furthermore, this rulemaking is not about what dosage of a
radioactive drug should be prescribed to treat or diagnose a patient.
It is about the qualifications of individuals performing NRC-licensed
activities (e.g., authorized nuclear pharmacists) that are necessary to
protect the health and safety of patients and workers from radiological
hazards. This rule, in other words, does not intrude on medical
judgment. Moreover, the NRC has highly qualified staff and extensive
experience in determining radiation safety qualifications.
In addition, the NRC has an advisory committee (the Advisory
Committee on the Medical Uses of Isotopes or ``ACMUI''), which, since
its establishment many years ago, has advised the NRC on rulemakings
and other initiatives related to the medical uses of byproduct
material. The membership of the ACMUI includes a broad spectrum of
expertise, such as physicians (i.e., in nuclear medicine, cardiology,
and radiation oncology), medical physicists, pharmacists, medical
researchers, practicing technologists, hospital administrators, state
medical regulators, Food and Drug Administration representatives, and a
patient rights representative. The NRC also has a visiting medical
fellows program that allows selected physicians or pharmacists to work
for NRC for a period of 1 to 2 years. Both ACMUI and the visiting
medical fellows provided advice to the NRC during the development of
this rule.
(2) Comment. The NRC is attempting to duplicate regulation by other
federal, state, and national entities which already have appropriate
responsibility in the areas of medicine and pharmacy.
Response. This final rule is not duplicating regulation by other
federal or state agencies. In fact, this rule is designed to avoid
duplication of the regulations of other federal agencies (e.g., see
response to comments on Sec. 35.6). In the area of medical use of
byproduct material, the NRC and FDA signed a Memorandum of
Understanding (58 FR 47300; September 8, 1993) to coordinate existing
NRC and FDA regulatory programs. Generally speaking, FDA regulates the
manufacture and distribution of radioactive drugs and medical devices
for safety and efficacy, while the NRC regulates radiation safety
associated with the actual use of these products.
(3) Comment. The preamble to the proposed rule gives the impression
that the NRC would allow nuclear physicians and nuclear pharmacists to
use unregulated, dangerous radioactive drugs. In addition, a commenter
stated that, under State Pharmacy law, a licensed pharmacist may
delegate certain duties to non-pharmacist individuals if the pharmacist
provides ``direct supervision.'' Is it the NRC's intent to permit the
authorized nuclear pharmacist to delegate the full range of
professional duties to non-pharmacist individuals?
Response. The preamble to the proposed rule stated that a licensee
must meet the Commission's regulations regarding radiation safety of
the workers and the public, including patients, and that the licensee
is not relieved from complying with applicable FDA, other Federal, and
State requirements governing radioactive drugs. Because the FDA and
States regulate the safety and efficacy of radioactive drugs, the
licensee must also follow their regulations when using radioactive
drugs. The Commission will allow an authorized nuclear pharmacist to
delegate a full range of duties to a non-pharmacist individual provided
that the individual is properly supervised (i.e., according to
Sec. 35.25).
(4) Comment. The final rule should be effective immediately upon
publication in the Federal Register instead of being effective 6 months
after publication.
Response. The Commission agrees that licensees may not need 6
months to implement this final rule. However, with limited exceptions,
section 553(d) of the Administrative Procedure Act (APA) provides that
``[t]he required publication or service of a substantive rule shall be
made not less than 30 days before its effective date.'' The commenter
has not persuaded the NRC that good cause exists for making immediately
effective this final rule, which in part, imposes new substantive
requirements. Therefore, the effective date will be 30 days after
publication of this rule in the Federal Register.
(5) Comment. The NRC should provide a mechanism for
``grandfathering'' qualified nuclear pharmacists who are currently
working in hospital-based nuclear pharmacies, similar to the mechanism
proposed for ``grandfathering'' qualified individuals working in
commercial nuclear pharmacies.
Response. The Commission agrees with this comment because a
qualified nuclear pharmacist should be ``grandfathered'' regardless of
whether the individual is currently working in a commercial nuclear
pharmacy or a hospital-based nuclear pharmacy. Therefore, Sec. 35.981
entitled ``Training for experienced nuclear pharmacists,'' has been
added to this final rule. This section is similar to Sec. 32.72 in the
proposed rule for ``grandfathering'' qualified individuals working in
commercial nuclear pharmacies. The Commission believes that this
limited ``grandfathering'' is justified provided: (1) This individual
is currently working in a nuclear pharmacy; (2) this individual has
completed a structured educational program as specified in
Sec. 35.980(b)(1); and (3) the qualifications of this individual would
be reviewed and approved by NRC before a licensee may allow this
individual to work as an authorized nuclear pharmacist.
(6) Comment. Several commenters requested that the following items
be addressed in this rulemaking: (a) Handling of brachytherapy
radioactive sources for temporary implants related to I-125 eye
plaques, wherein the patient goes home and returns several days later
for removal of the sources; (b) Changing the person who signs the
records of sealed source leak tests, sealed source inventories, and
surveys of sealed source storage areas from the Radiation Safety
Officer to the individual who performs these tasks; and (c) Permitting
licensees to allow Radiation Safety Officers who meet certain
requirements to work without first obtaining a license amendment
(similar to the provisions proposed for authorized users and authorized
nuclear pharmacists).
Response. These items will not be addressed because they are beyond
the scope of this rulemaking.
Specific Comments
Section 32.72 Manufacture, Preparation, or Transfer for Commercial
Distribution of Radioactive Drugs Containing Byproduct Material for
Medical Use Under 10 CFR Part 35
Several commenters addressed the use of the term ``radioactive
drug.'' These comments and the NRC's responses are summarized below.
(1) Comment. One commenter stated that ``the FDA has a specific
definition which it uses for radiopharmaceuticals, and I am not aware
that it will similarly replace this word with that of radioactive
drug.'' Also, the commenter questioned whether the term ``radioactive
drug'' included radiolabeled biologics.
Response. FDA regulations define the term ``radioactive drug'' (21
CFR 310.3) but do not define the term ``radiopharmaceutical.'' As
stated in the preamble to the proposed rule, the term ``radioactive
drug'' includes a radiolabeled biologic, which is an accurate usage for
both NRC and FDA regulations.
(2) Comment. The medical use of byproduct material may be approved
by the FDA as a radioactive drug or a device. If it is approved as a
device, not a radioactive drug, would the proposed changes create
regulatory barriers in such situations?
Response. This rule does not impose any new regulatory requirements
for the use of devices containing byproduct material. Therefore, this
rule would not create regulatory barriers for the use of such devices.
Section 32.72(a)(2)
Several commenters requested clarification concerning the proposed
requirement that a nuclear pharmacy or a drug manufacturer must obtain
a Part 32 license. These comments and the NRC's responses are
summarized below.
(1) Comment. The NRC should continue to permit Part 33 or 35
medical use licensees to share a nuclear pharmacy without requiring a
Part 32 license.
Response. The Commission currently permits the nuclear pharmacy of
a Part 33 or 35 medical use licensee to distribute radioactive drugs to
a limited set of medical use licensees through a license amendment
approval on a case-by-case basis. This is the context in which such
licensees may ``share'' a nuclear pharmacy. The Commission believes
that Part 33 or 35 licensees who have been granted this authority could
continue to operate a nuclear pharmacy provided that the nuclear
pharmacy:
(i) Complies with the safety requirements specified in 10 CFR
32.72(a)(3), (a)(4), and (c);
(ii) Is operated by a medical use licensee; and
(iii) Only engages in limited distribution to a specified set of
medical use licensees but does not engage in commercial distribution.
Other Part 33 or 35 medical use licensees seeking this authority
must first apply for a license amendment and receive an authorization
for limited distribution pursuant to Part 32. The fees specified in
Category 3C of 10 CFR 170.31 and 10 CFR 171.16 are assessed for this
type of authorization. As provided in footnote 1(d)(2) of 10 CFR
170.31, there is an application fee (fee Category 3C) to add this type
of authorization. Upon issuance of the license amendment adding this
authorization, the licensee will be subject to the licensing and
inspection fees in fee Category 3C of 10 CFR 170.31 and the annual fees
in fee Category 3C of 10 CFR 171.16. These fees are in addition to any
other fee categories covered by the existing license.
However, in those cases where a small number of Part 35 licensees
wish to transfer unsealed byproduct material among themselves, the NRC
will consider granting an exemption pursuant to 10 CFR 35.19. 10 CFR
170.31 (footnote 2) specifies the fees for such exemption requests. For
existing Part 35 licensees, requests for an exemption under 10 CFR
35.19 are subject to the amendment fees specified in 10 CFR 170.31, or
fee Category 7B or 7C, as applicable.
(2) Comment. The NRC should continue to permit Part 33 licensees
who are authorized to produce radioactive drugs to be used only for
research experiments to distribute these drugs to medical use
licensees.
Response. The Commission currently permits such a Part 33 licensee
to distribute, on a limited basis, radioactive drugs to be used only
for research experiments through a license amendment approval on a
case-by-case basis. The Commission believes that Part 33 licensees who
have been granted this authority could continue to distribute these
drugs provided that the Part 33 licensee complies with safety
requirements specified in 10 CFR 32.72(a)(3), (a)(4), and (c). Other
Part 33 licensees seeking this authority must first apply for a license
amendment and receive an authorization for limited distribution
pursuant to Part 32. This type of authorization is subject to the fees
specified in fee Category 3C of 10 CFR 170.31 and 171.16. As provided
in footnote 1(d)(2) of 10 CFR 170.31, there is an application fee (fee
Category 3C) to add this type of authorization. Upon issuance of the
license amendment adding this authorization, the licensee will be
assessed the licensing and inspection fees in fee Category 3C of 10 CFR
170.31 and the annual fees in fee Category 3C of 10 CFR 171.16. These
fees are in addition to any other fee categories covered by the
existing license.
Section 32.72(a)(4).
There were numerous comments addressing the labeling requirements.
These comments and NRC's responses are summarized below.
(1) Comment. Several commenters stated that the NRC has no legal
jurisdiction over drug labeling and should not require drug labeling
because it is regulated by the FDA. Another commenter supported the
proposed labeling requirements and stated that its facility has already
included all information specified in the proposed rule.
Response. The Commission has broad authority under sections 81 and
161 of the Atomic Energy Act, as amended, including authority to
establish by rule, regulation, or order, such standards and
instructions to govern the possession and use of byproduct material.
Therefore, the Commission has jurisdiction to require labeling of
radioactive drugs containing byproduct material and is currently
requiring that specific information be included on labels.
The Commission's labeling requirements are not intended to
duplicate FDA requirements, but are intended to provide information
related to radiation safety. These labels are needed for:
(i) Hospital workers to ensure that the radioactive drug is the
correct drug and the correct dosage; and
(ii) Transport workers to identify the contents of a vial,
container, or package, and to take appropriate actions in the event of
any transportation accident.
(2) Comment. It would be very costly to have inspectors check 12
million drug labels. The commenter believes that this activity would be
entirely cost-ineffective.
Response. The modifications to current Sec. 32.72(a)(4) are
intended to clarify the existing labeling requirements, except for the
addition of ``time of assay.'' Thus, the Commission believes that
licensees will not incur significant additional cost associated with
these modifications. In terms of inspections, the NRC inspectors do not
check the label of every container or package of a radioactive drug.
They may conduct spot checks. Thus, there will not be a significant
cost for NRC inspectors either.
(3) Comment. The syringe label should not be limited to the
clinical procedure. On the other hand, it is unnecessary to require
that the label, or the leaflet or brochure that accompanies the
radioactive drug, contain all of the statements specified in the
proposed rule.
Response. The regulatory text in this section states: ``In
addition, the label for the syringe or syringe radiation shield must
also contain the clinical procedure to be performed or the patient's or
the human research subject's name.'' Thus, the clinical procedure is an
additional item but not the only item on the label.
Regarding the statements that must be included in the leaflet or
brochure, the Commission believes these statements are necessary
because they serve as warnings to individuals who are not authorized to
use the byproduct material. However, the statement that ``other
regulatory approvals may be required'' has been deleted because this
concern is already covered by 10 CFR 35.7.
(4) Comment. It is unclear as to the legal origin of the statement
that ``NRC's labeling requirements are independent of requirements of
the U.S. Food and Drug Administration (FDA).''
Response. This comment quotes the last sentence of Sec. 32.72(a)(4)
of the proposed rule, stating that: ``NRC's labeling requirements are
independent of requirements of the U.S. Food and Drug Administration
(FDA).'' This comment appears to question the NRC's statutory authority
for the quoted statement. As previously stated in response to comment 1
on Sec. 32.72(a)(4), the NRC's statutory authority to impose
requirements with respect to the labeling of radioactive drugs
containing byproduct material derives from its authority under the
Atomic Energy Act (primarily sections 81 and 161b) to regulate
byproduct material. The quoted sentence makes it clear that NRC's
labeling requirements are separate from the labeling requirements of
FDA.
Section 32.72(b)
There were several comments concerning this paragraph. These
comments and the NRC's responses are discussed below.
(1) Comment. The phrase ``within 30 days of the date'' used in the
proposed Sec. 32.72(b)(3) is confusing and should be replaced with ``no
later than 30 days after the date.''
Response. The Commission agrees with the comment. The final rule
text has been modified accordingly.
(2) Comment. In the preamble of the proposed rule discussing
proposed Sec. 32.72(b)(3), the use of the phrase ``individual's
character'' in determining whether the individual should be approved as
an authorized nuclear pharmacist appears inappropriate.
Response. The NRC disagrees with this comment. Under sections 182
and 183 of the Atomic Energy Act, the Commission has broad authority
over the scope of license applications and the terms of licenses.
Section 182(a) includes the authority to require, by rule or
regulation, such information as the Commission determines necessary to
decide, among other things, the technical and other qualifications of
the applicant as the Commission may deem appropriate, as well as the
applicant's character. Therefore, in determining whether to grant a
license or license amendment, or approve an individual to perform
licensed activities, the NRC can consider the past performance and
character (which may include activities involving improper or illegal
practices) of the license applicant, the licensee, or the individual
who is to perform licensed activities. An individual occupying the
position of a physician authorized user or authorized nuclear
pharmacist has the potential to affect the public health and safety.
Accordingly, it would be appropriate for the NRC to consider
information relating to that individual's ``character.''
(3) Comment. If an authorized nuclear pharmacist decides not to
seek recertification as a Board Certified Nuclear Pharmacist, would the
individual lose the authorized nuclear pharmacist status?
Response. No. If an individual gained authorized nuclear pharmacist
status based on board certification and decided not to seek
recertification, this individual may continue to work as an authorized
nuclear pharmacist provided this individual continues to be identified
as an authorized nuclear pharmacist on a Commission or Agreement State
license or on a permit issued by a Commission or Agreement State
licensee of broad scope.
(4) Comment. Would the scope of ``grandfathering'' extend beyond
the initial transition period?
Response. The Commission believes it is not necessary to limit the
``grandfathering'' provision to a definite period after the effective
date of this final rule. Therefore, there is no time limit for the
``grandfathering'' provision.
Section 32.72(c)
There were several comments concerning instrumentation. These
comments and the NRC's responses are discussed below.
(1) Comment. The proposed requirements for linearity and geometry
tests are not consistent with methods of assaying alpha or beta
emitters, such as liquid scintillation counting.
Response. The regulatory text includes the phrase ``as appropriate
for the use of the instrument.'' Therefore, if linearity or geometry
tests are not appropriate for an instrument, the tests are not
required.
(2) Comment. The regulation does not require medical use licensees
to measure the activity of a unit dosage of an alpha- or a beta-
emitting radionuclide. This provision should also apply to commercial
nuclear pharmacies.
Response. Section 35.52(a) will exempt a medical use licensee from
measuring the alpha- or beta-activity of a unit dosage, if the licensee
obtains that unit dosage from a commercial nuclear pharmacy. This
exemption is acceptable because Sec. 32.72(c) will require the
commercial nuclear pharmacy to measure that activity before dispensing
the radioactive drug. Commercial nuclear pharmacies would be required
to measure the alpha- or beta-activity of a unit dosage because,
otherwise, it might not be measured by anyone. Therefore, this
provision cannot be applied to commercial nuclear pharmacies.
Authorized Nuclear Pharmacist
There were several comments concerning this definition. These
comments and the NRC's responses are summarized below.
(1) Comment. This definition uses the phrase ``a permit issued by a
Commission or Agreement State specific licensee of broad scope.'' Is
there a standard format for this permit?
Response. The Commission does not require licensees of broad scope
to use a standard format for a permit. The format for this permit may
vary from one licensee to another.
(2) Comment. The word ``or'' should be inserted between the first
and second paragraphs of this definition.
Response. It is an acceptable regulatory drafting convention that
for a sentence with multiple independent conditions, only one ``or'' is
necessary between the last condition and the previous condition to
indicate that satisfying any one of the conditions is acceptable.
Because this definition has three independent conditions, an ``or''
between the first and the second condition is not necessary.
Authorized User
Comment. There were several comments concerning the use of the
phrase ``individual's character'' in the preamble of the proposed rule.
The commenters stated that the use of the phrase ``individual's
character'' appears inappropriate in considering whether the individual
should be approved as an authorized user.
Response. For the same reasons as set forth in response to comment
(2) of Sec. 32.72(b), the Commission disagrees with the comment.
Medical Use
There were several comments concerning the addition of human
research subjects in the definition of medical use. These comments and
the NRC's responses are summarized below.
(1) Comment. By including human research subjects under ``medical
care,'' it is implied that a physician may be allowed to deliver any
radiation dose to a human research subject if the physician can
convince the local IRB that the dose is warranted. Also, the concept of
implying that human research subjects can be considered as patients may
cause difficulty because there are separate laws and considerations for
each group.
Response. The definition under discussion is ``medical use,'' not
``medical care.'' The term ``medical use'' is specifically defined for
the purpose of identifying a class of uses involving byproduct material
that is regulated by the Commission. By using the term ``patients or
human research subjects'' in connection with a requirement, the
Commission states that the requirement applies to both patients and
human research subjects. The Commission does not intend to imply that a
human research subject can be considered as a patient, nor does the
Commission intend to imply that a physician may deliver any radiation
dose to a human research subject, without appropriate approval.
The Commission recognizes that there are separate medical or
pharmacy laws and considerations governing human research subjects and
patients. However, the Commission has determined that the radiation
safety requirements in its regulations that are designed to protect
patients from radiological hazards are equally applicable to human
research subjects.
(2) Comment. There could be some difficulty when applying the
quality management program to human research subjects. Also, annual
review of human use studies is redundant of FDA regulations.
Response. The quality management program (QMP) applies only to
research procedures using quantities of byproduct material specified in
Sec. 35.32(a)(1). However, because most research procedures use
quantities of byproduct material that are less than those specified in
Sec. 35.32, the QMP would not be required for these research
procedures.
The review specified in Sec. 35.32(b) applies only to human
research procedures for which written directives are required. The
review includes evaluation of a representative sample of
administrations, recordable events, and misadministrations, to verify
compliance with the QMP. These evaluations are specifically related to
the requirements in the Commissions's regulations, which are not
redundant of FDA regulations.
Section 35.6 Provisions for Research Involving Human Subjects
In the preamble of the proposed rule, the Commission solicited
public comment on the number and type of research activities which
would not be funded by another Federal agency which has adopted the
Federal Policy and which would require a license amendment under the
proposed rule. No comments on the number and type of such research
activities were received.
Also, the Commission solicited public comment on whether it should
broaden or narrow its focus to require compliance with all or none of
the provisions of the Federal Policy or equivalent license conditions.
The Commission stated that in making these comments, consideration
should be given to the fact that all radiation safety provisions of 10
CFR part 35 would be made applicable to research involving human
subjects. Several comments were received related to this topic. These
comments and the NRC's responses are summarized below.
(1) Comment. Omit all regulation of human research with radioactive
material because the FDA handles this very nicely.
Response. The Commission cannot omit all such regulation because it
has the responsibility for ensuring adequate protection of public
health and safety related to the use of byproduct material, including
uses involving human research subjects.
In view of the fact that this final rule would specifically permit,
in certain circumstances, NRC licensees to use radioactive drugs
containing byproduct material for research involving human subjects,
the Commission has the responsibility to address the protection of the
rights of those human subjects. At a minimum, this final rule requires
NRC licensees who conduct such research to obtain the informed consent
of the human research subjects and the prior review and approval of an
IRB, within the meaning of the Federal Policy for the Protection of
Human Subjects. These requirements apply whether or not the research is
conducted, funded, supported, or regulated by another federal agency
which has implemented this Federal Policy or is approved by the
amendment of an NRC license. However, NRC licensees whose human
research is covered by the Federal Policy as adopted by another federal
agency, may conduct such research without prior NRC approval. In this
way, the provisions of this rule are designed to avoid duplication of
the regulations of other federal agencies which have adopted the
Federal Policy, including the FDA.
(2) Comment. The NRC should take steps to ensure that all
provisions of the Federal Policy for the Protection of Human Subjects
are met.
Response. The basic safety objectives and ethical principles of the
Federal Policy will be met by requiring licensees to obtain the
informed consent of the human research subjects and prior approval by
an IRB. However, some provisions of the Federal Policy are not directly
applicable to the Commission's oversight of its licensees, such as the
``Use of Federal Funds,'' ``Evaluations of Proposals for Research to be
Conducted or Supported by a Federal Department or Agency,'' and ``Early
Termination of Research Support.'' Therefore, NRC does not need to take
steps to ensure that all provisions are met.
On the other hand, the proposed rule did not explicitly state that
the required informed consent and IRB approval must be in accordance
with the provisions of the Federal Policy for the Protection of Human
Subjects. Therefore, a phrase ``in accordance with the meaning of these
terms as defined and described in the Federal Policy for the Protection
of Human Subjects'' has been added to the text of the final rule to
clarify this point.
There were comments concerning the addition of ``human research
subjects'' in the definition of ``medical use'' and the broadening of
the quality management program to include human research subjects.
These comments and NRC's responses are summarized in the discussion of
the definition of ``medical use'' under Sec. 35.2.
Section 35.14 Notification
Comment. Several commenters stated that the phrase ``within 30 days
of the date'' in the proposed Sec. 32.72(b)(3) may be misinterpreted
and suggested that a new phrase ``no later than 30 days after the
date'' should be used.
Response. See response to comment (1) of section 32.72(b).
Section 35.22 Radiation Safety Committee
Comment. There were two comments concerning this section. One
commenter agreed with the proposed change. The other commenter stated
that the proposed change was not warranted because the Radiation Safety
Committees (RSC) are overburdened by other duties.
Response. The Commission believes that it is important for the RSC
to review the training and experience of authorized users and
authorized nuclear pharmacists and to approve or disapprove any such
individuals because this review and the approval or disapproval by RSC
is a key factor in the program to ensure radiation safety. Furthermore,
existing regulations already require the RSC to perform such review and
approval or disapproval of authorized users, Radiation Safety Officers,
and teletherapy physicists. By adding authorized nuclear pharmacists to
the review and approval or disapproval process of the RSC, the
Commission does not believe that a significant burden will be added to
the RSC's responsibilities because it is expected that a relatively
small number of authorized nuclear pharmacists will be included in Part
35 licenses.
Section 35.25 Supervision
Comment. Several commenters stated that this section should not be
so restrictive and that instructions to workers can only be provided by
the supervising individuals. These commenters suggested that the
provision for instructing workers may be delegated to other qualified
individuals. Similarly, they suggested that periodic review of the work
of the supervised individuals may also be delegated to other qualified
individuals.
Response. The Commission agrees that the workers may be instructed
by the licensee, the supervising individuals, or other qualified
individuals as long as the instructors are knowledgeable about the
subject areas. The regulatory text has been revised to indicate that
although the licensee may delegate these tasks to other qualified
individuals, the licensee retains the responsibility for instructing
workers.
However, the requirement for periodically reviewing the work of
supervised individuals remains with the supervising authorized nuclear
pharmacist or physician authorized user. The Commission believes that
the supervising individual is in a better position to review the work
than another individual.
Section 35.27 Visiting authorized user.
Comment. One commenter suggested that this section should be
retained. The commenter stated that the paperwork associated with the
proposed notification (Sec. 35.14) would be unduly burdensome for
temporary authorized users who provide coverage during another
authorized user's vacation or sickness.
Response. The Commission disagrees with the commenter. When
allowing a temporary authorized user to work, the licensee does not
need to notify the NRC each time that the individual provides coverage
during another authorized user's vacation or sickness. Under the
notification requirement (Sec. 35.14), the licensee needs to notify the
NRC no later than 30 days after the date the licensee permits the
individual to work as a temporary authorized user. The next
notification is when that individual permanently discontinues as a
temporary authorized user. A notification is not required during each
period of coverage between the beginning and the termination of the
service of the temporary authorized user. This notification procedure
also applies to a temporary authorized nuclear pharmacist. Thus, this
section has been removed.
Section 35.50 Possession, Use, Calibration, and Checks of Dose
Calibrators.
Several comments were received related to this section. These
comments and NRC's responses are summarized below.
(1) Comment. The proposed phrase ``over the range of its use
between the highest dosage that will be administered to a patient or
human research subject and 1.1 megabecquerels (30 microcuries)'' should
be clarified. ``Over the range of its use'' could mean between the
highest and lowest dosages that will be administered; the lowest dosage
may not be 1.1 megabecquerels.
Response. The Commission agrees with the comment. The final
amendment will be modified to delete the phrase ``over the range of its
use.''
(2) Comment. Linearity tests for a dose calibrator should cover the
range from the highest patient dosage to the lowest patient dosage that
will be administered by a licensee. The lowest dosage could be in
millicurie quantities for many licensees. Thus, it is not necessary to
test linearity to 1.1 megabecquerels (30 microcuries).
Response. The intent of changing the lower limit of the linearity
tests from 10 microcuries to 30 microcuries is to conform with the
requirements of the Quality Management Program (Sec. 35.32) and to
relieve a minor burden for measuring activities between 10 and 30
microcuries without reducing radiation safety. To go beyond this by
changing this limit to the lowest patient dosage would have
ramifications on the constancy checks, accuracy tests, and
recordkeeping requirements (i.e., Secs. 35.50(b)(1), (b)(2), and
(b)(3); and 35.53(a), (b), and (c)(3)). Therefore, deleting this
specific lower limit is beyond the scope of this rulemaking.
(3) Comment. In expressing the units in both English units and SI
units, English units should be first, followed by SI units in
parentheses. Also, is there any scientific rationale for the precision
implied by 1.1 mBq, instead of using 1 mBq?
Response. The Commission published a policy statement entitled
``Conversion to the Metric System'' (57 FR 46202; October 7, 1992).
This policy statement specifies that the first unit will be in the SI
unit with the English unit shown in brackets. In terms of significant
digits, the implied uncertainty for 30 microcuries is somewhere between
29 and 31 microcuries and for 1.1 mBq is somewhere between 1.0 and 1.2
mBq. If 1 mBq is used, the implied precision would be less. Therefore,
1.1 mBq has been retained in the final rule.
Section 35.52 Possession, Use, Calibration, and Checks of
instrumentation to measure dosages of alpha- or beta-emitting
radionuclides.
There were several comments concerning this section. These comments
and the NRC's responses are discussed below.
(1) Comment. The proposed requirements for linearity and geometry
tests are not consistent with methods of assaying alpha or beta
emitters, such as liquid scintillation counting.
Response. The regulatory text includes the phrase ``as appropriate
for the use of the instrument.'' Therefore, if linearity or geometry
tests are not appropriate for an instrument, the tests are not
required.
(2) Comment. Does the term ``unit dosage'' include a vial that
contains multiple dosages?
Response. A unit dosage can be either a pre-filled syringe or a
vial that contains a prescribed dosage for a patient or a human
research subject. Thus, a vial containing multiple dosages is not a
unit dosage.
(3) Comment. In some cases, it may not be practical to order an
exact unit dosage before the administration to a patient or human
research subject. For example, the size of a brain cyst is determined
during surgery and a precise dosage cannot be prescribed before the
operation.
Response. In this example, an estimated unit dosage must first be
ordered from the nuclear pharmacy. After the physician authorized user
determines the precise dosage needed for the individual, the licensee
may use either volume or weight to draw the precise dosage from the
vial. The use of volume or weight for drawing a smaller dosage from a
vial containing an estimated dosage is acceptable because that vial
contains only the estimated dosage for one individual. Thus, even if an
error is made, the maximum error would be limited to the estimated
dosage.
(4) Comment. When drawing a dosage from a vial containing multiple
dosages, a licensee should be allowed to determine the dosage by using
volume and a measurement relative to some standard.
Response. Relative measurement of the alpha- or beta-activity of a
radioactive drug could be inaccurate for a variety of reasons,
including inconsistent placement of the vial in the instrument's
chamber. Without specific details of the procedure for this relative
measurement, the accuracy of the measurement is unknown. Therefore, the
proposed method of using volume and a measurement relative to some
standard cannot be generically accepted.
However, if a medical use licensee would like to propose a specific
set of procedures for a relative measurement of a particular isotope
that would provide acceptable accuracy, the licensee may apply for a
license amendment on a case-by-case basis.
Section 35.53 Measurement of Dosages of Unsealed Byproduct Material
for Medical Use
There were some comments concerning measurements of dosages. These
comments and NRC's responses have been discussed under Sec. 35.52.
Section 35.100 Use of Unsealed Byproduct Material for Uptake,
Dilution, and Excretion
There were several comments concerning this section. These comments
and the NRC's responses are discussed below.
(1) Comment. The NRC should continue to permit medical use
licensees to share a nuclear pharmacy without requiring a Part 32
license.
Response. See response to comment (1) of section 32.72(a)(2).
(2) Comment. Section 35.100 should be modified to allow a medical
use licensee to obtain a radioactive drug only for research purposes
from those Part 33 licensees who are authorized to manufacture and
distribute radioactive drugs to be used only for research experiments.
Response. The Commission currently permits a Part 33 licensee to
distribute, on a limited basis, radioactive drugs to be used only for
research experiments through license amendment approvals on a case-by-
case basis. As discussed in the response to comments on 10 CFR
32.72(a)(2), Part 33 licensees seeking this authority must first obtain
a license amendment and receive an authorization for limited
distribution pursuant to Part 32. Therefore, it is not necessary to
modify Sec. 35.100 because it will allow medical use licensees to
receive radioactive drugs from a Part 33 licensee authorized for
limited distribution.
Section 35.910 Training for Uptake, Dilution, and Excretion Studies
Comment. One commenter stated that the proposed amendment to this
section would impose severe restrictions on basic human research. The
commenter further stated that researchers who desire approval to
administer radioisotopes for one or two basic studies in humans and who
are not preparing to become nuclear medicine physicians, will not meet
these strict criteria.
Response. Under the NRC's existing regulatory framework,
administering byproduct material to a patient or a human research
subject must be done by a physician authorized user or by an individual
under the supervision of a physician authorized user. The use of the
term ``patient or human research subject'' in this section is to
clarify that, if a researcher intends to conduct basic studies using
human subjects involving byproduct material, it is necessary to have a
physician authorized user provide supervision so that the researcher
may administer byproduct material to human research subjects. This is
an existing regulatory position and it has not been changed by this
rulemaking.
Section 35.930 Training for Therapeutic Use of Unsealed Byproduct
Material
Comment. One commenter stated that the certification by the
American Osteopathic Board of Radiology (AOBR) should be recognized in
all applicable sections in 10 CFR Part 35. Under the existing
regulations, the Commission has recognized AOBR in Secs. 35.910,
35.920, 35.940, 35.950, and 35.960, but not in Sec. 35.300.
Response. Following receipt of this comment, the Commission
requested additional information from AOBR concerning training and
certification criteria for therapeutic use of unsealed byproduct
material. After reviewing supporting documents provided by the AOBR,
the Commission has determined that the certification of AOBR is
equivalent to the certification of American Board of Radiology (ABR).
Therefore, recognition of certification by AOBR has been added in
Sec. 35.930 of this final rule for certification granted after 1984
because all candidates certified by AOBR since 1984 will meet the NRC's
training requirements.
Section 35.972 Recentness of Training
Comment. There were several comments concerning whether the
recentness of training should be 5 years as in the existing
regulations, or 7 years as in the proposed rule. Some commenters
favored 5 years and stated that the clinical practice changes rapidly,
thus, 5 years is more appropriate. Other commenters supported 7 years
and stated that 5 years would be burdensome and would not ensure
superior training.
Response. The training required in Part 35 concerns radiation
safety principles and practices for the protection of public health and
safety. These radiation safety principles and practices are not
expected to change rapidly with time. Therefore, the Commission is
adopting 7 years because this will not reduce the level of radiation
protection provided to workers and the public but will reduce the
regulatory burden imposed on licensees.
Section 35.980 Training for Authorized Nuclear Pharmacist
There were several comments pertaining to this section. These
comments and the NRC's responses are summarized below.
(1) Comment. The requirement for a preceptor statement is
unnecessary and is irrelevant to the mission of the NRC. Many fully
qualified nuclear pharmacists would be excluded from being an
authorized nuclear pharmacist by this administrative requirement.
Response. The written certification from a preceptor is a necessary
part of the training and experience criteria. Even though an individual
has completed the required 700 hours of the structured educational
program, it is still uncertain as to whether this individual is capable
of independently operating a nuclear pharmacy. The preceptor's
statement is needed to ensure that this individual has achieved the
competency to do so.
With respect to a nuclear pharmacist who is currently qualified to
be an authorized nuclear pharmacist, a new section (Sec. 35.981) has
been added to address this issue.
(2) Comment. It appears that the proposed rule is leaning towards
board certification as the only available avenue open to a nuclear
pharmacist desiring to be recognized as an authorized nuclear
pharmacist in the near future.
Response. There are other available avenues for a qualified
individual to be recognized as an authorized nuclear pharmacist. Other
avenues include: (i) Meeting the training criteria and obtaining a
preceptor statement from an authorized nuclear pharmacist; or (ii)
Meeting the ``grandfathering'' provisions as specified in Sec. 35.981
of this final rule.
(3) Comment. Whether an individual is qualified as an authorized
nuclear pharmacist should be based on education and training, not just
based on BPS certification.
Response. The Commission agrees that qualification as an authorized
nuclear pharmacist should be based on training and experience. This
final rule provides several ways, including BPS certification, to
achieve authorized nuclear pharmacist status, all of which include a
minimum level of training and experience. The various ways to achieve
this status are provided in Secs. 35.980 and 35.981.
(4) Comment. It is imperative that training programs be monitored
by appropriate independent oversight processes (e.g., American Council
on Pharmaceutical Education in the case of pharmacy).
Response. The Commission agrees that it could be useful for a
training program to be monitored by an independent oversight group. In
addition, the Commission encourages voluntary oversight by an
independent group such as a professional association. However, given
the oversight roles of the preceptor and the Radiation Safety
Committee, the Commission does not see a need to incorporate such a
requirement.
(5) Comment. If an authorized nuclear pharmacist decides not to
seek recertification as a Board Certified Nuclear Pharmacist, would the
individual lose the authorized nuclear pharmacist status?
Response. See response to comment (3) of Sec. 32.72(b).
(6) Comment. It appears that the NRC desires to make ``authorized
nuclear pharmacist'' status available only to those pharmacists who are
engaged in active clinical practice settings. This status should be
also available to qualified nuclear pharmacists working in facilities
other than clinical practice settings, such as in the research
laboratories or academic settings.
Response. An authorized nuclear pharmacist who meets the training
requirements as specified in Sec. 35.980 should be competent to
independently operate a nuclear pharmacy regardless of the setting.
When there is a need for an authorized nuclear pharmacist outside the
clinical setting, qualified individuals in research laboratories or
academic settings may also be designated as authorized nuclear
pharmacists.
(7) Comment. Authorized nuclear pharmacist status should be
available to those individuals who have practiced radiopharmacy for a
long time but who are not licensed pharmacists.
Response. The Commission believes that an individual should not
practice pharmacy unless this individual is licensed as a pharmacist by
a State. Thus, an authorized nuclear pharmacist must be a licensed
pharmacist as required by Secs. 35.980 and 35.981. However, an
experienced individual (e.g., a nuclear chemist) may continue to work
in a nuclear pharmacy under the supervision of an authorized nuclear
pharmacist or a physician authorized user.
(8) Comment. The Florida State Board of Pharmacy issues nuclear
pharmacists a separate license based on a review of the individual's
qualification by its Nuclear Pharmacy Committee. Additionally, it
requires a mandatory 12-hours per annum of continuing education in a
specific range of topic areas pertinent to nuclear pharmacy practice.
With this type of licensing review process already in place, how would
the NRC consider applying this towards its ``limited grandfathering''
process for granting ``authorized nuclear pharmacist'' status to
Florida nuclear pharmacists? Would the Commission consider this
established Florida process for pharmacists as carrying sufficient
weight which might serve as a third alternative to its proposed
language in 10 CFR 35.980?
Response. Section 35.980 specifies that a pharmacist could be
qualified as an authorized nuclear pharmacist in two ways: (i) Through
BPS certification; or (ii) through a structured educational program and
a preceptor's statement. Because qualification as an authorized nuclear
pharmacist depends primarily on training and experience, if Florida
licensed nuclear pharmacists currently meet either (i) or (ii), they
could qualify as authorized nuclear pharmacists. If they do not meet
either (i) or (ii), they would need either more training or experience,
or a preceptor's statement to qualify. Therefore, there is no benefit
to adding a third alternative to 10 CFR 35.980.
For ``grandfathering'' an experienced nuclear pharmacist, a new
section (Sec. 35.981) has been added to the final rule. This section
specifies that an experienced pharmacist will be given authorized
nuclear pharmacist status if the individual:
(i) Is a licensed pharmacist,
(ii) Is currently working in a nuclear pharmacy, and
(iii) Has completed a structured educational program as specified
in Sec. 35.980(b)(1).
A Florida licensed nuclear pharmacist who is currently working in a
nuclear pharmacy could satisfy the first two criteria. However, the
comment letter did not provide any information regarding whether this
individual meets the third criterion. Therefore, such a nuclear
pharmacist could qualify as an authorized nuclear pharmacist if that
individual has completed a structured educational program that equals
or exceeds the requirements of Sec. 35.980(b)(1).
Section 35.981 Training for Experienced Nuclear Pharmacists
Comment. This section was not included in the proposed rule, but
has been added to the final rule in response to numerous comments. The
comments suggested that the NRC should provide a mechanism for
``grandfathering'' qualified nuclear pharmacists who are currently
working in hospital-based nuclear pharmacies, similar to the mechanism
proposed for ``grandfathering'' qualified individuals who are currently
working in commercial nuclear pharmacies.
Response. The Commission agrees with these comments because the
``grandfathering'' provisions should apply regardless of whether a
qualified nuclear pharmacist is currently working in a commercial
nuclear pharmacy or a hospital-based nuclear pharmacy. Therefore, this
section has been added to the final rule.
III. Discussion of Final Rule Text
This section discusses those provisions of the final rule in which
the proposed rule language has been modified. These modifications are
either based on public comments or the Commission's identified need to
modify or clarify the rule language. Provisions in which the final rule
language remains the same as the proposed rule language will not be
discussed in this section. Referring to section V entitled ``Text of
Final Regulations'' may expedite the reader's understanding of this
discussion.
Section 32.72 Manufacture, Preparation, or Transfer for Commercial
Distribution of Radioactive Drugs Containing Byproduct Material for
Medical Use Under 10 CFR Part 35
Section 32.72(a)(4)
This paragraph contains one modification of the proposed rule
language. The phrase ``one label is acceptable to NRC provided that it
contains all of the information which NRC requires'' has been added at
the end of the last sentence of this paragraph. This phrase has been
added to clarify that this rule allows licensees to use one label if
that label contains all the information specified in this section.
Section 32.72(b)
The proposed rule language has been modified to clarify the intent
of this section. These modifications are discussed below.
(1) The phrase ``a licensee described by paragraph (a)(2)(iii) or
(iv) of this section'' has been moved from proposed Sec. 32.72(b)(1) to
the introductory phrase of Sec. 32.72(b) to clarify that this phrase
applies throughout paragraph (b).
(2) The final rule text of Sec. 32.72(b)(1) is essentially the same
as the proposed (b)(1) except that the reference to the definition of
``authorized nuclear pharmacist'' in Part 35 has been moved to
paragraph (b)(2).
(3) A new Sec. 35.72(b)(2) has been added to the final rule to make
clear that there are three different ways that an individual may
qualify as an authorized nuclear pharmacist.
(4) A new Sec. 35.72(b)(3) has been added to the final rule to make
clear that the actions authorized in Sec. 32.72(b)(1) and (2) are
permitted in spite of more restrictive language in existing license
conditions and to avoid the need for many license amendments in order
to implement the Commission's intentions.
(5) The proposed Sec. 32.72(b)(2), which provided criteria for
``grandfathering'' qualified Part 32 ``authorized users,'' has been
redesignated as Sec. 32.72(b)(4). Also, the proposed rule specified
that a pharmacist may be ``grandfathered'' if the individual is
identified on a Commission license as an ``authorized user'' on or
before the ``effective date'' of the rule; this cutoff date has been
changed to the publication date of the final rule. This change is
needed because the Commission believes that ``grandfathering'' is only
appropriate for those qualified nuclear pharmacists who are
``authorized users'' on or before the publication date of this final
rule.
(6) The proposed Sec. 32.72(b)(3), which requires licensees to
provide certain documents, has been redesignated as Sec. 32.72(b)(5).
The final rule text in this paragraph has been modified to include
several editorial changes, including:
(i) Replacing the phrase ``the individual's board certification,
the license, or the permit'' by the phrase ``each individual's
certification by the Board of Pharmaceutical Specialties, the
Commission or Agreement State license, or the permit issued by a
licensee of broad scope'';
(ii) Replacing the phrase ``within 30 days of the date'' by the
phrase ``no later than 30 days after the date''; and
(iii) Adding ``pursuant to paragraphs (b)(2)(i) or (b)(2)(iii)'' to
indicate that a notification is not required by paragraph (b)(2)(ii)
because a license amendment is required.
Section 35.2 Definitions
Authorized nuclear pharmacist. During the public comment period,
the Commission became aware that the word ``currently'' is unnecessary
in the proposed phrase ``Authorized nuclear pharmacist means a
pharmacist who is: (1) Currently board certified as a nuclear
pharmacist by ______.'' Therefore, the word, ``currently,'' has been
removed in the final rule.
Misadministration. During the public comment period, the Commission
became aware of the need to clarify paragraph (4)(iii) of this
definition. The existing rule language, ``When the calculated weekly
administered dose is 30 percent greater than the weekly prescribed
dose,'' if interpreted literally, means that a misadministration has
occurred only when the calculated weekly administered dose is exactly
30 percent greater than the weekly prescribed dose. The Commission
intended for this definition to cover incidents in which there is a
difference of 30 percent or more between the calculated weekly
administered dose and the weekly prescribed dose. To ensure that there
is no ambiguity as to the meaning of this provision, it has been
reworded and the key phrase in the rule language has been changed from
``30 percent greater than'' to ``30 percent or more.'' Because this
better expresses the intent of the existing rule and is a minor
administrative correction, the Commission believes that it can be
incorporated in this final rule without having first been included in
the proposed rule.
Recordable event. The existing regulatory text of paragraph (5) of
this definition of ``recordable event'' contains the same word
structure as paragraph (4)(iii) of the definition of misadministration
(discussed above). To ensure that there is no ambiguity as to the
meaning of this provision, it has been reworded and the key phrase in
the rule language has been changed from ``15 percent greater than'' to
``15 percent or more.'' Because this better expresses the intent of the
existing rule and is a minor administrative correction, the Commission
believes that it can be incorporated in this final rule without having
first been included in the proposed rule.
Visiting authorized user. During the public comment period, the
Commission became aware of the need to delete this definition. This
definition is no longer necessary because Sec. 35.27, ``Visiting
authorized user,'' in which this definition is applicable is being
deleted. Therefore, this definition is being removed from the final
rule.
Section 35.6 Provisions for Research Involving Human Subjects
This section contains one modification of the proposed rule
language. The phrase ``in accordance with the meaning of these terms as
defined and described in the Federal Policy for the Protection of Human
Subjects'' has been added at the end of the last sentence of this
section. This phrase has been added to explicitly state that the terms
``informed consent'' and ``IRB approval'' have the same meaning
ascribed to those terms in the Federal Policy for the Protection of
Human Subjects.
Section 35.11 License Required
There is no change between the final rule language and the proposed
rule language. However, licensees are reminded that if a licensee
intends to increase its possession limit for any byproduct material
isotope or add any new byproduct material isotopes, the licensee must
first obtain a license amendment.
Section 35.13 License Amendments
There is no change between the final rule language and the proposed
rule language in this section. However, the purpose of this discussion
is to remind medical use licensees who are not medical institutions
that, pursuant to paragraphs (b)(1) through (b)(4) of this section,
they must review the necessary credentials and approve or disapprove
any individual who is to work as an authorized user or authorized
nuclear pharmacist. In a medical institution, this review and approval
must be performed by its Radiation Safety Committee (see
Sec. 35.22(b)(2)(ii)).
Section 35.14 Notification
This section contains two editorial changes: (1) the phrase
``within 30 days of the date'' has been replaced by the phrase ``no
later than 30 days after the date,'' and (2) the phrase ``the license,
or the permit'' has been replaced by ``the Commission or Agreement
state license, or the permit issued by a licensee of broad scope.''
Section 35.25 Supervision
There is a modification to the proposed rule in this section. The
proposed rule stated that the supervising authorized nuclear pharmacist
or physician authorized user must instruct the workers. The final rule
allows the instruction to be delegated to other qualified individuals.
This change is based on public comments requesting that the instruction
of workers be done by the supervising individuals as well as by other
qualified individuals. However, the requirement for periodically
reviewing the work of supervised individuals remains with the
supervising authorized nuclear pharmacist or physician authorized user.
Section 35.50 Possession, Use, Calibration, and Checks of Dose
Calibrators
There is an editorial change in this section. The phrase in the
proposed rule ``over the range of its use between ______ and ______''
has been replaced by ``over a range from ______ to ______.''
Section 35.900 Radiation Safety Officer
Two additional board certifications have been recognized in this
section of the final rule.
During the public comment period, the Commission became aware of
the need to recognize certifications by the American Osteopathic Board
of Nuclear Medicine (AOBNM) and the American Osteopathic Board of
Radiology (AOBR). A letter dated August 16, 1990, from Richard E.
Cunningham (Director, Division of Industrial and Medical Nuclear
Safety, NRC), to Paul J. Chase (Chairman, AOBR and Vice President,
AOBNM), stated that the NRC intended to include certifications of (1)
AOBR in Sec. 35.900, and (2) AOBNM in Secs. 35.900, 35.910, and 35.920
in the next amendment to 10 CFR Part 35. Therefore, the certifications
by AOBR and AOBNM have been added to this section of the final rule.
Section 35.910 Training for Uptake, Dilution, and Excretion Studies
Section 35.920 Training for Imaging and Localization Studies
One additional board certification has been recognized in both
sections of the final rule.
As discussed in the previous section, the Commission became aware
of the need to recognize certification by AOBNM. Therefore, the
certification by AOBNM has been added to both sections of the final
rule.
Section 35.930 Training for Therapeutic Use of Unsealed Byproduct
Material
Two additional board certifications have been recognized in this
section of the final rule.
A comment stated that certification by the American Osteopathic
Board of Radiology (AOBR) should be recognized in all applicable
sections of 10 CFR Part 35. Under the existing regulations, the
Commission has recognized AOBR certification in Secs. 35.910, 35,920,
35.940, 35.950, and 35.960.
Following receipt of this comment, the Commission requested
additional information from AOBR concerning training and certification
criteria for therapeutic use of unsealed byproduct material. After
reviewing supporting documents provided by the American Osteopathic
College of Radiology (AOCR), the Commission has determined that AOBR
certification is equivalent to certification by the American Board of
Radiology (ABR). Therefore, recognition of certification by AOBR has
been added in Sec. 35.930 of this final rule for certification granted
after 1984 because all candidates certified by AOBR since 1984 will
meet the NRC's training requirements.
During the public comment period, the Commission also became aware
of the need to recognize in Sec. 35.930 certification by the Royal
College of Physicians and Surgeons of Canada. This is in addition to
the recognition reflected in Secs. 35.900, 35.910, and 35.920 of the
proposed rule. A letter dated June 3, 1992, from John E. Glenn (Chief,
Medical, Academic and Commercial Use Safety Branch, Division of
Industrial and Medical Nuclear Safety, NRC), to Gilles D. Hurteau of
the Royal College of Physicians and Surgeons of Canada, stated that
certification by the latter is acceptable for approval, among other
things, as an authorized user in Sec. 35.300. Therefore, certification
by the Royal College of Physicians and Surgeons of Canada has been
added to this section of the final rule.
Section 35.981 Training for Experienced Nuclear Pharmacists
This section was not included in the proposed rule, but has been
added to the final rule in response to numerous comments. This section
has been patterned after the provisions in 10 CFR Part 32 for
``grandfathering'' an ``authorized user.''
To ``grandfather'' an experienced nuclear pharmacist, the licensee
needs to apply for a license amendment identifying that individual as
an authorized nuclear pharmacist. The licensee must receive the license
amendment before allowing that individual to work as an authorized
nuclear pharmacist.
A licensee seeking to ``grandfather'' a nuclear pharmacist must
ensure that the individual has completed a structured educational
program as specified in Sec. 35.980(b)(1) on or before (the date of
publication in the Federal Register) and is currently working as a
nuclear pharmacist. However, the individual does not need a preceptor
statement (Sec. 35.980(b)(2)) and the individual's training, specified
above, does not need to be within 7 years preceding the date of
application (Sec. 35.972).
Agreement State Compatibility
There were numerous public comments concerning compatibility. The
commenters offered a wide range of opinions, from those recommending no
compatibility to those favoring identical requirements between
Agreement States and the NRC. These comments and NRC's responses will
be discussed at the end of this section.
After considering the comments, the Commission has determined that
the compatibility levels for the final rule should remain the same as
the proposed rule. All definitions contained in Secs. 30.4 and 35.2
that are established or modified by this rulemaking are Division 1
levels of compatibility. These definitions must be the same for all NRC
and Agreement State licensees so that national consistency can be
maintained.
Additionally, Secs. 32.72, 35.6, 35.22(b)(2), 35.25, 35.50, 35.52,
35.53, 35.920, 35.972, 35.980, and 35.981 are Division 2 levels of
compatibility because requirements at least this stringent are
necessary to ensure adequate protection of the public health and
safety. The Agreement States will be allowed to establish requirements
that are more stringent than the NRC's requirements, but not less
stringent.
It would be appropriate for Agreement States to adopt the remaining
sections of these revisions to Part 35 in this rulemaking, but it is
not necessary to require any degree of compatibility between NRC and
the States. Therefore, a Division 3 level of compatibility is
appropriate for these sections.
The Commission is currently developing a new policy on Agreement
State compatibility. This development will include involvement of the
Agreement States and the general public. At the conclusion of this
effort, the Commission will implement guidance on the application of
adequacy and compatibility and in light of the new guidance will
reassess the existing compatibility levels.
The Commission expects Agreement States to adopt rules required to
maintain compatibility within 3 years after NRC's rules become
effective. However, the States may elect to implement on a temporary
basis the requirements contained in this final rule through license
conditions prior to promulgation of the rule necessary for
compatibility. In the preamble of the notice of the proposed rule, the
Commission stated that some Agreement States, faced with administrative
and resource constraints, may find the 3-year time period difficult to
attain and may prefer that NRC extend flexibility in such cases to
allow the States to implement the requirements through license
conditions. In the same notice, the Commission requested public comment
on permitting Agreement States flexibility in this regard, and if
permitted, under what conditions.
The NRC did not receive any comments on implementing requirements
through license conditions. Under current policy, the Agreement States
have the flexibility to implement the requirements contained in this
final rule on a temporary basis through license conditions, until they
adopt compatible rules. In addition, this issue will be addressed in
the development of a new policy statement on adequacy and
compatibility.
There were numerous comments related to Agreement State
compatibility. These comments and the NRC's responses are summarized
below.
(1) Comment. It is inappropriate for the NRC to use the existing
policy for compatibility determinations regarding this rulemaking
because the NRC is currently considering a new policy.
Response. The Commission must use the existing policy for
compatibility determinations regarding all rulemakings until the new
policy becomes effective. At that time, the Commission expects that the
existing compatibility determinations will be reviewed in light of the
new policy.
(2) Comment. There is an increasing tendency of NRC to use the term
``safety significance'' in justifying the NRC's position on
compatibility determination. But the question is, ``How much
significance?''
Response. Under the existing policy the Commission considers the
safety significance of a particular requirement, i.e., whether it is
necessary to ensure adequate protection of the public health and
safety, in determining whether it should be an item of Agreement State
compatibility. If it is necessary to ensure adequate protection, the
requirement will, at a minimum, be Division 2 level of compatibility.
In addition, if the requirement is both necessary for adequate
protection and clear communication, it will be a Division 1 level of
compatibility. Using these criteria, the Commission has made the
findings on compatibility described above. The basic objective of these
findings is to ensure that the public receives adequate radiation
protection during medical procedures without undue interference in the
practices of pharmacy and medicine. The relationship between
compatibility and health and safety will be clarified in the new policy
on Agreement State compatibility.
(3) Comment. Some commenters suggested that Agreement States'
requirements should be identical to NRC's requirements. Other
commenters suggested that a high degree of consistency between
Agreement States and the NRC on medical rules is not necessary.
Response. The Commission believes in some cases, that it is
necessary for Agreement States' regulations to be essentially verbatim,
i.e., identical, to NRC regulations. In other cases, it is necessary
for the Agreement States to adopt the provisions in a consistent
although not identical form. As discussed above in the response to
comment (2), the Commission has determined which provisions of this
rule are a Division 1 level of compatibility. Except for definitions
which are a Division 1 level of compatibility, all other provisions of
this final rule are either Division 2 or 3 levels of compatibility.
Thus, for this final rule, uniformity is not required between Agreement
States and the NRC for all provisions.
(4) Comment. Medical facilities are essentially fixed facilities
with little or no implications for interstate commerce. Where is the
justification for the NRC's position?
Response. In the proposed rule, the NRC did not state that the
reason for the proposed compatibility levels was due to interstate
commerce implications. As stated earlier, the justifications for
compatibility are as follows. All definitions contained in Secs. 30.4
and 35.2 that are established or modified by this rulemaking are
Division 1 levels of compatibility. These definitions must be the same
for all NRC and Agreement State licensees so that national consistency
can be maintained. Also, certain specific sections are Division 2
levels of compatibility because requirements at least this stringent
are necessary to ensure adequate protection of the public health and
safety.
(5) Comment. The proposed rule stated that all definitions in
Secs. 30.4 and 35.2 would be Division 1 levels of compatibility. This
would include definitions in Sec. 30.4 that do not relate to medical
uses and should not be affected by this rulemaking.
Response. The language in the preamble for the proposed rule
intended to indicate that all definitions in Secs. 30.4 and 35.2 that
are established or modified by this rulemaking would be Division 1
levels of compatibility. Levels of compatibility for other definitions
in existing Secs. 30.4 and 35.2 that are not modified in this
rulemaking will remain unchanged. The language in this preamble has
been modified to clarify this point.
(6) Comment. Based on the State Agreements Program Procedure B.7,
all Part 35 items categorized in that procedure are Division 3.
Response. Before the quality management program and
misadministration rulemaking became effective, all sections in Part 35
were Division 3 levels of compatibility. However, following that
amendment (56 FR 34104; July 25, 1991), the levels of compatibility for
Part 35 were modified as follows: The definitions associated with the
quality management rule and misadministrations in Sec. 35.2 became
Division 1 levels of compatibility; Secs. 35.32 and 35.33 became
Division 2 levels of compatibility; Sec. 35.8 became a Division 4 level
of compatibility; and all other sections of Part 35 remained Division 3
levels of compatibility.
(7) Comment. The proposed rule stated that Agreement States are
expected to adopt rules required to maintain compatibility within 3
years. Agreement States should be able to adopt this rulemaking in a
shorter time.
Response. Some Agreement States may need less time to adopt certain
parts of this rulemaking. Other Agreement States may need the full 3
years to adopt the rule because of constraints on resources. Therefore,
the Commission retains the 3-year period for adopting this rule. In
reevaluating its compatibility policy, the Commission is considering
whether the time can be shortened when demonstrable health and safety
considerations require it.
(8) Comment. What would happen if an Agreement State fails to adopt
requirements that are items of compatibility?
Response. During the periodic review of the Agreement State's
program, the NRC would determine whether the State meets the
compatibility requirements. If not, the State would be notified that
its program must be compatible with the NRC's requirements, and using
current procedures a finding of compatibility for the Agreement State
program would be withheld. Such a failure, if uncorrected or
unjustified, could lead to the loss of the State's status as an
Agreement State.
(9) Comment. Creating a Division 1 or Division 2 level of
compatibility for parts of this rule may cause conflict with State
boards of pharmacy and medicine.
Response. The provisions contained in this rulemaking that require
a Division 1 or Division 2 level of compatibility are necessary to
provide an adequate level of protection of public health and safety
from radiological hazards. In addition, the Commission is not aware of
any conflicts between these provisions and the requirements of State
boards of pharmacy and medicine.
IV. Administrative Statements
Finding of No Significant Environmental Impact: Availability
The Commission has determined under the National Environmental
Policy Act of 1969, as amended, and the Commission's regulations in
Subpart A of 10 CFR Part 51, that this final amendment is not a major
Federal action significantly affecting the quality of the human
environment, and therefore an environmental impact statement is not
required. The final amendment provides greater flexibility for
physician authorized users to use byproduct material in the practice of
medicine. The final amendment will also incorporate into the
regulations the concept of authorized nuclear pharmacists to permit
properly qualified pharmacists to prepare radioactive drugs containing
byproduct material in the practice of pharmacy.
The final rule will allow physician authorized users greater
discretion to prepare and use radioactive drugs containing byproduct
material. The final rule will also allow authorized nuclear pharmacists
greater discretion to prepare radioactive drugs containing byproduct
material. It is expected that there will be no increase in radiation
exposure to the public or to the environment beyond the exposures
currently resulting from delivering the byproduct material or radiation
from byproduct material to patients or human research subjects. The
environmental assessment and finding of no significant impact on which
this determination is based is available for inspection at the NRC
Public Document Room, 2120 L Street NW. (Lower Level), Washington, DC.
Single copies of the environmental assessment and the finding of no
significant impact are available from Anthony N. Tse (see FOR FURTHER
INFORMATION CONTACT heading).
Paperwork Reduction Act Statement
This final rule amends information collection requirements that are
subject to the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et seq).
These requirements were approved by the Office of Management and
Budget, approval numbers 3150-0001 and 3150-0010 for amendments to 10
CFR Parts 32 and 35, respectively.
The reduction in public burden for this collection of information
is estimated to be a savings of 408 hours per year for 300 NRC
licensees, or an average 1.4 hours per year per licensee, including the
time for reviewing instructions, searching existing data sources,
gathering and maintaining the data needed, and completing and reviewing
the collection of information. Send comments regarding this burden
estimate or any other aspect of this collection of information,
including suggestions for reducing this burden, to the Information and
Records Management Branch (T-6 F33), U.S. Nuclear Regulatory
Commission, Washington, DC 20555, and to the Desk Officer, Office of
Information and Regulatory Affairs, NEOB-10202, (3150-0001, -0010, and
-0120), Office of Management and Budget, Washington, DC 20503.
Regulatory Analysis
The Commission has prepared a final regulatory analysis on this
regulation. The analysis examines the benefits and impacts considered
by the Commission. No public comments were received on the draft
regulatory analysis associated with the proposed rule. The final
regulatory analysis is available for inspection at the NRC Public
Document Room at 2120 L Street NW. (Lower Level), Washington, DC.
Single copies of the draft analysis are available from Anthony N. Tse
(see FOR FURTHER INFORMATION CONTACT heading).
Regulatory Flexibility Certification
As required by the Regulatory Flexibility Act of 1980, 5 U.S.C.
605(b), the Commission certifies that this rule will not have a
significant economic impact on a substantial number of small entities.
This rule affects medical use licensees including some private practice
physicians. Some of these licensees would be considered small entities
under the NRC's size standards (56 FR 56671; November 6, 1991). The
amendments provide greater discretion for physician authorized users to
use byproduct material in the practice of medicine. The amendments will
also incorporate into the regulations the concept of authorized nuclear
pharmacists to allow properly qualified pharmacists greater discretion
to prepare (including compound) radioactive drugs containing byproduct
material for medical use. This rule is expected to reduce regulatory
burdens on medical use licensees, including small entities. No public
comments were received related to the regulatory flexibility
certification associated with the proposed rule.
Backfit Analysis
The Commission has determined that the backfit rule, 10 CFR 50.109,
does not apply to this amendment because this amendment does not
involve any provisions which would impose backfits as defined in 10 CFR
50.109(a)(1). Therefore, a backfit analysis is not required for this
amendment.
List of Subjects
10 CFR Part 30
Byproduct material, Criminal penalties, Government contracts,
Intergovernmental relations, Isotopes, Nuclear materials, Radiation
protection, Reporting and recordkeeping requirements.
10 CFR Part 32
Byproduct material, Criminal Penalties, Labeling, Nuclear
materials, Radiation protection, Reporting and recordkeeping
requirements.
10 CFR Part 35
Byproduct material, Criminal penalties, Drugs, Health facilities,
Health professions, Medical devices, Nuclear materials, Occupational
safety and health, Radiation protection, Reporting and recordkeeping
requirements.
For the reasons set out in the preamble and under the authority of
the Atomic Energy Act of 1954, as amended, the Energy Reorganization
Act of 1974, as amended, and 5 U.S.C. 552 and 553, the Commission is
adopting the following amendments to 10 CFR Parts 30, 32, and 35.
V. Text of Final Regulations
PART 30--RULES OF GENERAL APPLICABILITY TO DOMESTIC LICENSING OF
BYPRODUCT MATERIAL
1. The authority citation for Part 30 continues to read as follows:
Authority: Secs. 81, 82, 161, 182, 183, 186, 68 Stat. 935, 948,
953, 954, 955, as amended, sec. 234, 83 Stat. 444, as amended (42
U.S.C. 2111, 2112, 2201, 2232, 2233, 2236, 2282); secs. 201, as
amended, 202, 206, 88 Stat. 1242, as amended, 1244, 1246 (42 U.S.C.
5841, 5842, 5846).
Section 30.7 also issued under Pub. L. 95-601, sec. 10, 92 Stat.
2951 as amended by Pub. L. 102-486, Sec. 2902, 106 Stat. 3123, (42
U.S.C. 5851). Section 30.34(b) also issued under sec. 184, 68 Stat.
954, as amended (42 U.S.C. 2234). Section 30.61 also issued under
sec. 187, 68 Stat. 955 (42 U.S.C. 2237).
2. In Sec. 30.4, the definition of medical use is revised to read
as follows:
Sec. 30.4 Definitions.
* * * * *
Medical use means the intentional internal or external
administration of byproduct material or the radiation therefrom to
patients or human research subjects under the supervision of an
authorized user as defined in 10 CFR Part 35.
* * * * *
3. In Sec. 30.8, paragraphs (b) and (c) are revised to read as
follows:
Sec. 30.8 Information collection requirements: OMB approval.
* * * * *
(b) The approved information collection requirements contained in
this part appear in Secs. 30.9, 30.11, 30.15, 30.19, 30.20, 30.32,
30.34, 30.35, 30.36, 30.37, 30.38, 30.41, 30.50, 30.51, 30.55, and
Appendix A.
(c) This part contains information collection requirements in
addition to those approved under the control number specified in
paragraph (a) of this section. These information collection
requirements and the control numbers under which they are approved are
as follows:
(1) In Secs. 30.32, 30.37, and 30.38, NRC Form 313 is approved
under control number 3150-0120.
(2) In Sec. 30.36, NRC Form 314 is approved under control number
3150-0028.
Sec. 30.34 [Amended]
4. Section 30.34 is amended by removing paragraph (i) in its
entirety.
PART 32--SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER
CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL
5. The authority citation for Part 32 continues to read as follows:
Authority: Secs. 81, 161, 182, 183, 68 Stat. 935, 948, 953, 954,
as amended (42 U.S.C. 2111, 2201, 2232, 2233); sec. 201, 88 Stat.
1242, as amended (42 U.S.C. 5841).
6. In Sec. 32.8, paragraphs (b) and (c) are revised to read as
follows:
Sec. 32.8 Information collection requirements: OMB approval.
* * * * *
(b) The approved information collection requirements contained in
this part appear in Secs. 32.12, 32.14, 32.15, 32.16, 32.17, 32.18,
32.19, 32.20, 32.22, 32.23, 32.25, 32.26, 32.27, 32.29, 32.51, 32.51a,
32.52, 32.53, 32.54, 32.55, 32.56, 32.57, 32.58, 32.61, 32.62, 32.70,
32.71, 32.72, and 32.74.
(c) This part contains information collection requirements in
addition to those approved under the control number specified in
paragraph (a) of this section. These information collection
requirements and the control numbers under which they are approved are
as follows:
(1) In Sec. 32.11, NRC Form 313 is approved under control number
3150-0120.
7. Section 32.72 is revised to read as follows:
Sec. 32.72 Manufacture, preparation, or transfer for commercial
distribution of radioactive drugs containing byproduct material for
medical use under Part 35.
(a) An application for a specific license to manufacture, prepare,
or transfer for commercial distribution radioactive drugs containing
byproduct material for use by persons authorized pursuant to Part 35 of
this chapter will be approved if:
(1) The applicant satisfies the general requirements specified in
10 CFR 30.33;
(2) The applicant submits evidence that the applicant is at least
one of the following:
(i) Registered or licensed with the U.S. Food and Drug
Administration (FDA) as a drug manufacturer;
(ii) Registered or licensed with a state agency as a drug
manufacturer;
(iii) Licensed as a pharmacy by a State Board of Pharmacy; or
(iv) Operating as a nuclear pharmacy within a Federal medical
institution.
(3) The applicant submits information on the radionuclide; the
chemical and physical form; the maximum activity per vial, syringe,
generator, or other container of the radioactive drug; and the
shielding provided by the packaging to show it is appropriate for the
safe handling and storage of the radioactive drugs by medical use
licensees; and
(4) A label is affixed to each container of a radioactive drug to
be transferred for commercial distribution. The label must include the
name of the radioactive drug or its abbreviation, quantity of
radioactivity, and date and time of assay. For radioactive drugs with a
half life greater than 100 days the time of assay may be omitted. In
addition, the label for the syringe or syringe radiation shield must
also contain the clinical procedure to be performed or the patient's or
the human research subject's name. Furthermore, the label, or the
leaflet or brochure that accompanies the radioactive drug, must contain
a statement that the U.S. Nuclear Regulatory Commission has approved
distribution of the byproduct material to persons licensed to use
byproduct material pursuant to 10 CFR 35.100, 35.200, or 35.300, as
appropriate, and to persons who hold an equivalent license issued by an
Agreement State. The Commission's labeling requirements are independent
of requirements of the U.S. Food and Drug Administration (FDA); one
label is acceptable to NRC provided that it contains all of the
information which NRC requires.
(b) A licensee described by paragraph (a)(2)(iii) or (iv) of this
section:
(1) May prepare radioactive drugs for medical use, as defined in 10
CFR 35.2, provided that the radioactive drug is prepared by either an
authorized nuclear pharmacist, as specified in paragraph (b)(2) and
(b)(3) of this section, or an individual under the supervision of an
authorized nuclear pharmacist as specified in 10 CFR 35.25.
(2) May allow a pharmacist to work as an authorized nuclear
pharmacist if:
(i) This individual qualifies as an authorized nuclear pharmacist
as defined in 10 CFR 35.2,
(ii) This individual meets the requirements specified in 10 CFR
35.980(b) and 35.972 and the licensee has received an approved license
amendment identifying this individual as an authorized nuclear
pharmacist, or
(iii) This individual is designated as an authorized nuclear
pharmacist in accordance with paragraph (b)(3) of this section.
(3) The actions authorized in paragraphs (b)(1) and (b)(2) of this
section are permitted in spite of more restrictive language in license
conditions.
(4) May designate a pharmacist (as defined in 10 CFR 35.2) as an
authorized nuclear pharmacist if the individual is identified as of
(the date of publication in the Federal Register) as an ``authorized
user'' on a nuclear pharmacy license issued by the Commission under
this part.
(5) Shall provide to the Commission a copy of each individual's
certification by the Board of Pharmaceutical Specialties, the
Commission or Agreement State license, or the permit issued by a
licensee of broad scope, and a copy of the state pharmacy licensure or
registration, no later than 30 days after the date that the licensee
allows, pursuant to paragraphs (b)(2)(i) and (b)(2)(iii) of this
section, the individual to work as an authorized nuclear pharmacist.
(c) A licensee shall possess and use instrumentation to measure the
radioactivity of radioactive drugs. The licensee shall have procedures
for use of the instrumentation. The licensee shall measure, by direct
measurement or by combination of measurements and calculations, the
amount of radioactivity in dosages of alpha-, beta-, or photon-emitting
radioactive drugs prior to transfer for commercial distribution. In
addition, the licensee shall:
(1) Perform tests before initial use, periodically, and following
repair, on each instrument for accuracy, linearity, and geometry
dependence, as appropriate for the use of the instrument; and make
adjustments when necessary; and
(2) Check each instrument for constancy and proper operation at the
beginning of each day of use.
(d) Nothing in this section relieves the licensee from complying
with applicable FDA, other Federal, and State requirements governing
radioactive drugs.
Sec. 32.73 [Removed]
8. Section 32.73 is removed.
9. In Sec. 32.303, paragraph (b) is revised to read as follows:
Sec. 32.303 Criminal penalties.
* * * * *
(b) The regulations in Part 32 that are not issued under
subsections 161b, 161i, or 161o for the purposes of section 223 are as
follows: Secs. 32.1, 32.2, 32.8, 32.11, 32.14, 32.17, 32.18, 32.22,
32.23, 32.24, 32.26, 32.27, 32.28, 32.51, 32.53, 32.57, 32.61, 32.71,
32.74, 32.301, and 32.303.
PART 35--MEDICAL USE OF BYPRODUCT MATERIAL
10. The authority citation for Part 35 continues to read as
follows:
Authority: Secs. 81, 161, 182, 183, 68 Stat. 935, 948, 953, 954,
as amended (42 U.S.C. 2111, 2201, 2232, 2233); sec. 201, 88 Stat.
1242, as amended (42 U.S.C. 5841).
11. In Sec. 35.2, the definition of visiting authorized user is
removed; the definitions of authorized nuclear pharmacist and
pharmacist are added; and the definitions of authorized user, medical
use, misadministration--paragraphs (1)(i), (2)(i), (3)(i), (4)(i),
(4)(iii), (5)(i), (6)(i), and (6)(ii), recordable event--paragraph (5),
and written directive--the introductory text, are revised to read as
follows:
Sec. 35.2 Definitions.
* * * * *
Authorized nuclear pharmacist means a pharmacist who is:
(1) Board certified as a nuclear pharmacist by the Board of
Pharmaceutical Specialties;
(2) Identified as an authorized nuclear pharmacist on a Commission
or Agreement State license that authorizes the use of byproduct
material in the practice of nuclear pharmacy; or
(3) Identified as an authorized nuclear pharmacist on a permit
issued by a Commission or Agreement State specific licensee of broad
scope that is authorized to permit the use of byproduct material in the
practice of nuclear pharmacy.
Authorized user means a physician, dentist, or podiatrist who is:
(1) Board certified by at least one of the boards listed in
Paragraph (a) of Secs. 35.910, 35.920, 35.930, 35.940, 35.950, or
35.960;
(2) Identified as an authorized user on a Commission or Agreement
State license that authorizes the medical use of byproduct material; or
(3) Identified as an authorized user on a permit issued by a
Commission or Agreement State specific licensee of broad scope that is
authorized to permit the medical use of byproduct material.
* * * * *
Medical use means the intentional internal or external
administration of byproduct material or the radiation therefrom to
patients or human research subjects under the supervision of an
authorized user.
* * * * *
Misadministration means the administration of:
(1) * * *
(i) Involving the wrong patient or human research subject, or wrong
radiopharmaceutical; or
* * * * *
(2) * * *
(i) Involving the wrong patient or human research subject, wrong
radiopharmaceutical, or wrong route of administration; or
* * * * *
(3) * * *
(i) Involving the wrong patient or human research subject, or wrong
treatment site; or
* * * * *
(4) * * *
(i) Involving the wrong patient or human research subject, wrong
mode of treatment, or wrong treatment site;
* * * * *
(iii) When the calculated weekly administered dose exceeds the
weekly prescribed dose by 30 percent or more of the weekly prescribed
dose; or
* * * * *
(5) * * *
(i) Involving the wrong patient or human research subject, wrong
radioisotope, or wrong treatment site (excluding, for permanent
implants, seeds that were implanted in the correct site but migrated
outside the treatment site);
* * * * *
(6) * * *
(i) Involving the wrong patient or human research subject, wrong
radiopharmaceutical, wrong route of administration, or when the
administered dosage differs from the prescribed dosage; and
(ii) When the dose to the patient or human research subject exceeds
5 rems effective dose equivalent or 50 rems dose equivalent to any
individual organ.
* * * * *
Pharmacist means an individual licensed by a State or Territory of
the United States, the District of Columbia, or the Commonwealth of
Puerto Rico to practice pharmacy.
* * * * *
Recordable event means the administration of:
* * * * *
(5) A teletherapy radiation dose when the calculated weekly
administered dose exceeds the weekly prescribed dose by 15 percent or
more of the weekly prescribed dose; or
* * * * *
Written directive means an order in writing for a specific patient
or human research subject, dated and signed by an authorized user prior
to the administration of a radiopharmaceutical or radiation, except as
specified in paragraph (6) of this definition, containing the following
information:
* * * * *
12. Section 35.6 is added to read as follows:
Sec. 35.6 Provisions for research involving human subjects.
A licensee may conduct research involving human subjects using
byproduct material provided that the research is conducted, funded,
supported, or regulated by another Federal Agency which has implemented
the Federal Policy for the Protection of Human Subjects. Otherwise, a
licensee shall apply for and receive approval of a specific amendment
to its NRC license before conducting such research. Both types of
licensees shall, at a minimum, obtain informed consent from the human
subjects and obtain prior review and approval of the research
activities by an ``Institutional Review Board'' in accordance with the
meaning of these terms as defined and described in the Federal Policy
for the Protection of Human Subjects.
13. Section 35.7 is added to read as follows:
Sec. 35.7 FDA, other Federal, and State requirements.
Nothing in this part relieves the licensee from complying with
applicable FDA, other Federal, and State requirements governing
radioactive drugs or devices.
14. In Sec. 35.8, paragraph (b) is revised to read as follows:
Sec. 35.8 Information collection requirements: OMB approval.
* * * * *
(b) The approved information collection requirements contained in
this part appear in Secs. 35.6, 35.12, 35.13, 35.14, 35.21, 35.22,
35.23, 35.29, 35.31, 35.50, 35.51, 35.52, 35.53, 35.59, 35.60, 35.61,
35.70, 35.80, 35.92, 35.204, 35.205, 35.310, 35.315, 35.404, 35.406,
35.410, 35.415, 35.606, 35.610, 35.615, 35.630, 35.632, 35.634, 35.636,
35.641, 35.643, 35.645, 35.647, 35.980, and 35.981.
* * * * *
15. In Sec. 35.11, paragraph (a) is revised and paragraph (c) is
added to read as follows:
Sec. 35.11 License required.
(a) A person shall not manufacture, produce, acquire, receive,
possess, use, or transfer byproduct material for medical use except in
accordance with a specific license issued by the Commission or an
Agreement State, or as allowed in paragraph (b) or (c) of this section.
* * * * *
(c) An individual may prepare unsealed byproduct material for
medical use in accordance with the regulations in this chapter under
the supervision of an authorized nuclear pharmacist or authorized user
as provided in Sec. 35.25, unless prohibited by license condition.
16. In Sec. 35.12, paragraph (e) is added to read as follows:
Sec. 35.12 Application for license, amendment, or renewal.
* * * * *
(e) An applicant that satisfies the requirements specified in 10
CFR 33.13 may apply for a Type A specific license of broad scope.
17. In Sec. 35.13, paragraph (b) is revised to read as follows:
Sec. 35.13 License amendments.
* * * * *
(b) Before it permits anyone to work as an authorized user or
authorized nuclear pharmacist under the license, except an individual
who is:
(1) An authorized user certified by the organizations specified in
paragraph (a) of Sec. 35.910, 35.920, 35.930, 35.940, 35.950, or
35.960;
(2) An authorized nuclear pharmacist certified by the organization
specified in paragraph (a) of Sec. 35.980;
(3) Identified as an authorized user or an authorized nuclear
pharmacist on a Commission or Agreement State license that authorizes
the use of byproduct material in medical use or in the practice of
nuclear pharmacy, respectively; or
(4) Identified as an authorized user or an authorized nuclear
pharmacist on a permit issued by a Commission or Agreement State
specific licensee of broad scope that is authorized to permit the use
of byproduct material in medical use or in the practice of nuclear
pharmacy, respectively.
* * * * *
18. Section 35.14 is revised to read as follows:
Sec. 35.14 Notifications.
(a) A licensee shall provide to the Commission a copy of the board
certification, the Commission or Agreement State license, or the permit
issued by a licensee of broad scope for each individual no later than
30 days after the date that the licensee permits the individual to work
as an authorized user or an authorized nuclear pharmacist pursuant to
Sec. 35.13 (b)(1) through (b)(4).
(b) A licensee shall notify the Commission by letter no later than
30 days after:
(1) An authorized user, an authorized nuclear pharmacist, Radiation
Safety Officer, or teletherapy physicist permanently discontinues
performance of duties under the license or has a name change; or
(2) The licensee's mailing address changes.
(c) The licensee shall mail the documents required in this section
to the appropriate address identified in Sec. 30.6 of this chapter.
19. Section 35.15 is added to read as follows:
Sec. 35.15 Exemptions regarding Type A specific licenses of broad
scope.
A licensee possessing a Type A specific license of broad scope for
medical use is exempt from the following:
(a) The provisions of Sec. 35.13(b);
(b) The provisions of Sec. 35.13(e) regarding additions to or
changes in the areas of use only at the addresses specified in the
license;
(c) The provisions of Sec. 35.14(a); and
(d) The provisions of Sec. 35.14(b)(1) for an authorized user or an
authorized nuclear pharmacist.
20. In Sec. 35.22, paragraph (b)(2) is revised to read as follows:
Sec. 35.22 Radiation Safety Committee.
* * * * *
(b) * * *
(2)(i) Review, on the basis of safety and with regard to the
training and experience standards in Subpart J of this part, and
approve or disapprove any individual who is to be listed as an
authorized user, an authorized nuclear pharmacist, the Radiation Safety
Officer, or a teletherapy physicist before submitting a license
application or request for amendment or renewal; or
(ii) Review, pursuant to Sec. 35.13 (b)(1) through (b)(4), on the
basis of the board certification, the license, or the permit
identifying an individual, and approve or disapprove any individual
prior to allowing that individual to work as an authorized user or
authorized nuclear pharmacist;
* * * * *
21. In Sec. 35.25, paragraph (b) is redesignated as paragraph (c)
and a new paragraph (b) is added to read as follows.
Sec. 35.25 Supervision.
* * * * *
(b) A licensee that permits the preparation of byproduct material
for medical use by an individual under the supervision of an authorized
nuclear pharmacist or physician who is an authorized user, as allowed
by Sec. 35.11(c), shall:
(1) Instruct the supervised individual in the preparation of
byproduct material for medical use and the principles of and procedures
for radiation safety and in the licensee's written quality management
program, as appropriate to that individual's use of byproduct material;
(2) Require the supervised individual to follow the instructions
given pursuant to paragraph (b)(1) of this section and to comply with
the regulations of this chapter and license conditions; and
(3) Require the supervising authorized nuclear pharmacist or
physician who is an authorized user to periodically review the work of
the supervised individual as it pertains to preparing byproduct
material for medical use and the records kept to reflect that work.
* * * * *
Sec. 35.27 [Removed]
22. Section 35.27 is removed.
23. In Sec. 35.32, paragraphs (a)(2) and (b)(1)(i) are revised to
read as follows:
Sec. 35.32 Quality management program.
(a) * * *
(2) That, prior to each administration, the patient's or human
research subject's identity is verified by more than one method as the
individual named in the written directive;
* * * * *
(b) * * *
(1) * * *
(i) A representative sample of patient and human research subject
administrations,
* * * * *
24. In Sec. 35.33, paragraphs (a)(2), (a)(3), (a)(4), (b), and (c)
are revised to read as follows:
Sec. 35.33 Notifications, reports, and records of misadministrations.
(a) * * *
(2) The licensee shall submit a written report to the appropriate
NRC Regional Office listed in 10 CFR 30.6 within 15 days after
discovery of the misadministration. The written report must include the
licensee's name; the prescribing physician's name; a brief description
of the event; why the event occurred; the effect on the patient or the
human research subject; what improvements are needed to prevent
recurrence; actions taken to prevent recurrence; whether the licensee
notified the patient or the human research subject or the patient's or
the human research subject's responsible relative or guardian (this
individual will subsequently be referred to as ``the patient or human
research subject''), and if not, why not, and if the patient or the
human research subject was notified, what information was provided to
that individual. The report must not include the patient's or the human
research subject's name or other information that could lead to
identification of the patient or the human research subject.
(3) The licensee shall notify the referring physician and also
notify the patient or the human research subject of the
misadministration no later than 24 hours after its discovery, unless
the referring physician personally informs the licensee either that he
will inform the patient or the human research subject or that, based on
medical judgment, telling the patient or the human research subject
would be harmful to the patient or the human research subject. The
licensee is not required to notify the patient or the human research
subject without first consulting the referring physician. If the
referring physician or the patient or the human research subject cannot
be reached within 24 hours, the licensee shall notify the patient or
the human research subject as soon as possible thereafter. The licensee
may not delay any appropriate medical care for the patient or the human
research subject, including any necessary remedial care as a result of
the misadministration, because of any delay in notification.
(4) If the patient or the human research subject was notified, the
licensee shall also furnish, within 15 days after discovery of the
misadministration, a written report to the patient or the human
research subject by sending either:
(i) A copy of the report that was submitted to the NRC; or
(ii) A brief description of both the event and the consequences as
they may affect the patient or the human research subject, provided a
statement is included that the report submitted to the NRC can be
obtained from the licensee.
(b) Each licensee shall retain a record of each misadministration
for five years. The record must contain the names of all individuals
involved (including the prescribing physician, allied health personnel,
the patient or the human research subject, and the patient's or human
research subject's referring physician), the patient's or the human
research subject's social security number or identification number if
one has been assigned, a brief description of the misadministration,
why it occurred, the effect on the patient or the human research
subject, what improvements are needed to prevent recurrence, and the
actions taken to prevent recurrence.
(c) Aside from the notification requirement, nothing in this
section affects any rights or duties of licensees and physicians in
relation to each other, patients, or human research subjects (or the
patient's or the human research subject's responsible relative or
guardian).
25. Section 35.49 is revised to read as follows:
Sec. 35.49 Suppliers for sealed sources or devices for medical use.
A licensee may use for medical use only:
(a) Sealed sources or devices manufactured, labeled, packaged, and
distributed in accordance with a license issued pursuant to 10 CFR Part
30 and 10 CFR 32.74 or the equivalent requirements of an Agreement
State; or
(b) Teletherapy sources manufactured and distributed in accordance
with a license issued pursuant to 10 CFR Part 30 or the equivalent
requirements of an Agreement State.
26. In Sec. 35.50, paragraphs (a), (b)(3), and (e)(2) through
(e)(4) are revised to read as follows:
Sec. 35.50 Possession, use, calibration, and check of dose
calibrators.
(a) A licensee shall possess and use a dose calibrator to measure
the activity of dosages of photon-emitting radionuclides prior to
administration to each patient or human research subject.
(b) * * *
(3) Test each dose calibrator for linearity upon installation and
at least quarterly thereafter over a range from the highest dosage that
will be administered to a patient or human research subject to 1.1
megabecquerels (30 microcuries); and
* * * * *
(e) * * *
(2) For paragraph (b)(2) of this section, the model and serial
number of the dose calibrator, the model and serial number of each
source used, the identity of the radionuclide contained in the source
and its activity, the date of the test, the results of the test, and
the identity of the individual performing the test.
(3) For paragraph (b)(3) of this section, the model and serial
number of the dose calibrator, the calculated activities, the measured
activities, the date of the test, and the identity of the individual
performing the test.
(4) For paragraph (b)(4) of this section, the model and serial
number of the dose calibrator, the configuration of the source
measured, the activity measured for each volume measured, the date of
the test, and the identity of the individual performing the test.
27. Section 35.52 is added to read as follows:
Sec. 35.52 Possession, use, calibration, and check of instruments to
measure dosages of alpha- or beta-emitting radionuclides.
(a) This section does not apply to unit dosages of alpha- or beta-
emitting radionuclides that are obtained from a manufacturer or
preparer licensed pursuant to 10 CFR 32.72 or equivalent Agreement
State requirements.
(b) For other than unit dosages obtained pursuant to paragraph (a)
of this section, a licensee shall possess and use instrumentation to
measure the radioactivity of alpha- or beta-emitting radionuclides. The
licensee shall have procedures for use of the instrumentation. The
licensee shall measure, by direct measurement or by combination of
measurements and calculations, the amount of radioactivity in dosages
of alpha- or beta-emitting radionuclides prior to administration to
each patient or human research subject. In addition, the licensee
shall:
(1) Perform tests before initial use, periodically, and following
repair, on each instrument for accuracy, linearity, and geometry
dependence, as appropriate for the use of the instrument; and make
adjustments when necessary; and
(2) Check each instrument for constancy and proper operation at the
beginning of each day of use.
28. In Sec. 35.53, the section heading and paragraphs (a), (b),
(c)(2), and (c)(3) are revised as follows:
Sec. 35.53 Measurement of dosages of unsealed byproduct material for
medical use.
* * * * *
(a) Measure the activity of each dosage of a photon-emitting
radionuclide prior to medical use.
(b) Measure, by direct measurement or by combination of
measurements and calculations, the activity of each dosage of an alpha-
or a beta-emitting radionuclide prior to medical use, except for unit
dosages obtained from a manufacturer or preparer licensed pursuant to
10 CFR 32.72 or equivalent Agreement State requirements;
(c) * * *
(2) Patient's or human research subject's name, and identification
number if one has been assigned;
(3) Prescribed dosage and activity of the dosage at the time of
measurement, or a notation that the total activity is less than 1.1
megabecquerels (30 microcuries);
* * * * *
29. In Sec. 35.60, paragraphs (b) and (c) are revised to read as
follows:
Sec. 35.60 Syringe shields and labels.
* * * * *
(b) To identify its contents, a licensee shall conspicuously label
each syringe or syringe radiation shield that contains a syringe with a
radiopharmaceutical. The label must show the radiopharmaceutical name
or its abbreviation, the clinical procedure to be performed, or the
patient's or the human research subject's name.
(c) A licensee shall require each individual who prepares a
radiopharmaceutical kit to use a syringe radiation shield when
preparing the kit and shall require each individual to use a syringe
radiation shield when administering a radiopharmaceutical by injection
unless the use of the shield is contraindicated for that patient or
human research subject.
30. Section 35.75 is revised to read as follows:
Sec. 35.75 Release of patients or human research subjects containing
radiopharmaceuticals or permanent implants.
(a) A licensee may not authorize release from confinement for
medical care any patient or human research subject administered a
radiopharmaceutical until either:
(1) The measured dose rate from the patient or the human research
subject is less than 5 millirems per hour at a distance of 1 meter; or
(2) The activity in the patient or the human research subject is
less than 30 millicuries.
(b) A licensee may not authorize release from confinement for
medical care of any patient or human research subject administered a
permanent implant until the measured dose rate from the patient or the
human research subject is less than 5 millirems per hour at a distance
of 1 meter.
31. Section 35.100 is revised to read as follows:
Sec. 35.100 Use of unsealed byproduct material for uptake, dilution,
and excretion studies.
A licensee may use for uptake, dilution, or excretion studies any
unsealed byproduct material prepared for medical use that is either:
(a) Obtained from a manufacturer or preparer licensed pursuant to
10 CFR 32.72 or equivalent Agreement State requirements; or
(b) Prepared by an authorized nuclear pharmacist, a physician who
is an authorized user and who meets the requirements specified in
Sec. 35.920, or an individual under the supervision of either as
specified in Sec. 35.25.
32. Section 35.200 is revised to read as follows:
Sec. 35.200 Use of unsealed byproduct material for imaging and
localization studies.
A licensee may use for imaging and localization studies any
unsealed byproduct material prepared for medical use that is either:
(a) Obtained from a manufacturer or preparer licensed pursuant to
10 CFR 32.72 or equivalent Agreement State requirements; or
(b) Prepared by an authorized nuclear pharmacist, a physician who
is an authorized user and who meets the requirements specified in
Sec. 35.920, or an individual under the supervision of either as
specified in Sec. 35.25.
33. Section 35.300 is revised to read as follows:
Sec. 35.300 Use of unsealed byproduct material for therapeutic
administration.
A licensee may use for therapeutic administration any unsealed
byproduct material prepared for medical use that is either:
(a) Obtained from a manufacturer or preparer licensed pursuant to
10 CFR 32.72 or equivalent Agreement State requirements; or
(b) Prepared by an authorized nuclear pharmacist, a physician who
is an authorized user and who meets the requirements specified in
Sec. 35.920, or an individual under the supervision of either as
specified in Sec. 35.25.
34. In Sec. 35.310, the introductory text of paragraph (a), and
paragraphs (a)(1) and (a)(5) are revised to read as follows:
Sec. 35.310 Safety instruction.
(a) A licensee shall provide radiation safety instruction for all
personnel caring for the patient or the human research subject
receiving radiopharmaceutical therapy and hospitalized for compliance
with Sec. 35.75 of this chapter. To satisfy this requirement, the
instruction must describe the licensee's procedures for:
(1) Patient or human research subject control;
* * * * *
(5) Notification of the Radiation Safety Officer in case of the
patient's or the human research subject's death or medical emergency.
* * * * *
35. In Sec. 35.315, the introductory text of paragraph (a), and
paragraphs (a)(2), (a)(3), (a)(5), (a)(6), (a)(7), and (b) are revised
to read as follows:
Sec. 35.315 Safety precautions.
(a) For each patient or human research subject receiving
radiopharmaceutical therapy and hospitalized for compliance with
Sec. 35.75 of this chapter, a licensee shall:
* * * * *
(2) Post the patient's or the human research subject's door with a
``Radioactive Materials'' sign and note on the door or in the patient's
or human research subject's chart where and how long visitors may stay
in the patient's or the human research subject's room;
(3) Authorize visits by individuals under age 18 only on a case-by-
case basis with the approval of the authorized user after consultation
with the Radiation Safety Officer;
* * * * *
(5) Either monitor material and items removed from the patient's or
the human research subject's room to determine that their radioactivity
cannot be distinguished from the natural background radiation level
with a radiation detection survey instrument set on its most sensitive
scale and with no interposed shielding, or handle them as radioactive
waste.
(6) Provide the patient or the human research subject with
radiation safety guidance that will help to keep radiation dose to
household members and the public as low as reasonably achievable before
authorizing release of the patient or the human research subject.
(7) Survey the patient's or the human research subject's room and
private sanitary facility for removable contamination with a radiation
detection survey instrument before assigning another patient or human
research subject to the room. The room must not be reassigned until
removable contamination is less than 200 disintegrations per minute per
100 square centimeters; and
* * * * *
(b) A licensee shall notify the Radiation Safety Officer
immediately if the patient or the human research subject dies or has a
medical emergency.
36. Section 35.404 is revised to read as follows:
Sec. 35.404 Release of patients or human research subjects treated
with temporary implants.
(a) Immediately after removing the last temporary implant source
from a patient or a human research subject, the licensee shall make a
radiation survey of the patient or the human research subject with a
radiation detection survey instrument to confirm that all sources have
been removed. The licensee may not release from confinement for medical
care a patient or a human research subject treated by temporary implant
until all sources have been removed.
(b) A licensee shall retain a record of patient or human research
subject surveys for three years. Each record must include the date of
the survey, the name of the patient or the human research subject, the
dose rate from the patient or the human research subject expressed as
millirem per hour and measured at 1 meter from the patient or the human
research subject, the survey instrument used, and the initials of the
individual who made the survey.
37. In Sec. 35.406, paragraphs (a), (b), and (c) are revised to
read as follows:
Sec. 35.406 Brachytherapy sources inventory.
(a) Promptly after removing them from a patient or a human research
subject, a licensee shall return brachytherapy sources to the storage
area, and count the number returned to ensure that all sources taken
from the storage area have been returned.
(b) A licensee shall make a record of brachytherapy source use
which must include:
(1) The names of the individuals permitted to handle the sources;
(2) The number and activity of sources removed from storage, the
patient's or the human research subject's name and room number, the
time and date they were removed from storage, the number and activity
of the sources in storage after the removal, and the initials of the
individual who removed the sources from storage;
(3) The number and activity of sources returned to storage, the
patient's or the human research subject's name and room number, the
time and date they were returned to storage, the number and activity of
sources in storage after the return, and the initials of the individual
who returned the sources to storage.
(c) Immediately after implanting sources in a patient or a human
research subject the licensee shall make a radiation survey of the
patient or the human research subject and the area of use to confirm
that no sources have been misplaced. The licensee shall make a record
of each survey.
* * * * *
38. In Sec. 35.410, the introductory text of paragraph (a), and
paragraphs (a)(3) and (a)(5) are revised to read as follows:
Sec. 35.410 Safety instruction.
(a) The licensee shall provide radiation safety instruction to all
personnel caring for the patient or the human research subject
undergoing implant therapy. To satisfy this requirement, the
instruction must describe:
* * * * *
(3) Procedures for patient or human research subject control;
* * * * *
(5) Procedures for notification of the Radiation Safety Officer if
the patient or the human research subject dies or has a medical
emergency.
* * * * *
39. In Sec. 35.415, the introductory text of paragraph (a), and
paragraphs (a)(1), (a)(2), (a)(3), (a)(5) and (b) are revised to read
as follows:
Sec. 35.415 Safety precautions.
(a) For each patient or human research subject receiving implant
therapy, a licensee shall:
(1) Not quarter the patient or the human research subject in the
same room with an individual who is not receiving radiation therapy
unless the licensee can demonstrate compliance with the requirements of
Sec. 20.105(b) or, for licensees implementing the provisions of
Secs. 20.1001-20.2401, through Sec. 20.1301(a) of this chapter at a
distance of 1 meter from the implant;
(2) Post the patient's or human research subject's door with a
``Radioactive Materials'' sign and note on the door or in the patient's
or human research subject's chart where and how long visitors may stay
in the patient's or human research subject's room;
(3) Authorize visits by individuals under age 18 only on a case-by-
case basis with the approval of the authorized user after consultation
with the Radiation Safety Officer; and
* * * * *
(5) Provide the patient or the human research subject with
radiation safety guidance that will help to keep radiation dose to
household members and the public as low as reasonably achievable before
releasing the individual if the individual was administered a permanent
implant.
(b) A licensee shall notify the Radiation Safety Officer
immediately if the patient or the human research subject dies or has a
medical emergency.
40. In Sec. 35.610, paragraph (a)(1) is revised to read as follows:
Sec. 35.610 Safety instruction.
(a) * * *
(1) The procedure to be followed to ensure that only the patient or
the human research subject is in the treatment room before turning the
primary beam of radiation on to begin a treatment or after a door
interlock interruption;
* * * * *
41. In Sec. 35.615, paragraphs (d)(3) and (e) are revised to read
as follows:
Sec. 35.615 Safety precautions.
* * * * *
(d) * * *
(3) A radiation monitor must be checked with a dedicated check
source for proper operation each day before the teletherapy unit is
used for treatment of patients or human research subjects.
* * * * *
(e) A licensee shall construct or equip each teletherapy room to
permit continuous observation of the patient or the human research
subject from the teletherapy unit console during irradiation.
42. In Sec. 35.900, paragraphs (a)(4) and (a)(5) are revised and
paragraphs (a)(6) through (a)(9) are added to read as follows:
Sec. 35.900 Radiation Safety Officer.
* * * * *
(a) * * *
(4) American Board of Science in Nuclear Medicine;
(5) Board of Pharmaceutical Specialties in Nuclear Pharmacy;
(6) American Board of Medical Physics in radiation oncology
physics;
(7) Royal College of Physicians and Surgeons of Canada in nuclear
medicine;
(8) American Osteopathic Board of Radiology; or
(9) American Osteopathic Board of Nuclear Medicine; or
* * * * *
43. In Sec. 35.910, paragraph (a)(3) is revised, paragraphs (a)(4)
and (a)(5) are added, and paragraphs (b)(2)(i), (b)(2)(iii), and
(b)(2)(v) are revised to read as follows:
Sec. 35.910 Training for uptake, dilution, and excretion studies.
* * * * *
(a) * * *
(3) Diagnostic radiology or radiology by the American Osteopathic
Board of Radiology;
(4) Nuclear medicine by the Royal College of Physicians and
Surgeons of Canada; or
(5) American Osteopathic Board of Nuclear Medicine in nuclear
medicine; or
(b) * * *
(2) * * *
(i) Examining patients or human research subjects and reviewing
their case histories to determine their suitability for radioisotope
diagnosis, limitations, or contraindications;
* * * * *
(iii) Administering dosages to patients or human research subjects
and using syringe radiation shields;
* * * * *
(v) Patient or human research subject followup; or
* * * * *
44. In Sec. 35.920, paragraphs (a)(2) and (a)(3) are revised,
paragraphs (a)(4) and (a)(5) are added, and paragraphs (b)(2)(iii),
(b)(3)(i), (b)(3)(iii), and (b)(3)(v) are revised to read as follows:
Sec. 35.920 Training for imaging and localization studies.
* * * * *
(a) * * *
(2) Diagnostic radiology by the American Board of Radiology;
(3) Diagnostic radiology or radiology by the American Osteopathic
Board of Radiology;
(4) Nuclear medicine by the Royal College of Physicians and
Surgeons of Canada; or
(5) American Osteopathic Board of Nuclear Medicine in nuclear
medicine; or
(b) * * *
(2) * * *
(iii) Calculating and safely preparing patient or human research
subject dosages;
* * * * *
(3) * * *
(i) Examining patients or human research subjects and reviewing
their case histories to determine their suitability for radioisotope
diagnosis, limitations, or contraindications;
* * * * *
(iii) Administering dosages to patients or human research subjects
and using syringe radiation shields;
* * * * *
(v) Patient or human research subject followup; or
* * * * *
45. In Sec. 35.930, the section heading and paragraphs (a)(1) and
(a)(2) are revised and paragraphs (a)(3) and (a)(4) are added to read
as follows:
Sec. 35.930 Training for therapeutic use of unsealed byproduct
material.
* * * * *
(a) * * *
(1) The American Board of Nuclear Medicine;
(2) The American Board of Radiology in radiology, therapeutic
radiology, or radiation oncology;
(3) Nuclear medicine by the Royal College of Physicians and
Surgeons of Canada; or
(4) The American Osteopathic Board of Radiology after 1984; or
* * * * *
46. In Sec. 35.940, paragraph (a)(1) is revised to read as follows:
Sec. 35.940 Training for use of brachytherapy sources.
* * * * *
(a) * * *
(1) Radiology, therapeutic radiology, or radiation oncology by the
American Board of Radiology;
* * * * *
47. In Sec. 35.950, paragraphs (a)(1) and (a)(2) are revised and
paragraph (a)(4) is added to read as follows:
Sec. 35.950 Training for use of sealed sources for diagnosis.
* * * * *
(a) * * *
(1) Radiology, diagnostic radiology, therapeutic radiology, or
radiation oncology by the American Board of Radiology;
(2) Nuclear medicine by the American Board of Nuclear Medicine;
* * * * *
(4) Nuclear medicine by the Royal College of Physicians and
Surgeons of Canada; or
* * * * *
48. In Sec. 35.960, paragraphs (a)(1) and (b)(3)(iii) are revised
to read as follows:
Sec. 35.960 Training for teletherapy.
* * * * *
(a) * * *
(1) Radiology, therapeutic radiology, or radiation oncology by the
American Board of Radiology;
* * * * *
(b) * * *
(3) * * *
(iii) Calculating the teletherapy doses and collaborating with the
authorized user in the review of patients' or human research subjects'
progress and consideration of the need to modify originally prescribed
doses as warranted by patients' or human research subjects' reaction to
radiation; and
* * * * *
49. In Sec. 35.961, paragraph (b) is redesignated as paragraph (c)
and a new paragraph (b) is added to read as follows:
Sec. 35.961 Training for teletherapy physicist.
* * * * *
(b) Is certified by the American Board of Medical Physics in
radiation oncology physics; or
* * * * *
50. Section 35.972 is revised to read as follows:
Sec. 35.972 Recentness of training.
The training and experience specified in this subpart must have
been obtained within the 7 years preceding the date of application or
the individual must have had related continuing education and
experience since the required training and experience was completed.
51. Section 35.980 is added to read as follows:
Sec. 35.980 Training for an authorized nuclear pharmacist.
The licensee shall require the authorized nuclear pharmacist to be
a pharmacist who:
(a) Has current board certification as a nuclear pharmacist by the
Board of Pharmaceutical Specialties, or
(b)(1) Has completed 700 hours in a structured educational program
consisting of both:
(i) Didactic training in the following areas:
(A) Radiation physics and instrumentation;
(B) Radiation protection;
(C) Mathematics pertaining to the use and measurement of
radioactivity;
(D) Chemistry of byproduct material for medical use; and
(E) Radiation biology; and
(ii) Supervised experience in a nuclear pharmacy involving the
following:
(A) Shipping, receiving, and performing related radiation surveys;
(B) Using and performing checks for proper operation of dose
calibrators, survey meters, and, if appropriate, instruments used to
measure alpha- or beta-emitting radionuclides;
(C) Calculating, assaying, and safely preparing dosages for
patients or human research subjects;
(D) Using administrative controls to avoid mistakes in the
administration of byproduct material;
(E) Using procedures to prevent or minimize contamination and using
proper decontamination procedures; and
(2) Has obtained written certification, signed by a preceptor
authorized nuclear pharmacist, that the above training has been
satisfactorily completed and that the individual has achieved a level
of competency sufficient to independently operate a nuclear pharmacy.
52. Section 35.981 is added to read as follows:
Sec. 35.981 Training for experienced nuclear pharmacists.
A licensee may apply for and must receive a license amendment
identifying an experienced nuclear pharmacist as an authorized nuclear
pharmacist before it allows this individual to work as an authorized
nuclear pharmacist. A pharmacist who has completed a structured
educational program as specified in Sec. 35.980(b)(1) before (the date
of publication in the Federal Register) and who is working in a nuclear
pharmacy would qualify as an experienced nuclear pharmacist. An
experienced nuclear pharmacist need not comply with the requirements on
preceptor statement (Sec. 35.980(b)(2)) and recentness of training
(Sec. 35.972) to qualify as an authorized nuclear pharmacist.
53. In Sec. 35.991, paragraph (b) is revised to read as follows:
Sec. 35.991 Criminal penalties.
* * * * *
(b) The regulations in Part 35 that are not issued under
subsections 161b, 161i, or 161o for the purposes of section 223 are as
follows: Secs. 35.1, 35.2, 35.7, 35.8, 35.12, 35.15, 35.18, 35.19,
35.57, 35.100, 35.600, 35.901, 35.970, 35.971, 35.990, 35.991, and
35.999.
Dated at Rockville, Maryland, this 25th day of November, 1994.
For the Nuclear Regulatory Commission.
John C. Hoyle
Acting Secretary of the Commission.
[FR Doc. 94-29525 Filed 12-1-94; 8:45 am]
BILLING CODE 7590-01-P
