[Federal Register Volume 61, Number 124 (Wednesday, June 26, 1996)]
[Rules and Regulations]
[Pages 32925-32926]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-16299]
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DEPARTMENT OF THE TREASURY
Drug Enforcement Administration
21 CFR Parts 1309 and 1310
[DEA-133F]
RIN 1117-AA29
Waiver of Requirements for the Distribution of Prescription Drug
Products Drug Products That Contain List I Chemicals
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Final rule.
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SUMMARY: DEA is amending its regulations to waive the registration
requirement for persons who distribute prescription drug products that
are subject to regulation on List I chemicals and to allow that the
records required to be maintained pursuant to the Federal Food and Drug
Administration (FDA) regulations for prescription drug products shall
be deemed adequate for satisfying DEA's recordkeeping requirements with
respect to distribution. In response from industry, DEA has conducted a
review and determined that such prescription drug products are already
subject to extensive regulatory controls regarding their distribution
and there is no evidence that the products are being diverted at this
time. This action will relieve distributors and manufacturers of
regulated prescription drug products containing List I chemicals from
the chemical control requirements in circumstances where compliance
would be unnecessary for enforcement of the law.
EFFECTIVE DATE: July 26, 1996.
FOR FURTHER INFORMATION CONTACT:
G. Thomas Gitchel, Chief, Liaison and Policy Section, Office of
Diversion Control, Drug Enforcement Administration, Washington, DC
20537, Telephone (202) 307-7297.
SUPPLEMENTARY INFORMATION: On September 26, 1995, DEA published a
notice in the Federal Register (60 FR 49527) proposing to amend Title
21, Code of Federal Regulations (CFR), parts 1309 and 1310, to waive
the requirement of registration for persons distributing prescription
drug products that are regulated as List I chemicals and to allow that
the records required to be maintained pursuant to the FDA regulations
for prescription drug products shall be deemed adequate for satisfying
DEA's recordkeeping requirements with respect to distribution. This
rule responds industry's requests for relief based on existing
regulatory controls and the lack of evidence of diversion of the
products.
One comments was submitted in response to the proposed rulemaking.
That comment, while supporting the proposed amendments, requested that
DEA include in the regulations a provision that the FDA record
retention requirement of two years, rather that the four year retention
period required under the Controlled Substances Act (CSA), would apply
to records of distributions of regulated prescription drug products.
DEA is aware of the discrepancy between the record retention
requirements between the FDA and DEA for these products; however, DEA
does not have flexibility regarding the recordkeeping retention period
for List I chemicals since 21 U.S.C. 830(a)(1)(A) of the CSA mandates
that records of transactions involving List I chemicals shall be
maintained for four years. There is no provision in the CSA allowing
DEA the discretion to waive or modify that requirement. Only the
Congress could amend the statute as proposed by the commentor. Until
that requirement of the law is amended, records of regulated
transactions involving List I chemicals must be maintained for the
required four year period.
The Deputy Administrator of the Drug Enforcement Administration
hereby certifies that this rulemaking will not have a significant
impact on a large number of entities whose interests must be considered
under the Regulatory Flexibility Act, 5 U.S.C. 601 et seq. This
rulemaking grants those persons who distribute regulated prescription
drug products relief from DEA's chemical registration requirement and
allows for the use of records already maintained pursuant to FDA
regulations in lieu of requiring that separate records be maintained.
These amendments could potentially ease the regulatory burden for 1,200
or more distributors and manufacturers of regulated prescription drug
products.
This rule has been drafted and reviewed in accordance with
Executive Order 12866. DEA has determined that this is not a
significant regulatory action under the provisions of Executive Order
12866, section 3(f) and accordingly this rule has not been reviewed by
the Office of Management and Budget. This rule will eliminate
unnecessary regulatory requirements for distributors of regulated
prescription drug products.
This action has been analyzed in accordance with the principles an
criteria in Executive Order 12612, and it has been determined that the
rule does not have sufficient federalism
[[Page 32926]]
implications to warrant the preparation of a Federalism Assessment.
List of Subjects
21 CFR Part 1309
Administrative practice and procedure, Drug traffic control, List I
and List II chemicals, Security measures.
21 CFR Part 1310
Drug traffic control, List I and List II chemicals, Reporting and
recordkeeping requirements.
For reasons set out above, 21 CFR parts 1309, and 1310 are amended
as follows:
PART 1309--[AMENDED]
1. The authority citation for part 1309 continues to read as
follows:
Authority: 21 U.S.C. 821, 822, 823, 824, 830, 871(b), 875, 877,
958
2. Section 1309.21 is revised to read as follows:
Sec. 1309.21 Persons required to register.
(a) Every person who distributes, imports, or exports any List I
chemical, other than those List I chemicals contained in a product
exempted under Section 1310.01(f)(1)(iv) of this chapter, or who
proposes to engage in the distribution, importation, or exportation of
any List I chemical, shall obtain annually a registration specific to
the List I chemicals to be handled, unless exempted by law or pursuant
to Secs. 1309.24 through 1309.28 of this part. Only persons actually
engaged in such activities are required to obtain a registration;
related or affiliated persons who are not engaged in such activities
are not required to be registered. (For example, a stockholder or
parent corporation of a corporation distributing List I chemicals is
not required to obtain a registration.)
(b) Every person who distributes or exports a List I chemical they
have manufactured, other than a List I chemical contained in a product
exempted under Sec. 1310.01(f)(1)(iv) of this chapter, or proposes to
distribute or export a List I chemical they have manufactured, shall
obtain annually a registration specific to the List I chemicals to be
handled, unless exempted by law or pursuant to Secs. 1309.24 through
1309.28 of this part.
3. Section 1309.22 is amended by revising paragraph (b) to read as
follows:
Sec. 1309.22 Separate registration for independent activities.
* * * * *
(b) Every person who engages in more than one group of independent
activities shall obtain a separate registration for each group of
activities, unless otherwise exempted by the Act or Sections 1309.24
through 1309.28 of this part, except that a person registered to import
any List I chemical shall be authorized to distribute that List I
chemical after importation, but no other chemical that the person is
not registered to import.
4. Section 1309.28 is added to read as follows:
Sec. 1309.28 Exemption of distributors of regulated prescription drug
products.
(a) The requirement of registration is waived for any person who
distributes a prescription drug product containing a List I chemical
that is regulated pursuant to Sec. 1310.01(f)(1)(iv) of this chapter.
(b) If any person exempted by this section also engages in the
distribution, importation or exportation of a List I chemical, other
than as described in paragraph (a) of this section, the person shall
obtain a registration for such activities, as required by Sec. 1309.21
of this part.
(c) The Administrator may, upon finding that continuation of the
waiver granted in paragraph (a) of this section would not be in the
public interest, suspend or revoke a person's waiver pursuant to the
procedures set forth in Sec. Sec. 1309.43 through 1309.46 and 1309.51
through 1309.57 of this part.
PART 1310--[AMENDED]
5. The authority citation for part 1310 continues to read as
follows:
Authority: 21 U.S.C. 802, 830, 871(b)
6. Section 1310.06 is amended by revising paragraph (b) to read as
follows:
Sec. 1310.06 Content of records and reports.
* * * * *
(b) For purposes of this section, normal business records shall be
considered adequate if they contain the information listed in paragraph
(a) of this section and are readily retrievable from other business
records of the regulated person. For prescription drug products,
prescription and hospital records kept in the normal course of medical
treatment shall be considered adequate for satisfying the requirements
of paragraph (a) of this section with respect to dispensing to
patients, and records required to be maintained pursuant to the Federal
Food and Drug Administration regulations relating to the distribution
of prescription drugs, as set forth in 21 CFR part 205, shall be
considered adequate for satisfying the requirements of paragraph (a) of
this section with respect to distributions.
* * * * *
Dated: May 28, 1996.
Stephen H. Greene,
Deputy Administrator, Drug Enforcement Administration.
[FR Doc. 96-16299 Filed 6-25-96; 8:45 am]
BILLING CODE 4410-09-M
