[Federal Register Volume 63, Number 66 (Tuesday, April 7, 1998)]
[Notices]
[Pages 17011-17012]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-9037]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98N-0182]
Bulk Drug Substances To Be Used in Pharmacy Compounding; Request
for Nominations
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for nominations.
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SUMMARY: The Food and Drug Administration (FDA) is preparing to develop
a list of bulk drug substances (bulk drugs) that may be used in
pharmacy compounding that do not have a United States Pharmacopeia
(USP) or National Formulary (NF) monograph and are not components of
approved drugs. FDA is taking this action in accordance with provisions
in the Food and Drug Administration Modernization Act of 1997 (FDAMA).
To identify candidates for this bulk drugs list, FDA is encouraging
interested groups and individuals to nominate specific bulk drug
substances and is describing the information that should be provided to
the agency in support of each nomination.
DATES: Nominations must be received by June 8, 1998, to receive
consideration for inclusion on the bulk drugs list. Nominations
received after this date will receive consideration for subsequent
amendments to the list.
ADDRESSES: Send nominations to the Dockets Management Branch (HFA-305),
Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville,
MD 20857.
FOR FURTHER INFORMATION CONTACT: Robert J. Tonelli, Center for Drug
Evaluation and Research (HFD-332), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-0101.
SUPPLEMENTARY INFORMATION: President Clinton signed FDAMA (Pub. L. 105-
115) into law on November 21, 1997. One of the issues addressed in this
new legislation is the applicability of the Federal Food, Drug, and
Cosmetic Act (the act) to the practice of pharmacy compounding.
Compounding involves a process whereby a pharmacist or physician
combines, mixes, or alters ingredients to create a customized
medication for an individual patient. Section 127 of FDAMA, which adds
section 503A to the act (21 U.S.C. 353a), describes the circumstances
under which compounded drugs qualify for exemptions from certain
adulteration, misbranding, and new drug provisions of the act. Section
127 becomes effective 1 year from the date of the FDAMA's enactment
(section 503A(b) of the act).
Section 127 contains several restrictions regarding the bulk drug
substances\1\ that may be used as ingredients in compounding and still
qualify for the applicable exemptions. It provides, among other things,
that such substances must comply with the standards of an applicable
USP or NF monograph, if one exists, and the USP chapter on pharmacy
compounding; if a monograph does not exist, they must be components of
drugs approved by FDA; and if neither of those criteria are satisfied,
they must appear on a list that FDA develops and issues through
regulations (section 503A(b)(1)(A)(i)(I) through (b)(1)(A)(i)(III) of
the act).
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\1\ The term ``bulk drug substance'' is defined in FDA's
regulations at 21 CFR 207.3(a)(4) and incorporated in section 127 of
FDAMA to mean ``any substance that is represented for use in a drug
and that, when used in the manufacturing, processing, or packaging
of a drug, becomes an active ingredient or finished dosage form of
the drug, but the term does not include intermediates used in the
synthesis of such substances.''
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In accordance with the bulk drug provisions in section 127, FDA is
preparing to develop a list of bulk drug substances that may be used in
compounding that do not have a USP or NF monograph and are not
components of approved drugs. To identify candidates for this list, FDA
is seeking public input in the form of specific bulk drug nominations.
All interested groups and individuals are encouraged to nominate
specific bulk drug substances for inclusion on the list. FDA intends
for this nomination process to serve as its principal means of
identifying list candidates. After evaluating the nominations and, as
required by Congress, consulting with the United States Pharmacopeial
Convention, Inc., and an advisory committee on compounding (section
503A(d) of the act), FDA will issue the list as a regulation under
notice-and-comment rulemaking procedures.
Nominations should include the following information about the bulk
drug substance being nominated and the product(s) that will be
compounded using such substance. If the information requested is
unknown or unavailable, that fact should be noted accordingly.
Bulk Drug Substance
Ingredient name;
Chemical name;
Common name(s);
Chemical grade or description of the strength, quality,
and purity of the ingredient;
Information about how the ingredient is supplied (e.g.,
powder, liquid);
Information about recognition of the substance in foreign
pharmacopeias and the status of its registration(s) in other countries,
including whether information has been submitted to USP for
consideration of monograph development; and
A bibliography of available safety and efficacy data \2\,
including any
[[Page 17012]]
relevant peer reviewed medical literature.
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\2\ FDA recognizes that the available safety and efficacy data
is unlikely to be of the same type, amount, or quality as would be
required to support a new drug application, but this fact will not
preclude a bulk drug substance from consideration for inclusion on
the list.
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Compounded Product
Information about the dosage form(s) into which the drug
substance will be compounded (including formulations);
Information about the strength(s) of the compounded
product(s);
Information about the anticipated route(s) of
administration of the compounded product(s);
Information about the past and proposed use(s) of the
compounded product(s), including the rationale for its use or why the
compounded product(s), as opposed to a commercially available product,
is necessary;
Available stability data for the compounded product(s);
and
Additional relevant information.
FDA cannot guarantee that all drugs nominated during the comment
period will be considered for inclusion on the first published bulk
drugs list. Nominations received during the comment period that are
supported by the most complete and relevant information, as set forth
previously, will likely be evaluated first. Nominations that are not
evaluated during this first phase will receive consideration for list
amendments, as the development and issuance of this list will be an
ongoing process. Individuals and organizations also will be able to
petition FDA to make additional list amendments after the list is
published.
Interested groups and individuals should submit their bulk drug
substance nominations to the Dockets Management Branch (address above).
Two copies of the nominations are to be submitted, except that
individuals may submit one copy. However, individuals are encouraged to
consolidate their submissions through professional organizations.
Nominations are to be identified with the docket number found in
brackets in the heading of this document. Received nominations and
supporting information will be treated as public information and will
be available for inspection at the above address between 9 a.m. and 4
p.m., Monday through Friday.
Dated: April 1, 1998.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 98-9037 Filed 4-6-98; 8:45 am]
BILLING CODE 4160-01-F
