Bulk Drug Substances To Be Used in Pharmacy Compounding; Request for Nominations

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