[Federal Register Volume 63, Number 200 (Friday, October 16, 1998)]
[Proposed Rules]
[Page 55564]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-27814]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 216

[Docket No. 98N-0182]


List of Bulk Drug Substances That May Be Used in Pharmacy 
Compounding; Preliminary Draft Proposed Rule; Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION: Availability of preliminary draft proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing 
regulations identifying the bulk drug substances that may be used in 
pharmacy compounding under the exemptions provided by the Federal Food, 
Drug, and Cosmetic Act (the act) even though they are neither the 
subject of a current United States Pharmacopeia (USP) or National 
Formulary (NF) monograph nor a component of an FDA approved drug. FDA's 
development and publication of this bulk drug list is required by the 
Food and Drug Administration Modernization Act of 1997 (Modernization 
Act). This preliminary draft of the proposed rule is being made 
available to allow full discussion of its contents at the Pharmacy 
Compounding Advisory Committee meeting to be held on October 14, 15, 
and 16, 1998. FDA is requesting comments concerning the preliminary 
draft of the proposed rule.

DATES:  Submit written comments on or before October 30, 1998.

ADDRESSES:  A copy of the preliminary draft proposed rule will be on 
display at the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Submit requests for copies of the preliminary draft proposed rule from 
the Drug Information Branch (HFD-210), Food and Drug Administration, 
5600 Fishers Lane, Rockville, MD 20857, 301-827-4573, and the Center 
for Drug Evaluation and Research's Fax-on-Demand system at 301-827-0577 
or 800-342-2722. An electronic version of the preliminary draft 
proposed rule is available via the Internet at ``http://www.fda.gov/
cder/fdama'' under the subject ``Pharmacy Compounding.''
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, 301-827-7295.

SUPPLEMENTARY INFORMATION:

I. Background

    On November 21, 1997, the President signed the Modernization Act 
(Pub. L. 105-115) into law. Section 127 of the Modernization Act, which 
adds section 503A to the act (21 U.S.C. 353a), clarifies the status of 
pharmacy compounding under Federal law.
    Section 503A(d)(1) of the the act requires that, unless good cause 
is shown, FDA convene and consult with an advisory committee on 
compounding before issuing regulations listing bulk drug substances 
that may be used in pharmacy compounding. The Pharmacy Compounding 
Advisory Committee was established by a final rule published in the 
Federal Register of March 10, 1998 (63 FR 11596). A meeting of the 
advisory committee to discuss, among other things, the list of bulk 
drug substances that may be used in pharmacy compounding was announced 
in the Federal Register of September 4, 1998 (63 FR 47301). The meeting 
will be held on October 14, 15, and 16, 1998.
    Under 21 CFR 10.40(f)(4) and 10.80(b)(2), FDA has decided to make 
available to the public a preliminary draft proposed rule identifying 
the bulk drug substances that may be used in pharmacy compounding under 
the exemptions provided by the act even though they are neither the 
subject of a current USP or NF monograph nor a component of an FDA 
approved drug. This preliminary draft proposed rule is being made 
available to facilitate a full and open discussion at the advisory 
committee meeting of the list of bulk drug substances that may be used 
in pharmacy compounding.

II. Request for Comments

    Interested persons may, on or before October 30, 1998, submit to 
the Dockets Management Branch (address above) written comments 
regarding this preliminary draft proposed rule. Two copies of any 
comments are to be submitted, except that individuals may submit one 
copy. Comments are to be identified with the docket number found in 
brackets in the heading of this document. Received comments may be seen 
in the office above between 9 a.m. and 4 p.m., Monday through Friday.
    (Authority: 21 U.S.C. 321 et seq.)

    Dated: October 7, 1998.
 William K. Hubbard,
 Associate Commissioner for Policy Coordination.
[FR Doc. 98-27814 Filed 10-13-98; 2:28 pm]
BILLING CODE 4160-01-F