[Federal Register: November 23, 1998 (Volume 63, Number 225)]
[Notices]               
[Page 64723-64724]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23no98-116]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98D-1008]

 
Guidance for Industry on Enforcement Policy During Implementation 
of Section 503A of the Federal Food, Drug, and Cosmetic Act; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry entitled ``Enforcement Policy 
During Implementation of Section 503A of the Federal Food, Drug, and 
Cosmetic Act.'' This guidance document provides an overview of FDA's 
policy on enforcement of the pharmacy compounding provisions of section 
503A of the Federal Food, Drug, and Cosmetic Act (the act) during the 
transition to full implementation of that section, which was added by 
the Food and Drug Administration Modernization Act of 1997 (the 
Modernization Act).

DATES: Written comments on the guidance document may be submitted by 
February 22, 1999. General comments on agency guidance documents are 
welcome at any time.

ADDRESSES: Submit written requests for single copies of the guidance 
document to the Drug Information Branch (HFD-210), Center for Drug 
Evaluation and Research, Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857. Send one self-addressed adhesive label to 
assist that office in processing your requests. Submit written comments 
to the Dockets Management Branch (HFD-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Requests and comments should be identified with the docket number found 
in brackets in the heading of this document. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Lee D. Korb, Center for Drug 
Evaluation and Research (HFD-7), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-2041.

SUPPLEMENTARY INFORMATION:

I. Background

     FDA is announcing the availability of a guidance for industry 
entitled ``Enforcement Policy During Implementation of Section 503A of 
the

[[Page 64724]]

Federal Food, Drug, and Cosmetic Act.'' On November 21, 1997, the 
President signed the Modernization Act (Pub. L. 105-115). 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. 
Under section 503A of the act, drug products that are compounded by a 
pharmacist or physician on a customized basis for an individual patient 
may be entitled to exemptions from three key provisions of the act: (1) 
The adulteration provision of section 501(a)(2)(B) (21 U.S.C. 
351(a)(2)(B)) (concerning the good manufacturing practice 
requirements), (2) the misbranding provision of section 502(f)(1) (21 
U.S.C. 352(f)(1)) (concerning the labeling of drugs with adequate 
directions for use), and (3) the new drug provision of section 505 (21 
U.S.C. 355) (concerning the approval of drugs under new drug or 
abbreviated new drug applications).
    To qualify for these statutory exemptions, a compounded drug 
product must satisfy several requirements, some of which are to be the 
subject of FDA's rulemaking or other actions. FDA is currently working 
on several rules and other documents necessary to implement section 
503A of the act. However, section 503A of the act takes effect on 
November 21, 1998, and FDA will not have completed its implementation 
efforts by this date. This guidance document describes FDA's policy on 
enforcement of section 503A of the act during the transition to full 
implementation of that provision.
    This guidance document is being issued as a Level 1 guidance 
consistent with FDA's ``Good Guidance Practices'' (62 FR 8961, February 
27, 1997). It is being implemented immediately without prior public 
comment because the guidance document is needed to explain to industry 
the agency's current policy on enforcement of section 503A of the act, 
which will take effect November 21, 1998. However, the agency wishes to 
solicit comment from the public and is providing a 90-day comment 
period and establishing a docket for the receipt of comments.
    This guidance document represents the agency's current thinking on 
enforcement of section 503A of the act during the transition to full 
implementation. It does not create or confer any rights for or on any 
person and does not operate to bind FDA or the public. An alternative 
approach may be used if such approach satisfies the requirements of the 
applicable statute, regulations, or both.

II. Comments

    Interested persons may, on or before February 22, 1999, submit to 
the Dockets Management Branch (address above) written comments on the 
guidance document. 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. The guidance document and received comments may be seen 
in the office above between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the document using 
the World Wide Web (WWW). For WWW access, connect to CDER at ``http://
www.fda.gov/cder/guidance.htm''.

    Dated: November 17, 1998.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 98-31221 Filed 11-20-98; 8:45 am]
BILLING CODE 4160-01-F