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

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.

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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]

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