[Federal Register Volume 63, Number 225 (Monday, November 23, 1998)]
[Notices]
[Pages 64723-64724]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-31221]
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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]
BILLING CODE 4160-01-F