[Federal Register: January 8, 1999 (Volume 64, Number 5)]
[Notices]
[Page 1207-1208]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08ja99-77]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 92D-0077]


Compliance Policy Guide, Section 460.200 (CPG 7132.16); Rescinded

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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[[Page 1208]]

SUMMARY: The Food and Drug Administration (FDA) is announcing the
rescission of Compliance Policy Guide (CPG), section 460.200 (formerly
CPG 7132.16) entitled ``Manufacture, Distribution, and Promotion of
Adulterated, Misbranded, or Unapproved New Drugs for Human Use by
State-Licensed Pharmacies.'' CPG 7132.16 no longer reflects current
agency enforcement policy consistent with the provisions of section 127
of the Food and Drug Administration Modernization Act of 1997 (FDAMA).

FOR FURTHER INFORMATION CONTACT: Fred Richman, Center for Drug
Evaluation and Research (HFD-332), Food and Drug Administration, 7520
Standish Pl., Rockville, MD 20855-2737, 301-872-7292.

SUPPLEMENTARY INFORMATION: FDA is announcing the rescission of CPG,
section 460.200 (formerly CPG 7132.16) entitled ``Manufacture,
Distribution, and Promotion of Adulterated, Misbranded, or Unapproved
New Drugs for Human Use by State-Licensed Pharmacies.'' CPG 7132.16 no
longer reflects current agency enforcement policy consistent with the
provisions of section 127 of FDAMA.
    FDAMA adds section 503A to the Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 353a) to describe circumstances under which
compounded drugs are exempt from certain adulteration, misbranding, and
new drug requirements of the act. To gain these exemptions, compounded
drug products are generally prepared by a licensed pharmacist or
licensed physician for individual patients because the products are not
available commercially. FDA is developing regulations and guidance on
this subject.

    Dated: January 4, 1999.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 99-382 Filed 1-7-99; 8:45 am]
BILLING CODE 4160-01-F