99-382. Compliance Policy Guide, Section 460.200 (CPG 7132.16); Rescinded

[Federal Register Volume 64, Number 5 (Friday, January 8, 1999)]
[Notices]
[Pages 1207-1208]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-382]


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Compliance Policy Guide, Section 460.200 (CPG 7132.16); Rescinded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