[Federal Register Volume 64, Number 83 (Friday, April 30, 1999)]
[Notices]
[Pages 23340-23341]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-10798]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99N-0872]


Revocation of Office of Generic Drug's Interim Policy Statement 
on Inactive Ingredients

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is revoking an interim 
policy statement on inactive ingredients in parenteral, ophthalmic, 
otic, and topical generic drug products (Interim Inactive Ingredient 
Policy). These generic drug products are the subjects of abbreviated 
new drug applications (ANDA's). The Interim Inactive Ingredient Policy 
was issued as a memorandum from the Acting Director of the Center for 
Drug Evaluation and Research's (CDER's) Office of Generic Drugs, FDA, 
to CDER's Associate Director for Science and Medical Affairs, FDA. FDA 
is taking this action because the Interim Inactive Ingredient Policy no 
longer represents current agency policy.

EFFECTIVE DATE: April 30, 1999.
ADDRESSES:
    Address questions about individual applications to the Regulatory 
Support Branch, Center for Drug Evaluation and Research (HFD-615), Food 
and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-
827-5862.
    Address questions about the use of inactive ingredients in a drug 
product for which you plan to submit an ANDA to the Office of Generic 
Drugs, Center for Drug Evaluation and Research (HFD-600), Food and Drug 
Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-5845.

 FOR FURTHER INFORMATION CONTACT: Rita R. Hassall, Office of Generic 
Drugs (HFD-600), Center for Drug Evaluation and Research, Food and Drug 
Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-5845.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term 
Restoration Act of 1984 (Pub. L. No. 98-417) (the Hatch-Waxman 
Amendments) established procedures for approval of ANDA's for drug 
products that are generic versions of previously approved drug 
products. In the Federal Register of April 28, 1992 (57 FR 17950), FDA

[[Page 23341]]

published regulations implementing provisions of the Hatch-Waxman 
Amendments. After publication of these regulations, FDA's Office of 
Generic Drugs issued the Interim Inactive Ingredient Policy on November 
17, 1994, to provide additional guidance on inactive ingredients in 
drug products that were the subjects of ANDA's. (This policy statement 
was issued as a memorandum and was not published in the Federal 
Register.)
    After 4 years of experience and new considerations raised by both 
the agency and regulated industry, FDA has concluded that the policies 
contained in the Interim Inactive Ingredient Policy no longer represent 
current agency thinking on many of the issues discussed in the 
document. Therefore, FDA has decided to revoke the Interim Inactive 
Ingredient Policy.
    The Office of Generic Drugs is developing a draft guidance 
regarding inactive ingredients in drug products that are the subject of 
ANDA's. This guidance will be issued under FDA's good guidance 
practices described in a notice published in the Federal Register of 
February 27, 1997 (62 FR 8961). Until the guidance is issued, 
applicants who have questions about the use of inactive ingredients in 
a drug product for which they plan to submit an ANDA should contact the 
Office of Generic Drugs (address above).

    Dated: April 23, 1999.
William K. Hubbard,
Acting Deputy Commissioner for Policy.
[FR Doc. 99-10798 Filed 4-29-99; 8:45 am]
BILLING CODE 4160-01-F