[Federal Register: April 30, 1999 (Volume 64, Number 83)]
[Notices]
[Page 23340-23341]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30ap99-100]

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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is taking this action because the Interim Inactive Ingredient Policy no
longer represents current agency policy.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