Reports and guidance documents; availability, etc.: Inactive ingredients; Generic Drug Office's policy statement revocation,

[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]

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.

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 FDA is taking this action because the Interim Inactive Ingredient Policy no longer represents current agency policy.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. 99-10798Filed4-29-99; 8:45 am]

BILLING CODE 4160-01-F

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