Department of Health and Human Services May 31, 2005 – Federal Register Recent Federal Regulation Documents
Results 1 - 19 of 19
Agency Information Collection Activities; Proposed Collection; Comment Request; Regulations Under the Federal Import Milk Act
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on reporting and recordkeeping requirements in implementing the Federal Import Milk Act (FIMA).
Draft Guidance on Expiration Dating of Unit-Dose Repackaged Drugs; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Expiration Dating of Unit- Dose Repackaged Drugs.'' The draft guidance is a proposed revision of section 480.200 of FDA's Compliance Policy Guide (CPG) (CPG 7132b.11). We are proposing to revise CPG 7132b.11 so that FDA enforcement policy regarding expiration dating of nonsterile unit-dose repackaged drugs under the agency's current good manufacturing practice (CGMP) regulations is substantially comparable to the expiration dating standards for such drugs set forth in the U.S. Pharmacopeia (USP).
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