Department of Health and Human Services December 7, 2023 – Federal Register Recent Federal Regulation Documents
Results 1 - 9 of 9
Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Interim Policy on Compounding Using Bulk Drug Substances Under section 503A of the Federal Food, Drug, and Cosmetic Act'' (draft guidance or 2023 503A Interim Policy Draft Guidance) to describe FDA's interim policy regarding the use of bulk drug substances by human drug compounders that are not registered with FDA as outsourcing facilities while FDA develops the list of bulk drug substances that can be used in compounding under the applicable section of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This draft guidance, when finalized, will replace the guidance for industry entitled, ``Interim Policy on Compounding Using Bulk Drug Substances under section 503A of the Federal Food, Drug, and Cosmetic Act'' issued in January 2017 (2017 503A Interim Policy Guidance).
Determination of Regulatory Review Period for Purposes of Patent Extension; Truseltiq
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for Truseltiq and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: The Alliance for Innovation on Maternal Health Biannual Survey, OMB No. 0915-xxxx-New
In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Medicare and Medicaid Programs; Application From the Joint Commission (TJC) for Initial Approval of Its Rural Health Clinic (RHC) Accreditation Program
This proposed notice acknowledges the receipt of an application from the Joint Commission (TJC) for initial recognition as a national accrediting organization (AO) for rural health clinics (RHCs) that wish to participate in the Medicare or Medicaid programs. The statute requires that within 60 days of receipt of an organization's complete application, the Centers for Medicare & Medicaid Services (CMS) publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.
Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs.'' The guidance addresses the verification systems that manufacturers, repackagers, wholesale distributors, and dispensers must have in place to comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Drug Supply Chain Security Act (DSCSA). Specifically, the guidance covers the statutory verification systems requirements that include the quarantine and investigation of a product determined to be suspect and the quarantine and disposition of a product determined to be illegitimate. The guidance also addresses the statutory requirement for notification to the Agency of a product that has been cleared by a manufacturer, repackager, wholesale distributor, or dispenser (also referred to as ``trading partners'') after a suspect product investigation because it is determined that the product is not an illegitimate product. Finally, the guidance addresses the statutory requirement for responding to requests for verification and processing saleable returns. The guidance finalizes the revised draft guidance ``Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs,'' issued on March 10, 2022.
Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Interim Policy on Compounding Using Bulk Drug Substances Under section 503B of the Federal Food, Drug, and Cosmetic Act'' (draft guidance or 2023 503B Interim Policy Draft Guidance) to describe FDA's interim policy regarding the use of bulk drug substances in compounding by outsourcing facilities while FDA develops the list of bulk drug substances that outsourcing facilities can use in compounding under the applicable section of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This draft guidance, when finalized, will replace the guidance for industry entitled, ``Interim Policy on Compounding Using Bulk Drug Substances Under section 503B of the Federal Food, Drug, and Cosmetic Act'' issued in January 2017 (2017 503B Interim Policy Guidance).
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