Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of Human Drug Compounding Outsourcing Facilities Under the Federal Food, Drug, and Cosmetic Act and Associated Fees
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (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 the information collection pertaining to the registration of human drug compounding outsourcing facilities under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and associated fees.
Read the official notice →Source: Federal Register (FDA/USDA food labeling) · US Government work (public domain). This is a short, attributed summary; the full authoritative text lives on the authority’s own site. LabelYog does not author or endorse it — confirm compliance against the destination market’s official source.
More from United States
- National Wildlife Refuge System; 2026-2027 Station-Specific Hunting and Sport Fishing Regulations regulatory
- Pharmacokinetics in Patients With Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosage; Draft Guidance for Industry; Availability regulatory
- Dental Composite Resin Devices and Dental Curing Lights-Premarket Notification (510(k)) Submissions Guidances; Guidances for Industry and Food and Drug Administration Staff; Availability regulatory
- Notice of Request To Renew an Approved Information Collection: Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery regulatory
- International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Studies To Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing (Revision 2); Guidance for Industry; Availability regulatory
- International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Studies To Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Reproduction Testing (Revision 1); Guidance for Industry; Availability regulatory
What this means for your label
A notice like this changes what a pack must carry. These are the rules we build against, starting with US FDA.