On December 27, 2023, the FDA released a revised draft version of its October 2023 guidance titled Quality Considerations for Topical Ophthalmic Drug Products: Guidance for Industry. This revised draft, of the same name, outlines most of what was covered in the October draft guidance; however, it does include some clarifications and some additional information. The […]
Last week, the FDA has announced the availability of two draft Guidances for Industry regarding compounding of human drugs: Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act (here); and Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and […]
On the heels of additional reports of methanol poisoning from ingestion of hand sanitizers, the FDA issued a new final guidance titled Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol (here) for immediate implementation. The guidance applies to the use of pharmaceutical alcohols (PAs) (ethanol and isopropyl alcohol) by pharmaceutical manufacturers, outsourcing […]
In a recent issue of a veterinary journal, vaccines for bees (for American Foul Brood – AFB) made the headlines. Veterinarians would oversee administering the vaccine and possibly in “compounding” the vaccine for specific queen bees. Honeybees are food animals because they produce honey for human consumption and because they have a role in crop […]
For those struggling with understanding all the complexities of running a 503B compounding facility, a new resource is now available. The International Society of Pharmaceutical Engineers (ISPE) has a new guide coming out titled “503B Compounding – Regulatory Basis and Industry Good Practices for Outsourcing Facilities” (here). Do you know why compounding exists? Shouldn’t all […]
In a Federal Register Notice, FDA explains that ephedrine sulfate and hydroxychloroquine sulfate are not to be included on the bulk drug list for use in compounding by 503B outsourcing facilities (here). As mentioned by the Agency “[O]ne of the conditions that must be met for a drug product compounded by an outsourcing facility to […]
The Food and Drug Administration (FDA) has announced the fiscal year (FY) 2024 rates for the establishment and reinspection fees related to entities (503B registered facilities)” that compound human drugs and elect to register as outsourcing facilities under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FD&C Act authorizes FDA to assess and […]
The FDA released a guidance yesterday titled Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act (here), which (as its title suggests) fully outlines what the Agency does and does not consider wholesaling by an outsourcing facility. The examples of what a firm can and cannot do under the provisions of […]
The 503B outsourcing facilities are able to compound drug products in certain circumstances using bulk ingredients but “[O]ne of the conditions that must be met for a drug product compounded by an outsourcing facility to qualify for the exemptions under section 503B of the FD&C Act is that the outsourcing facility may not compound a […]
With the United States currently experiencing shortages of Ibuprofen suspension due to an increased demand that the FDA states is caused by “a surge in three viruses: Coronavirus Disease 2019 (COVID-19), respiratory syncytial virus (RSV), and influenza,” the Agency recognizes the need to establish an appropriate enforcement strategy to aid in the availability of this […]
