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 […]
Outsourcing compounding facilities are those that register with the FDA as such under section 503B of the Federal Food Drug and Cosmetic Act. According to the FDA, “[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 […]
For those facilities compounding drug products and distributing them out of state, the FDA has extended the statutory enforcement date. On the Federal Register prepublication page this morning, the Agency announced that it is “extending the period before FDA intends to begin enforcing the statutory 5 percent limit on distribution of compounded human drug products […]
Yesterday, the FDA published a web page entitled, Mitigating Risks of Compounded Drugs Through Surveillance (here) which provides an overview of FDA’s Compounding Incidents Program. It discusses how the program works in evaluating reports of adverse events and a broad range of drug product quality complaints and what the outcomes can occur based on the […]
The FDA’s Pharmacy Compounding Advisory Committee will be considering the addition of four new ingredients for use for inclusion on the bulk list for 503A compounders to utilize in the compounding of prescription drug products. The four ingredients up for consideration are: Ammonium tetrathiomolybdate; Enclomiphene citrate; Ferric subsulfate; and Glutathione The Notice for the Advisory […]
