On 8/6/2021, a Federal Register Notice (here) was issued announcing an extension of the period before FDA intends to begin enforcing the statutory 5 percent limit on out of state distribution of compounded human drug products. FDA is extending the period for states to decide whether to sign the final MOU, (“Memorandum of Understanding Addressing […]
Outsourcing facilities are compounders registered with the FDA under Section 503B of the Federal Food Drug and Cosmetic Act. They undergo FDA inspections and must follow cGMPs as they relate to compounded prescription drug products that they are authorized to compound. Good news for the 503B facilities – their fees have not gone up much […]
The FDA reviewed five (5) bulk drug substances for inclusion in the bulk APIs that can be used by outsourcing facilities in the compounding of drug products. The five (5) nominated for consideration were: quinacrine HCl, bromfenac sodium, mitomycin–C, nepafenac, and hydroxychloroquine sulfate. Only quinacrine HCL for compounding for oral products for the treatment of […]
How long has it taken for a Final Standard Memorandum of Understanding (MOU) for States regarding Compounding Pharmacies to be issued? Are States or appropriate agencies (referred to as States below) ready to sign, acquire infrastructure, hire the necessary human resources, develop the enabling documentation, execute the requirements of the provisions, create the necessary records, […]
As part of the Agency’s ongoing efforts to ensure patient’s access to drugs, FDA is continuing to develop and evaluate a list of bulk drug substances that 503B Outsourcing Facilities can use in compounding, when it has been determined that there is a clinical/medical need that can’t be met by an available FDA-approved drug. On […]
Outsourcing facilities are compounding facilities defined under section 503B of the Federal Food Drug and Cosmetic Act (FD&C Act). There are yearly fees associated with establishment and re-inspection fees related to entities that compound human drugs and elect to register as outsourcing facilities under the FD&C Act. The FDA has Just published the fees for […]
In late 2018, FDA entered a contract with the National Academies of Sciences, Engineering, and Medicine (the National Academies) to examine the clinical utility (effectiveness), safety and uses of compounded bioidentical hormone therapy (cBHT). A high-level committee was formed and examined in detail the clinical utility of cBHT drug preparations, especially those containing estradiol, estrone, […]
The FDA continues to make drug compounding a high priority and will enforce the requirements of the DQSA. The FDA was very busy last week and, on May 13, 2020, Janet Woodcock, MD, Director, Center for Drug Evaluation and Research, issued two letters, one responding to a citizen’s petition (here) and one announcing the availability […]
Early on Monday morning April 20, 2020, the FDA announced a relaxed policy for pharmacy compounders, if there is a shortage of certain drug products to treat COVID-19 patients that are not available through the normal supply chain or from a registered outsourcing facility. The guidance, titled Temporary Policy for Compounding of Certain Drugs for […]
FDA has been discussing using temporary enforcement discretion in two April 2020 Guidance for Industry documents for sterile compounding during the Covid-19 crisis: “Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Outsourcing Facilities During the COVID-19 Public Health Emergency (here)” and “Temporary Policy Regarding Non Standard PPE Practices for Sterile Compounding by […]
