APhA coronavirus watch: FDA clarifies compounding rules for drugs in shortage during pandemic

Hospital and community compounding pharmacists will have more flexibility thanks to FDA guidances aimed at easing drug shortages during the COVID-19 pandemic. The agency will use discretion in enforcing certain standards around 503A and 503B compounding.

FDA representatives on an APhA webinar said that the agency will look to 503B compounders to grapple with drug shortages and turn to 503A compounders to fill the gaps.

Among the most notable of FDA’s clarifications is that medications on the agency’s drug shortage list are effectively considered to be “not commercially available,” freeing 503A and 503B compounding facilities from limits on compounding drugs that are “essentially a copy” of a product already available on the market. That means a compounding pharmacist could copy an otherwise commercially available drug, as long as it is for a specific patient and meets other conditions.

FDA also announced it does not intend to take action if a 503A facility fills orders for a compounded drug that is essentially a copy of an approved drug that has been discontinued and is no longer marketed.

Additional temporary guidance granted flexibility for pharmacists to compound certain necessary medications under 503A for nonspecific patients hospitalized due to COVID-19.

Temporary FDA guidance granted enforcement flexibility for 503B outsourcing compounding facilities for drugs in shortage for patients hospitalized during the COVID-19 public health emergency.

Compounders must meet certain conditions to benefit from the enforcement discretion in these guidances.

Drugs in shortage vary widely across states and regions, as many drugs are diverted to areas that are harder hit by COVID-19. Intravenous drugs to maintain patients on ventilators, like midazolam and propofol, are particularly affected by supply chain disruptions related to the COVID-19 pandemic. View FDA’s list of drugs in shortage.

Pharmacists who qualify as 503A compounders under the Federal Food, Drug, and Cosmetic (FD&C) Act are state-licensed pharmacists, licensed physicians, or federal facilities that compound drugs that do not require new drug applications and are exempt from current good manufacturing processes (CGMP). These facilities are limited to dispensing compounded products for home use and are not allowed to compound large batches. Compounding facilities that fall under the 503B section of the FD&C Act manufacture larger batches of compounding products with or without prescriptions to be sold to health care facilities for office use. Those that provide patient-specific medications are held to higher regulatory standards. These facilities are required to maintain full compliance with CGMP.

In March 2020, APhA and other pharmacy groups signed onto a joint letter advocating for relaxation of enforcement for “essentially a copy” of FDA-approved drugs so 503A compounding pharmacies could help meet urgent needs during the pandemic response. On April 10, APhA organized a virtual listening session with the FDA Center for Drug Evaluation and Research (CDER) and national pharmacy organizations to share information about how drug shortages affect pharmacy practice and patient care during the COVID-19 pandemic—particularly drugs at risk of being in short supply in the near future or currently in short supply in the community and hospital settings.

Pharmacists and others affected by shortages can report them to FDA at drugshortages@fda.hhs.gov.