Pharmacy groups ask FDA to anticipate shortages,
allow enforcement discretion
On March 27, the American Pharmacists Association, the National Community Pharmacists Association, and the National Alliance of State Pharmacy Associations joined APC in submitting a letter to FDA requesting enforcement discretion to allow compounders to prepare over-the-counter and prescription meds that may go into shortage in the #COVID19 crisis.
"As this health crisis continues, pharmacies, wholesalers and manufacturers are experiencing or are likely to experience shortages of critical OTC and prescription drug products that are needed for patient care. Compounders stand ready to provide needed medications for COVID-19 treatment and drugs in shortage in the U.S. as a result of this global crisis. We seek specific FDA enforcement discretion to compound these products and provide health care professionals and patients safely compounded versions of the medications they need. We ask FDA to engage with the pharmacy compounding community now in identifying drugs in shortage or anticipated to be in shortage and work with us to ensure that timely FDA guidance is clear and thorough regarding scope of authority, formulas, information, and ingredients."
The letter concludes:
"We stand ready to work with the FDA at this critical time - to be a resource on how compounding pharmacies can safely provide critical OTC and prescription drug products in shortage. Our clinical and practical expertise and marketplace knowledge can be a helpful and potent resource to FDA and can improve the effectiveness and clarity of FDA guidance on matters related to compounding during this public health emergency."