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 Hospitalized Patients by Pharmacy Compounders Not Registered as Outsourcing Facilities During the COVID-19 Public Health Emergency (here), provides an exception for a pharmacy not registered as an outsourcing facility to compound certain drug products on the list provided in the guidance that are exact copies of approved drug products.

As you are aware, 503A pharmacy compounders are not permitted to make exact duplicates of an approved drugs product and, for those products they do compound, they must have a valid prescription (for the most part) for a specific patient prior to compounding a special product that meets an individual patient’s need.  The criteria listed to permit FDA enforcement discretion to allow for this temporary exception to permit pharmacies to compound exact duplicates of an FDA approved drug product on the list to hospitals treating COVID-19 patients and to waive the requirements that they be accompanied by an individual patient prescription are narrow, and include the following (among other things):

  • The product must be on the list of products on Appendix A of the guidance
  • The product’s beyond use date (BUD) is short and in compliance with the BUDs outlined in Appendix B of the guidance and, in most cases, is shorter that the listed BUD date.
  • It must be for a hospital that is treating COVID-19 patients that has made a good faith attempt to source the products from the normal supply chain or registered outsourcing facility.
  • The pharmacy has given notice to the state authority that regulates compounding practices in the state to determine that the practice is acceptable to the state authority.
  • This guidance regarding enforcement discretion and flexibility will expire once the national health emergency is over and will be rescinded at that time.

There are 13 critical care drugs on the list for which enforcement discretion will be exercised.  These products also appear on the FDA drug shortage list but are the only ones for which the provisions of this guidance apply.