Drug shortages have become a persistent threat to patient care, impacting everything from cancer drugs to weight loss medications like semaglutide and tirzepatide, and children’s antibiotics to IV solutions used in hospitals. When FDA-approved drugs are unavailable, compounding pharmacies help bridge the gap by preparing individualized medications based on a valid prescription. These custom medications are compounded under strict quality standards and can mean the difference between a treatment delay and timely care.

Compounding is not a loophole; it is mandated in federal law to assure continuation of patient drug therapies, even when the supply chain breaks down. A great example of this in practice happened early in the COVID pandemic of 2020. To help mitigate certain COVID drug shortages, in April 2020, the FDA issued a temporary guideline allowing pharmacies to prepare COVID-related drugs without a specific prescription for use in hospitals at a time when FDA-approved versions of those drugs were unavailable. FDA says it did not receive a single report of an adverse event – proof that compounding pharmacies can provide safe drugs in urgent shortage settings.

Now, FDA should extend that guidance to allow shortage drug compounding of any shortage drug when a hospital or clinic cannot source it from the manufacturer or an outsourcing facility. 

Is the medicine you normally take unavailable?

• Ask your provider about compounded options when a medication is in shortage.
  
  
• Verify that the pharmacy you use is licensed and experienced in compounding.
  
  

APC is working with Congress, the FDA, and state boards of pharmacy to protect patients’ access to compounded medications during shortages. We support legislative efforts to finalize rules around shortage drug compounding, and we’ve called on regulators to clarify and streamline how pharmacies can compound for patients when FDA-approved options are unavailable. Outsourcing facilities are compounders that are poised to help with widespread shortages – but they need the incentive to do so. We're advocating for policies allowing outsourcing facilities to continue to compound medications for 180-days after shortages are resolved – providing a stronger economic model for those facilities to prepare shortage drugs.