FDA updates hospital pharmacy compounding rules to address potential shortages

The FDA released four updates on the rules hospital pharmacies must follow under the federal Food, Drug and Cosmetic Act when it comes to compounding drugs to address problems that may arise during the COVID-19 pandemic. 

All of the updates relate to section 503A of the act, which outlines conditions under which drugs can be exempt from certain rules. 

The FDA said it is issuing the updates to provide clarification and guidance to compounding pharmacies on issues associated with compounding drugs during the COVID-19 pandemic and to protect patients from unsafe, ineffective or poor-quality compounded drugs. 

The four updates: 

  1. The FDA said its guidance on the "1 mile radius" provision is still in draft. It didn't say when the revision would be released. The 1 mile radius provision allows hospital pharmacies to distribute compounded drug products to healthcare facilities as long as they are owned and controlled by the same entity as the pharmacy and are located within a 1 mile radius of the pharmacy. The FDA said the draft guidance has been issued for public comment and hasn't been implemented.

  2. The FDA doesn't plan to enforce the "5 percent limit" right away. The 5 percent limit blocks hospital pharmacies from distributing compounded drug products outside of the state in which they were compounded in quantities that exceed 5 percent of the total prescription orders dispensed by the pharmacy. The rule was put in place because if a large portion of a hospital pharmacy's drugs are distributed outside a state's borders, regulating those products can be difficult logistically and financially. After the agency finalizes a memorandum of understanding and gives states a chance to sign it, enforcement can proceed.

  3. The FDA clarified drugs excluded from the "essentially a copy" provision. Drugs on its shortage list or drugs that are no longer commercially available aren't included in the provision. Compounded drugs that are considered to be "essentially a copy" of existing drugs that are already on the market are typically not approved by the FDA.

  4. The FDA clarified its stance on outsourcing facilities under 503A. It said it doesn't consider a compounded drug produced by an outsourcing facility as "essentially a copy" if it is identical or nearly identical to an existing FDA-approved drug that is on the shortage list. The agency clarified this, as section 503A typically only applies to hospital pharmacies and not outsourcing facilities. 

The clarifications issued by the FDA suggest that hospital pharmacies should be able to compound many of the drugs that are in short supply because of the COVID-19 pandemic, according to the American Hospital Association

Read the FDA's full news release here.


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