FDA updates hospital pharmacy compounding rules to address potential shortages

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

All of the updates relate to Section 503A of the Act, which outlines the conditions under which drugs may be exempt from certain rules.

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

The four updates:

  1. The FDA said its guidelines on the “1 mile radius” disposal are still in draft form. He did not say when the revision would be released. The one-mile radius provision allows hospital pharmacies to dispense compounded pharmaceuticals to healthcare facilities as long as they are owned and controlled by the same entity as the pharmacy and located within a one-mile radius. mile from pharmacy. The FDA said the draft guidelines have been released for public comment and have not been implemented.
  2. The FDA does not plan to immediately enforce the “5% limit.” The 5% limit prevents hospital pharmacies from dispensing compounded drugs outside of the state in which they were compounded in quantities exceeding 5% of the total prescriptions dispensed by the pharmacy. The rule was put in place because if a large portion of a hospital pharmacy‘s drugs are dispensed across state lines, regulating those products can be logistically and financially difficult. Once the agency has finalized a memorandum of understanding and given states the opportunity to sign it, execution can proceed.
  3. The FDA has clarified which drugs are excluded from the “substantially a copy” provision. Drugs on its shortage list or drugs that are no longer commercially available are not included in the provision. Compound drugs that are considered “essentially a copy” of existing drugs that are already on the market are generally not FDA approved.
  4. The FDA has clarified its position on outsourcing facilities under 503A. He said he does not consider a compound drug produced by a contract facility to be “substantially a copycat” if it is identical or nearly identical to an existing FDA-approved drug that is on the shortage list. The agency clarified this because Section 503A generally only applies to hospital pharmacies and not contract facilities.

Clarifications released by the FDA suggest that hospital pharmacies should be able to compound many of the drugs that are in short supply due to the COVID-19 pandemic, according to the American Hospital Association.

Read the full FDA press release here.

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