On April 3, 2025, the Massachusetts Board of Registration in Pharmacy issued a memorandum that directly affects 503A retail pharmacies that purchase compounded preparations from 503B outsourcing facilities with the intent to sell those compounded preparations to patients. It’s crucial to understand how these regulations impact your business’s ability to receive and use compounded medications.
Key Takeaways from the Memorandum:
- Prohibition on Redispensing Compounds from 503B Outsourcing Facilities
Under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act), outsourcing facilities are prohibited from wholesaling compounded preparations with the intent to have them resold or transferred by another entity.
Massachusetts law currently prohibits 503A retail pharmacies from accepting and re-dispensing compounded drugs received from 503B outsourcing facilities. As a business that works with these pharmacies, this means that you cannot legally acquire compounded preparations from them, as they are not allowed to be transferred or redispensed for resale by another entity. - FDA’s Draft Guidance on Compounds from 503B Outsourcing Facilities
The FDA has issued draft guidance that suggests it may eventually allow retail pharmacies to dispense compounded medications sourced from 503B outsourcing facilities. However, it’s important to note that this guidance is still in draft form and is labeled “Not for Implementation.” Until this guidance is finalized, Massachusetts state law prohibits the practice because this activity would be considered a violation of 247 CMR 9.01(5), which states that, “[u]nless otherwise permitted by law, regulation, or Board policy, a licensee may not re-dispense any medication that has been previously dispensed.”
This means that even though the FDA’s proposal could eventually allow for this type of distribution, Massachusetts regulations will prohibit this type of distribution unless the FDA’s draft proposal is finalized, and businesses cannot rely on the possibility of this future change for current purchasing decisions.
What This Means for Your Business:
- Do Not Acquire Compounds from 503B Facilities via 503A Pharmacies: Businesses must refrain from sourcing compounded medications from 503A retail pharmacies that have obtained their supplies from 503B outsourcing facilities. Such compounds are not authorized for resale under Massachusetts law, and accepting these compounds for business purposes would be a violation of state regulations.
- Regulations Could Change in the Future: While the current regulations prevent businesses from acquiring compounded drugs through this route, the FDA’s draft guidance suggests a potential future shift. However, until that guidance is finalized, businesses must comply with the current legal framework.
What Should Businesses Do Now?
- Review Your Sourcing Practices: If your business relies on purchasing compounded preparations from 503A retail pharmacies, it is essential to review your current purchasing agreements and ensure that you are not violating state regulations by accepting compounds obtained from 503B outsourcing facilities.
- Stay Updated on Regulatory Changes: Given that this is an evolving issue, businesses should monitor both FDA and Massachusetts Board of Registration in Pharmacy updates to ensure compliance with any new regulations or guidance that may impact the legal status of these compounds.
Conclusion:
This recent memorandum serves as a reminder to businesses working with 503B pharmacies about the legal restrictions on acquiring compounded preparations from these facilities. Until the FDA finalizes its draft guidance and Massachusetts updates its regulations, businesses must refrain from accepting compounds obtained from 503B outsourcing facilities via 503A pharmacies.
For any questions or if you need further clarification on how these regulations may impact your business operations, the Lengea team is here to support you.