The Fluid Regulatory Environment

The current regulatory environment is constantly changing to support patient care, and pharmacists bear the responsibility to ensure that they understand changes to federal as well as state laws, rules, and guidelines.

Examples of recent changes are the FDA Guidance to Outsourcing Facilities on assigning BUDs, and the DEAs policy statement on the temporary waiver of the 5% rule regarding distribution of controlled substances.

FDA Guidance to Outsourcing Facilities on BUD

DEA statement on waiver of 5% transfer rule

Some state Boards of Pharmacy have issued statements on how regulated pharmacies in their state should proceed with the policy statements noted above while others have not. Given how new some of the federal guidelines are and the process to update state board rules, it is critical that pharmacists monitor national pharmacy association websites, state board websites/news releases, state pharmacy association websites, and other content providers.

State Boards of Pharmacy List provided by NABP

We all want to ensure patients are served regardless of setting and protect our businesses from regulatory entanglements. It is crucial that pharmacists are proactive and contact your Board of Pharmacy so that your voice is heard and you can serve your patients fully without fear of repercussion.

Follow federal and state regulations with the Alliance for Pharmacy Compounding

APC is tracking legislation on compounding issues, with weekly updates to their “Compounders Stateside” monitoring and compilations of state adoption of USP and office use guidelines. Become a member of APC for full access.

See how APC is monitoring and advocating at the state level >

Letco is proud to stand with APC.