Upcoming FDA dates

I was trying to figure out what to expect in the next couple months and thought I'd pass along what I found.

To avoid unnecessary disruption to patient treatment, the FDA does not intend to take action against compounders:

  • Until February 18, 2025 for 503A pharmacies.
  • Until March 19, 2025 for 503B outsourcing facilities. 

(https://www.fda.gov/drugs/drug-safety-and-availability/fda-clarifies-policies-compounders-national-glp-1-supply-begins-stabilize)

Lavender Sky Health (LSH) is my telehealth provider. My supplier is a 503B outsourcing facility. LSH's website is pretty clear about which suppliers are 503A pharmacies and which are 503B outsourcing facilities.

503A pharmacies create customized medications based on individual patient prescriptions and are regulated by state boards. 503B outsourcing facilities produce larger batches of compounded drugs and must comply with stricter FDA regulations.

(https://www.fda.gov/drugs/human-drug-compounding/fdc-act-provisions-apply-human-drug-compounding)