Florida "Office Use" Compounding?

[josh6718]

---

Members don't see this ad.

Is it legal for a community pharmacy under federal law to compound a prescription for 'office use' without being registered as a manufacturer or outsourcing facility? It was my understanding that the FDA requirements indicated that prescriptions had to be based on individual "patient-specific" relationships and not be distributed to other pharmacies or physician offices?

 

[zelman]

Is it legal for a community pharmacy under federal law to compound a prescription for 'office use' without being registered as a manufacturer or outsourcing facility? It was my understanding that the FDA requirements indicated that prescriptions had to be based on individual "patient-specific" relationships and not be distributed to other pharmacies or physician offices?

I believe you are correct. Compounding is a preparation for a specific patient. High volume compounders like NECC had offices placing orders for "Mickey Mouse" and "Santa Claus" to circumvent this requirement. The regulators auditing them were not happy about it.

 

[Apotheker2015]

Is it legal for a community pharmacy under federal law to compound a prescription for 'office use' without being registered as a manufacturer or outsourcing facility? It was my understanding that the FDA requirements indicated that prescriptions had to be based on individual "patient-specific" relationships and not be distributed to other pharmacies or physician offices?

It's also OK for the pharmacy to compound X cream ahead of time if they know they require Y amount for their own patients and the orders they get from local clinics. That's when you get into the 5% rule, etc. You can take it from here. It's all in your law book.