Compounding

Question 1

Registration requirements for sterile-compounding

Answer 1

Must register as an outsourcing facility

Question 2

Licensing requirements for non-sterile compounding

Answer 2

Nothing specific

Question 3

Can outsourcing facilities dispense meds to a person pursuant to a Rx?

Answer 3

No

Unless…. it is also registered as a pharmacy

Question 4

Are outsourcing facilities considered pharmacies?

Answer 4

Not all, only those that are also registered as pharmacies

Question 5

Outsourcing facility record keeping requirements

Answer 5

Must send a report to the executive secretary of the state board every 6 months with all drugs compounded in that time:
- API
- Source
- NDC
- Strength of API
- package description
- number of units produced

Question 6

Restrictions on compounding without a prescription

Answer 6

Must be pursuant to a patient specific order

Exception: may compound limited quantities in advance of a valid Rx for an individual patient who has a steady history of receiving the med at the pharmacy

Question 7

Can you compound a copy of an FDA approved drug?

Answer 7

OH NO, THEIR INTELLECTUAL PROPERTY!

sooooooo no

Question 8

can outsourcing facilities dispense without Rx?

Answer 8

Nah bro