The 5% Rule and Inspections

The 5% Rule and Inspections

The Act returns the state of the law to 2002 by imposing the limitations for "inordinate amounts" and "5%" under 353a(b)(3)(B)(i-ii). Under 353a(b)(1)(D) "a drug product may be compounded" if the pharmacist (or physician) "does not compound regularly or in inordinate amounts...any drug products that are essentially copies of commercially available drug products." The phrase "inordinate amounts" is to be defined by the FDA. The 5% limitation provides that a pharmacy may not compound a product unless:

1. The state where the drug is compounded has a memorandum of understanding (MOU) with the FDA for state investigations of complaints relating to "compounded drug products" distributed out of state; or
2. The total compounded products distributed out of state do not exceed 5% of the total prescription orders.

FDA states that it "does not intend to enforce the 5% limitation until 90 days after FDA has finalized an MOU and made it available to the State... ."

 

quoted from here