PA specific compounding rules

Question 1

____ pharmacies are exempt from registering with the FDA and meeting cGMPs

Answer 1

503a

Question 2

what can 503a pharmacies compound

Answer 2

patient-specific prescriptions

Question 3

can 503a pharmacies compound “for office use”

Answer 3

no

Question 4

503a pharmacies are only permitted to use ____ bulk substances

Answer 4

FDA-approved

Question 5

503a compounding restrictions

Answer 5

cannot compound regularly or inordinate amounts of products that are essentially copies of commercially available products or drugs that have been removed from the market after being determined unsafe or ineffective

can participate in anticipatory compounding of limited quantities based on history of past orders