Lecture 8 - USP, Inspections and Generic Equivalency Flashcards
What happens to a drug if it does not follow USP drug monographs?
They have the force of law and not following that information leaves the drug adulterated or misbranded
Do the USP chapters on drug preparation and drug storage have the force of law?
Not federally, but some states have adopted them into their law
What does USP 795 do?
-Focuses on ensuring the quality and safety of nonsterile compounding
-Requires beyond-use dates to be assigned to nonsterile products
What does USP 797 do?
Covers numerous sterile compounding requirements, including personnel, training, facilities, environmental monitoring, and storage and testing of finished products
What does USP 800 do?
Discusses the handling of hazardous drugs in healthcare settings
What does hazardous mean?
-Carcinogenic
-Teratogenic or developmental toxicity
-Reproductive toxicity
-Organ toxicity at low doses
-Genotoxicity
-New drugs that mimic existing hazardous drugs
What is the expiration date of a drug?
The last date the product will meet the requirements of the USP monograph for strength and stability
What are the two ways expiration dates can be written
-Exact dating (January 21st, 2029)
-Month and year (January 2029)
What is a BUD?
-A date after which a product should not be used. It can not be later than the expiration date and is often sooner
-BUDs are based on many different factors, including when a product is opened, storage, reconstitution, and stability and sterility data
USP general guidelines for BUDs for all products
-A BUD shall not be later than the expiration date on the manufacturers container or
-1 year from the date the drug is dispensed, whichever is earlier
What is repackaging?
-When a location takes a drug from a manufacturers bottle and puts it into a new package without doing other things
-Repackaged products must meet provisions of the FDCA
What are the exemptions where the FDA will not take actions against companies violating the FDCA?
-A prescription drug product on the drug shortage list
-A drug product repackaged under direct supervision of a licensed pharmacist
-If repackaged by a pharmacy, only distributed upon receipt of a valid prescription for an individual patient
-Repackaged product is assigned a BUD as described in the repackaging guidance
BUD of a product with an in-use time
The in-use time or the expiration date on the product being repackaged, whichever is sooner
BUD of non-aqueous formulations
No more than six months or the expiration date, whichever is sooner
BUD of water-containing oral formulations
No more than 14 days or the expiration date, whichever is sooner
BUD of water containing topical, mucosal, and semisolid formulations
No more than 30 days or the expiration date, whichever is sooner
BUD of sterile product with specific in-use time
The in-use time or the expiration date, whichever is sooner
BUD of sterile product
Established by USP 797 or the expiration date, whichever is sooner
Two ways an inspection can occur
-A routine inspection
-An inspection is triggered by knowledge, suspicion, or a formal complaint of wrongdoing that may be a danger to public safety
When can the FDA inspect a pharmacy
-To determine if they manufacture drugs and to verify compounding is done appropriately
-Inspectors may request entry to a pharmacy by showing a notice of inspection and their credentials
What does the DEA do in an inspection?
They may examine records and reports related to controlled substances, inspect the premises, and inventory controlled substances without a warrant
What must the DEA do when requesting inspection?
-State the purpose of their inspection
-Show their credentials
-Provide written notice of inspection to the pharmacy owner or pharmacist in charge
Can someone refuse a DEA inspection?
Yes but they will come back with a warrant that can not be refused
What rights are listed out in the DEA notice of inspection?
-You have the right to require the DEA to get an administrative inspection warrant (AIW)
-You have the right to refuse an inspection (at which point they will get an AIW)
-Anything incriminating found can be seized and used against you in prosecution
-You will get a copy of the NOI
-You may withdrawal your consent to inspection at any time
