E1 Lecture 7 Flashcards
Do drug monographs in the USP have the force of law?
Yes, and if they are violated –> adulterated or misbranded
Do means for drug preparation and drug storage in the USP have the force of law?
No, they do not have the force of law federally; however, many states have adopted aspects into their own law
USP 795
focuses on ensuring the quality and safety of nonsterile compounding
- requires BUD
USP 797
focuses on ensuring the quality of sterile compounding
- personnel
- training
- facilities
- monitoring of the environment
- storage/testing of products
USP 800
focuses on the handling of hazardous drugs in healthcare settings
Hazardous
- carcinogenic
- teratogenic
- reproductive toxicity
- organ toxicity @ low doses
- genotoxicity
- new drugs mimicking existing hazardous drugs
Expiration Date
last date the product meets requirements for USP monograph for strength or stability
Beyond Use Date
date after which a product should not be used –> cannot be later than an expiration date
Factors affecting BUD
- opened
- storage
- reconstitution
- stability/sterility
USP Guidance on BUD for ALL products
no later than expiration date on manufacturer container
or
1 year from date of dispensed
Repackaging
when a location takes a drug from a manufacturer’s bottle and puts it into a new package without doing other things
MUST MEET PROVISIONS OF FDCA
Is taking a drug out of a stock bottle and placing into a prescription bottle for dispensing repackaging?
No
Exemptions of FDA for not following FDCA
- prescription drug product on the drug shortage list
- drug product repackaged under the direct supervision of a licensed pharmacist
- if repackaged by a pharmacy, only distributed upon receipt of a valid prescription for individual patient
- repackaged product is assigned a BUD as described by guidance
FDA-approved product with specific in-use time
BUD established with in-use time
or
expiration date on product repackaged
FDA-approved product without in-use time/unapproved product –> non aqueous
no more than 6 months
or
expiration date
FDA-approved product without in-use time/unapproved product –> water containing ORAL formulation
no more than 14 days
or
expiration date
FDA-approved product without in-use time/unapproved product –> water containing topical, mucosal, semisolid formulation
no more than 30 days
or
expiration date
FDA-approved STERILE product with specific in-use time
BUD established with in-use time
or
expiration date on product repackaged
FDA-approved STERILE product without specific in-use time
BUD established by USP 797
or
expiration date on product repackaged
Types of Inspections
- route inspection (random)
- inspection triggered by knowledge, suspicion, or formal complaint
FDA Inspection
pharmacies are exempt from FDA inspections per FDCA unless the pharmacy manufactures, prepares, or compounds
- may inspect to determine if they manufacture or verify compounding quality
- request entry by showing NOI (FDA Form 482) & credentials
DEA Inspections
may inspect any place where controlled substances are kept
- examine records related to controlled substances
- inspect premises
- inventory controlled substances WITHOUT a warrant
Request entry:
- state purpose of inspection
- show credentials
- provide written NOI to pharmacy owner or pharmacist in charge
Can a pharmacist refuse inspection by DEA?
Yes, at any time but they will return with warrant
DEA Notice of Inspection Rights
- right to require DEA to get an administrative inspection warrant
- right to refuse an inspection
- anything incriminating found can be seized and used against you in prosecution
- receive copy of NOI
- may withdrawal your consent of inspection at ANY time
