Pharm Law lecture 8 Flashcards
Is USP apart of the official compendia? WHat did it combine with
yes
COmbined with NF
What are special about drug monographs within the USP
They have the force of law. Not following that information leaves a drug adulterated or misbranded
Does the USP publishing information on the appropriate means for drug preparation and drug storage have a force of law federally.
No, they do not have force of law federally, however, many states have adopted aspects of these chapters into their own law.
Even in states where these do not have the force of law, theya re utilized as standards for competent practice.
What is USP 795 used for? What does it focus on? What are its requirements
non sterile compounding (anything not done in a hood) (tabs, capsules, suspensions)
Focuses on ensuring the quality and safety of nonsterile compounding
Requires beyond use dates (BUDs) to be assigned to nonsterile products
What does USP 797 focus on?
sterile compounding (IV, infusions)
Covers numerous sterile compounding requirements, including personnel, training, facilities, environmental monitoring and storage and testing of finished products
WHat does USP 800 focus on?
Hazardous substances
Discusses 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 mimicing existing hazardous drugs
When do manufacturers have to include an expiration date to their products? Whar is an expiration date?
All manufacturers must assign an expiration date to their products except for supplements and OTC products
The expiration date is the last date the product will meet the requirements of the USP monograph for strength or stability
What are the two ways expiration dates come in
Exact dating
(MMDDYY)
Or
Month and year (when dates as month and year, assume the product is good through the last day of the month noted)
WHat would happen if we had a drug without expiration date
MIsbranded
Define BUD (Beyond use dates)
A BUD is a date after which a product should not be used. It cannot be later than an expiration date and is often sooner
What are BUDs based on?
BUDs are based on many factors, including when a product is opened, storage, reconstitution and stability data
What are the guidelines USP provides for compounded product for BUDs
BUD shall not be later than expiration date on manufacturers container, or
1 year from the date the drug is dispensed, whichever is earlier
What is repackaging
Repackaging occurs when you take a drug from a stock bottle and puts it into a new package without doing other things
Give examples of repackaging
- Moving tablets from a large container into a unit dose packaging
- Taking creams from large containers into smaller containers
- Transferring contents of bulk containers into a machine for future dispensng
repackaging products must meet what
Must meet all provisions of the FDCA
What does NOT meet the criteria for repacking
Importantly, taking a drug out of stock bottle and placing into a prescription bottle for dispensing does NOT meet the citeria for repacking
Does the FDA know that many companies engage in repackaging and may not meet all of the requirements of the FDCA? WHat does it think about it?
Yes, the FDA knows this and has provided guidance where the FDA does not intend to take action against companies for violating the FDCA
What are exemptions the FDA provided to FDCA repackaging violators
- 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 dewcribed in the repacking guidance
What is the guidance in determining BUDs for FDA approved product with specific in use time
BUD established with in use time or the expiration date on the product repackaged, whichever is sooner.
How do you determine BUDs of FDA approved product without an in use time or unapproved product
Non aqueous formulation- No more that 6 months or exp date (whichever is sooner)
Water containing oral formulations- No more than 14 days or the exp dat (whichever is sooner)
Water containing topical, mucosal and semisolid formulations- no more than 30 days or the product expiration date, whichever is sooner
Repackaging guidances on FDA approved sterile products with specified in use time? Without specified in use time or unapproved product?
In use time- BUD established with in use time or the expiration date on the product repackaged, whichever is sooner.
Without specified in use time- BUD established by USP 797 or exp date of the product repackaged
How do inspection occur
A routine inspection
An inspection triggered by knowledge, suspicion, or a formal complaint of wrongdoing that may be a danger to public safety
explain the relationship between pharmacies and FDA inspections
Pharmacies are exempt from FDA insoection per the FDCA, unless the pharmacy manufactures, prepares or compounds drugs or devices
Despite this, the FDA may inspect a pharmacy to determine if they manufacture drugs and to verify compounding is done appropriately
FDA inspectors may request entry to a pharmacy by showing a notice of inspection and their credentials
FDA inspections in pharmacies are rare, but FDA focuses on outsourcing facilities and pharmaceutical industry
