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
Who can sign an NOI?
owner, operator, or agent in charge
Administrative Inspection Warrant
provided for anything considered a valid public interest –> easy
Search Warrants
provided that an officer can “convince a judge that a reasonable person would believe that a crime has been or will be committed on the premises to be searched” –> hard
At what times can these warrants serve?
AIW: regular business hours
SW: anytime
Board of Pharmacy Inspections
you cannot refuse these routine inspections due to their ability to grant licensure
BOP can inspect WITHOUT a warrant
Approved Drug Products with Therapeutic Equivalence Evaluations
Orange book
provides equivalency ratings for products
Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations
Purple book
provides interchangeable biological product information
Reference Listed Drug (RLD)
original brand name product
Reference Standard
product to which generic has demonstrated equivalency
Therapeutic Equivalence
Pharmaceutical Equivalence
- active ingredient
- dosage form
- strength
- route
- labeling
AND
Bio-Equivalence
- in vivo human results
- in vitro lab results
What does the first letter of therapeutic equivalence code mean?
relevant therapeutic equivalence code –> can you substitute or not
- A = yes
- B = no
What does the second letter of therapeutic equivalence code mean?
dosage form
DRUGS WITH A 3 LETTER CODE ARE CONSIDERED THERAPEUTICALLY EQUIVALENT ONLY TO OTHER DRUGS WITH THE SAME 3 LETTER CODE
DRUGS WITH A 3 LETTER CODE ARE CONSIDERED THERAPEUTICALLY EQUIVALENT ONLY TO OTHER DRUGS WITH THE SAME 3 LETTER CODE
