Prohibited Acts, Penalties, and Enforcement Flashcards
What are the two major prohibitions?
Adulteration and misbranding
(T/F) You are liable for adulteration and misbranding regardless of intention or knowledge
True
(T/F) It is legal for pharmacists to make, dispense, or hold for dispensing a counterfeit drug (includes dispensing a placebo or dispensing a drug labeled as another drug)
False
(T/F) For pharmacists who repackage or relabel drugs, either prescription or OTC, the new label must confirm to FDA specifications, or constitutes misbranding
True
How does the FDA enforce the FDCA?
- Injunction: cause a violator to stop its illegal activity
- Criminal proceedings: jail time/or fines
- Seize adulterated or misbranded food, drugs, cosmetics
- Send warning letters
- Corporate officer liability - officers can be convicted when their employees violate FDCA
- Product Recalls: FDA has authority or manufacturer can voluntarily recall; manufacturer responsible for contacting consumers. Pharmacists should know which drug products have been recalled
Type of recall where reasonable probability that the product will cause serious adverse health consequences or death
Class I recall
Type of recall where product may cause temporary or medically reversible adverse health consequences, but the probability of serious adverse consequences is remote
Class II recall
Type of recall where products are not likely to cause adverse health consequences
Class III recall
Who does adulteration mostly apply to?
Manufacturers (pharmacy may be deemed manufacturer if it repackages or compounds medications for sale but the concern is with the facility and means of production rather than the product itself)
When is a drug deemed adulterated?
- Prepared, packed, or held in conditions where it may have been contaminated
- Exposed to a container that may have contaminated it
- Manufactured under conditions that do not conform to current good manufacturing practices (GMP)
- Strength, quality, or purity differs from those on the label or from compendia standards if it’s subject to compendia
What are the set of regulations that establish minimum requirements for the methods, facilities, or controls used in the manufacture, processing, packaging, or holding of a drug product?
Good Manufacturing Practices (GMP)
Who does the GMP apply to?
Manufacturers (not pharmacies unless they engage in activities where they could be deemed manufacturers)
Who do manufacturers need to register with for GMP?
FDA
How often are manufacturers inspected for GMP?
Every 2 years
- confirm that the production and control procedures result in the proper identity, strength, quality, and purity of the drugs
- identify deficiencies
- ensure correction of deficiencies
How are drugs subject to GMP selected?
Based on
- medical importance
- market share
- number of similar products in the marketplace
- previous compliance record of manufacturer
What was passed to make it a federal offense to tamper with consumed products?
Federal Anti-Tampering Act of 1982
Improper interference with the product for the purpose of making objectionable or unauthorized changes
Tampering
Representations made by the manufacturer’s label or labeling
Misbranding
Who needs to approve, as part of pre-market approval, the exact wording of a drug’s label and labeling?
FDA
What is considered misbranding?
- false or misleading labeling
- no Name and Place of business of the manufacturer, packer, or distributor, and inaccurate statement of the Quantity of the contents in terms of weight, measure, or numerical count
- no name of drug, name and quantity, or if deemed appropriate, the proportion of each active ingredient, and the established name of each inactive ingredient listed in alphabetical order on the outside container of the retail package for OTC
- no adequate directions for use
- no habit forming drug warning
