Prohibited Acts, Penalties, and Enforcement

Question 1

What are the two major prohibitions?

Answer 1

Adulteration and misbranding

Question 2

(T/F) You are liable for adulteration and misbranding regardless of intention or knowledge

Answer 2

True

Question 3

(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)

Answer 3

False

Question 4

(T/F) For pharmacists who repackage or relabel drugs, either prescription or OTC, the new label must confirm to FDA specifications, or constitutes misbranding

Answer 4

True

Question 5

How does the FDA enforce the FDCA?

Answer 5

1. Injunction: cause a violator to stop its illegal activity
2. Criminal proceedings: jail time/or fines
3. Seize adulterated or misbranded food, drugs, cosmetics
4. Send warning letters
5. Corporate officer liability - officers can be convicted when their employees violate FDCA
6. Product Recalls: FDA has authority or manufacturer can voluntarily recall; manufacturer responsible for contacting consumers. Pharmacists should know which drug products have been recalled

Question 6

Type of recall where reasonable probability that the product will cause serious adverse health consequences or death

Answer 6

Class I recall

Question 7

Type of recall where product may cause temporary or medically reversible adverse health consequences, but the probability of serious adverse consequences is remote

Answer 7

Class II recall

Question 8

Type of recall where products are not likely to cause adverse health consequences

Answer 8

Class III recall

Question 9

Who does adulteration mostly apply to?

Answer 9

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)

Question 10

When is a drug deemed adulterated?

Answer 10

1. Prepared, packed, or held in conditions where it may have been contaminated
2. Exposed to a container that may have contaminated it
3. Manufactured under conditions that do not conform to current good manufacturing practices (GMP)
4. Strength, quality, or purity differs from those on the label or from compendia standards if it’s subject to compendia

Question 11

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?

Answer 11

Good Manufacturing Practices (GMP)

Question 12

Who does the GMP apply to?

Answer 12

Manufacturers (not pharmacies unless they engage in activities where they could be deemed manufacturers)

Question 13

Who do manufacturers need to register with for GMP?

Answer 13

FDA

Question 14

How often are manufacturers inspected for GMP?

Answer 14

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

Question 15

How are drugs subject to GMP selected?

Answer 15

Based on

• medical importance
• market share
• number of similar products in the marketplace
• previous compliance record of manufacturer

Question 16

What was passed to make it a federal offense to tamper with consumed products?

Answer 16

Federal Anti-Tampering Act of 1982

Question 17

Improper interference with the product for the purpose of making objectionable or unauthorized changes

Answer 17

Tampering

Question 18

Representations made by the manufacturer’s label or labeling

Answer 18

Misbranding

Question 19

Who needs to approve, as part of pre-market approval, the exact wording of a drug’s label and labeling?

Answer 19

FDA

Question 20

What is considered misbranding?

Answer 20

• 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