Reading 6

Question 1

What was the Prescription Drug Marketing Act (PDMA)?

Answer 1

enacted to fight drug diversion from normal distribution channels and protect public health

Question 2

What are the 6 parts of the PDMA?

Answer 2

1. reimportation
2. preferential pricing
3. samples and coupons
4. wholesale distributors
5. recordkeeping requirements
6. whistleblower awards

Question 3

Although the PDMA normally prohibits reimportation of drugs, what are the two exceptions?

Answer 3

• when done by the manufacturer and no real profit is to be gained (also held to a strict standard when selling drugs in the US)
• when used for emergency use after FDA review

Question 4

If reimported, drugs are considered __________.

Answer 4

adulterated

Question 5

What does the preferential pricing section of the PDMA state?

Answer 5

you cannot sell, purchase, or trade (or offer to) drugs purchased at a reduced price by a hospital/healthcare facility or donated to charity

IF IT WAS PREFERENTIALLY PRICED, IT CANNOT BE SOLD TO AN ORGANIZATION WHO WOULD NOT NORMALLY GET THAT PRICE!

Question 6

True or false: according to the PDMA, drug samples cannot be sold or purchased, but they can be traded.

Answer 6

false

Question 7

True or false: retail pharmacies cannot have prescription samples on the premises.

Answer 7

true

Question 8

What are the PDMA recordkeeping requirements?

Answer 8

must keep records relating to PDMA for 3 years (can be electronic if easily retrievable and resistant to changes)

Question 9

What was the Federal Anti-Tampering Act?

Answer 9

enacted after Chicago Tylenol poisonings, and created 5 new crimes: tampering, tainting, communicating false information, threatening to tamper, and conspiring to tamper

Question 10

When is tamper-evident packaging required?

Answer 10

for all products available directly to a patient on a retail shelf (OTC and other consumer products)

Question 11

What three things are required of tamper-evident packaging?

Answer 11

1. 1+ indicators or barriers of entry
2. distinctive packaging or difficult to reproduce
3. ability to remain intact during handling

Question 12

What type of labeling is also required of tamper-evident packages?

Answer 12

prominently-placed statement of all tamper-evident features

Question 13

What was the Dietary Supplement Health and Education Act (DSHEA)?

Answer 13

established the dietary supplement category, which allowed manufacturers to make certain claims about their product without being reviewed by the FDA prior to marketing

Question 14

Dietary supplement manufacturers must notify the FDA within _________ after marketing their product.

Answer 14

30 days

Question 15

True or false: supplements must show evidence of GRAS/GRAE

Answer 15

false