Federal Pharmacy Law and Regulation: Reading 5

Question 1

The ______________ Act of 1987 was passed due to some individuals diverting prescription drugs and drug samples from the normal distribution channels

Answer 1

The Prescription Drug Marketing Act of 1987 (PDMA)

Question 2

What was the purpose of the Prescription Drug Marketing Act of 1987? (And subsequent Prescription Drug Amendments of 1992)

Answer 2

to protect public health, and to protect the public against drug diversion by establishing procedures, requirements, and minimum standards for the distribution of prescription drugs and prescription drug samples.

Question 3

Prescription Drug Marketing Act of 1987 prohibits the reimportation of a prescription drug into the US UNLESS…. (2)

Answer 3

unless reimported by the manufacturer of the drug (avoid adulteration) OR for emergency use after review by the FDA

Question 4

T or F?

Prescription Drug Marketing Act of 1987 bans the actual or offer to sell, purchase, or trade a prescription drug that was purchased by a hospital or other healthcare facility, as well as donated or supplied to a charity at a reduced price.

Answer 4

True

Question 5

T or F?

Prescription Drug Marketing Act of 1987 prohibits the actual or offer to sell, purchase, or trade a drug sample and prohibits the sale, purchase, trade, and counterfeiting of drug coupons.

Answer 5

True

Question 6

Which Act requires practitioners to ask for drug samples in writing, prohibits retail pharmacies from having any drug samples at any time, and establishes record keeping, storage, and handling requirements for drug samples?

Answer 6

Prescription Drug Marketing Act of 1987

Question 7

Scenario:

Retail pharmacy carries drug samples on their premises - which Act does this violate and why?

Answer 7

Prescription Drug Marketing Act of 1987

It’s considered drug diversion. Manufacturers can only give to practitioners/clinics with a written request.

Question 8

Which Act has detail requirements for wholesale distributors, how records should be kept and how to respond to record requests, as well as how to apply for a “whistleblower” award for turning in someone who is violating said Act?

Answer 8

Prescription Drug Marketing Act of 1987

Question 9

In regards to Prescription Drug Marketing Act of 1987, how are records kept in regards to recordkeeping? How long should these records be maintained for?

Answer 9

Electronic format as long as they are easily retrievable and resistant to tampering, modification, or unauthorized use and should be maintined for THREE years

Question 10

If you provide information on someone violating the PDMA and that information leads to a convinction, you are…

Answer 10

“entitled to one-half of the criminal fine imposed and collected for such violation, but not more than $125,000

Question 11

Regarding wholesale distributors -

Who must license wholesalers?

Answer 11

States

Wholesalers must keep a record of their purchase of a product and provide a statement of origin if they are not an authorized distributor, and manufacturers must maintain a list of authorized distributors in their corporate office.

Question 12

The event that led to 7 people dying due to cyanide poisoning from tampered Tylenol bottles, let to the passage of what Act?

Answer 12

Federal Anti-Tampering Act in 1983

*made it a federal offense to tamper with consumer products.

Question 13

What 5 crimes are associated with Federal Anti-Tampering Act in 1983?

Answer 13

Those five crimes are tampering or attempting to tamper with a product’s packaging or labeling, tainting a product, communicating false information that a product has been tainted, threatening to tamper with a product, and conspiring to tamper with a product.

*consumer products, not prescriptions

Question 14

Which Act enforced requiring tamper-evident packaging?

Answer 14

Federal Anti-Tampering Act in 1983

required for OTC drug products that are directly available to patients.

Question 15

Tamper-evident packaging has…

Answer 15

“one or more indicators or barriers to entry which, if breached or missing, can reasonably be expected to provide visible evidence to consumers that tampering has occurred.”

The package must also have one or more indicators or barriers to entry that use an identifying characteristic like a trademark, pattern, phrase, or picture.

Finally, a prominently placed statement on the package identifying all the tamper-evident features must be on the package in a place that cannot be removed

Question 16

T or F?

Manufacturers can apply for an exemption to tamper-evident packaging rules if the requirements are unneccessary or cannot be achieved.

Answer 16

True

Question 17

____________________ Act of 1994 established the category of dietary supplements and “significantly altered the FDA’s authority to regulate dietary supplements.”

Answer 17

The Dietary Supplement Health and Education Act of 1994

Question 18

Based on rules in the DSHEA, the FDA is forced to treat dietary supplements as a spectial type of…

Answer 18

FOOD, instead of as drugs!

Question 19

T or F?

The Dietary Supplement Health and Education Act of 1994 allow manufactureres to make certain statements about dietary supplements relating to a structure of function in the body if the statement includes any of the four following things:

1. “Claims a benefit related to a classical nutrient deficiency disease and discloses the prevalence of such disease in the United States
2. Describes the role of a nutrient or dietary ingredient intended to affect the structure or function in humans
3. Characterizes the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function
4. Describes general well-being from consumption of a nutrient or dietary ingredient.”

Answer 19

True

*the manufacturer of the dietary supplement MUST have evidence that the claim is truthful and not misleading.

Question 20

T or F?

A dietary supplement/product must contain the disclaimer “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”

Answer 20

True

prominently displayed in boldface type.

Question 21

If a manufacturer wants to make one of the allowed statements/claims, it must notify the FDA within ____ days of first marketing the product.

Answer 21

30

Question 22

T or F?

A dietary supplement CAN make claims about a disease, which is defined as “damage to an organ, part, structure, or system of the body such that it does not function properly (e.g., cardiovascular disease), or a state of health leading to such dysfunctioning (e.g., hypertension).”

Answer 22

FALSE; can NOT

**This definition of disease does not include “diseases resulting from essential nutrient deficiencies (e.g., scurvy, pellagra).”

Those elements are only meant to be used when “the statement implies disease prevention or treatment,” not when claims “refer to the ability of a product to maintain healthy structure or function.”