Product Acquisition & Distribution

Question 1

Acquisition & Distribution of Pharmaceutical Products, including Samples

Food & Drug Act of 1906 regulated cosmetics and medical devices; also, it required manufacturers to list ingredients and directions for use on labels

True or False

Answer 1

• False!
• Did not regulate these & it did not require manufacturers to list ingredients or directions for use on label
• Act prohibited Interstate Commerce of adulterated food, drinks, & drugs

Question 2

Acquisition & Distribution of Pharmaceutical Products, including Samples

Fair Packaging & Labeling Act

Definition

Answer 2

Required consumer products in interstate to be properly labeled (including OTCs)

Question 3

Acquisition & Distribution of Pharmaceutical Products, including Samples

Which act was enacted to correct problems of diversion from normal distribution channels?

Answer 3

Prescription Drug Marketing Act 1987 (Dingle Bill)
* Proper storage/maintenance of distribution records
* Restrict resale of drug products by hospitals (samples)
* Wholesalers must be state licensed
* Companies cannot ship drugs between states without being registered in the destination state

Question 4

Acquisition & Distribution of Pharmaceutical Products, including Samples

Which act restricts sales, purchase, and trade of drug samples?

Answer 4

Prescription Drug Marketing Act 1987 (Dingle Bill)

Question 5

Acquisition & Distribution of Pharmaceutical Products, including Samples

Possession of samples by retail pharmacies is considered drug diversion by the FDA

True or False

Answer 5

True
* only starter packs are allowed - free to pharmacies; intended to initiate therapy; vouchers or coupons
* drug samples obtained by a practitioner can’t even be delivered to a retail pharmacy for the distribution that practitioner’s patients

Question 6

Acquisition & Distribution of Pharmaceutical Products, including Samples

What is required for institutional pharmacies to receive samples?

Answer 6

• Written request by licensed prescriber
• Disposition is precisely recorded
• Store separately from normal drug stock

Question 7

Acquisition & Distribution of Pharmaceutical Products, including Samples

Who keeps the prescriber’s written request for samples and for how long?

Licensed practitioners’ written requests for samples

Answer 7

Drug manufacturers / Distributors keep requests for 3 years

Question 8

Acquisition & Distribution of Pharmaceutical Products, including Samples

Who are responsible for samples’ annual inventory?

Answer 8

Sales Representatives

Question 9

Acquisition & Distribution of Pharmaceutical Products, including Samples

Labeling is required for all samples.

True or False

Answer 9

False
* not required for non-controls that are 120 dosage units, 30 day supplies in solid form, or 8 oz liquid form

Label is required for non-controls that are more than these quantities

Question 10

Acquisition & Distribution of Pharmaceutical Products, including Samples

Should a sample be labeled if it is not in the manufacturer’s original packaging? What if directions for use are not provided by the manufacturer?

Answer 10

Yes - the physician must label it to meet nonsample Rx requirements, and shall give adequate written directions

Question 11

Acquisition & Distribution of Pharmaceutical Products, including Samples

Distribution

Basic Definition

Answer 11

Delivery of a drug or device, other than by ways of administering or dispensing

Question 12

Acquisition & Distribution of Pharmaceutical Products, including Samples

Who is categorized as a “wholesale distributor”?

Answer 12

• Manufacturers
• Repackagers
• own/private-label distributors
• Retail pharmacies that conduct wholesale distribution

Warehouses (manufacturers, distributors, chain drug wholesalers)

Question 13

Acquisition & Distribution of Pharmaceutical Products, including Samples

Wholesale distributors include health care entities that are members of a group-purchasing organization

True or False

Answer 13

False
* Does not include the purchase or acquisition by hospitals or heath care entities that are members of a group-purchasing organizations

Question 14

Acquisition & Distribution of Pharmaceutical Products, including Samples

Wholesale distributors do not include intracompany sales. What is the definition of intracompany sales?

Answer 14

transaction or transfer between a division, subsidiary, parent, or affiliated/related company under the common ownership and control of a corporate entity

Question 15

Acquisition & Distribution of Pharmaceutical Products, including Samples

The sale, purchase, or trade of a drug for emergency medical reasons is not included in wholesale distribution

True or False

Answer 15

True
Transferor or transferee pharmacies’ gross dollar value of transfers may not exceed 5% of total legend drug sales revenue during 12-mo period

legend drug transfer by a pharmacist to another PharmD or practitioner

Question 16

Acquisition & Distribution of Pharmaceutical Products, including Samples

Which of the following is NOT required on the manufacturer’s drug container label for an oral drug product?

1. Manufacturer name
2. Expiration date
3. Drug or Product name
4. Directions for administration
5. Net quantity packaged

Answer 16

Directions for administration

Question 17

Acquisition & Distribution of Pharmaceutical Products, including Samples

In SC, resident (in-state) outsourcing 503b facilities are licensed as:
1. Manufacturers
2. Pharmacies
3. Wholesale distributors
4. Outsourcing facilities
5. Virtual manufacturers

Answer 17

Outsourcing facilities