EXAM 3 Rules of the Board 1140-16

Question 1

Third-party logistics providers

Answer 1

-Manufacturers
-Outsourcing facilities (entities that compound sterile products, registered with the FDA)
-Oxygen suppliers
-Wholesalers/Distributors

Third parties logistic providers (3PLs) working on behalf of manufacturers, and wholesalers to store or transport products

Question 2

Company XY is a Third-party logistic provider with 3 entities in TN, how many licenses of the Board does the company need?

Answer 2

3, one for each

Question 3

When does a pharmacy practice site need to register with the board as a distributor?

Answer 3

The dollar volumes of sales shall not exceed 5% of the total med prescription order sales revenue of
EITHER
the transferor or transferee within a 12-month period
(FYI: 5% rule was also seen in the DEA regulations with controlled substances) - here it is based on dollar volume

Question 4

What does a manufacturer provide to the Board?
***

Answer 4

manufacturer:
-results of the FDA inspection
-proof of FDA registration

sterile manufacturer:
-current products manufactured, wholesale, distributed
-provide sterility potency testing contacts (report who is doing the testing)

Question 5

General Operations of manufacturers, outsourcing facilities, oxygen suppliers, and wholesalers/distributor

Answer 5

The facility has to be clean - and need a quarantine area
-Security (must have restricted access)
-Storage: controlled room temperature, documentation of storage

-record-keeping: source, identity, and quantity of drugs, dates of receipt/distribution
keep for 2 years!

Question 6

A sterile product manufacturer/distributor must comply with…

Answer 6

if FDA registered: comply with cGMP

if not FDA-registered: comply with USP standards