Question

question 36

a pharmacy technician should recognize that the drug supply chain security act (dscsa) was enacted primarily to achieve which of the following goals?

to set expiration date requirements for all pharmaceutical products.
to regulate advertising of prescription drugs to consumers.
to establish the dea scheduling system for controlled substances.
to create an interoperable system to track and trace prescription drugs through the supply chain.

Explanation:

Identify the core purpose of the DSCSA

The Drug Supply Chain Security Act (DSCSA), enacted by Congress in 2013 as part of the Drug Quality and Security Act (DQSA), outlines steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States.

Evaluate the given options

• Option 1: "To set expiration date requirements for all pharmaceutical products." This is incorrect; expiration dating is regulated under general FDA Good Manufacturing Practices (GMP) and USP standards.
• Option 2: "To regulate advertising of prescription drugs to consumers." This is incorrect; Direct-to-Consumer (DTC) advertising is regulated by the FDA's Division of Drug Marketing, Advertising, and Communications (DDMAC) / Office of Prescription Drug Promotion (OPDP).
• Option 3: "To establish the DEA scheduling system for controlled substances." This is incorrect; the scheduling system was established by the Controlled Substances Act (CSA) of 1970.
• Option 4: "To create an interoperable system to track and trace prescription drugs through the supply chain." This is correct, as the primary goal of the DSCSA is to protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful by implementing "track and trace" requirements.

Answer:

• (A) To set expiration date requirements for all pharmaceutical products.
• (B) To regulate advertising of prescription drugs to consumers.
• (C) To establish the DEA scheduling system for controlled substances.
• (D) To create an interoperable system to track and trace prescription drugs through the supply chain. (Correct answer)