Question

Which of the following circumstances would be considered ""adulteration"" under the FDCA?

a. A drug is prepared and packaged under unsanitary conditions.
b. The drug's manufacturing procedures do not conform to GMP standards.
c. The drug is subject to the Poison Prevention Packaging Act and is not packaged accordingly.
d. a and b
e. a, b and c

Answer 1

The circumstances considered adulteration under the FDCA include preparing and packaging drugs under unsanitary conditions, non-conformance of manufacturing procedures to GMP standards, and non-compliance with the Poison Prevention Packaging Act.

Step-by-step explanation:

Under the FDCA (Food, Drug, and Cosmetic Act), circumstances that would be considered adulteration include:

1. A drug being prepared and packaged under unsanitary conditions.
2. The drug's manufacturing procedures not conforming to GMP (Good Manufacturing Practice) standards.
3. The drug being subject to the Poison Prevention Packaging Act and not being packaged accordingly.

Therefore, the correct answer is e. a, b, and c.