Ch 19 P 9 Minimum Standards for Manufacturers and Repackaging firms

Question 1

Manufacturer

Answer 1

The steps in the preparation, propagation, processing or compounding of a drug - the making by chemical, physical, biological or other procedures of any articles which meet the definition of drugs and includes manipulation, sampling or control procedures resulting in the finished dosage form. Manufacture includes all the steps performed on the product itself, which do not affect intrinsically the safety, purity or potency of the product.

Question 2

Manufacturers

Answer 2

The person or company that manufactures a drug in its’ finished dosage form.

Question 3

Packager or Packer

Answer 3

A person or firm, other than a wholesaler, who distributes drugs.

Question 4

Distributor

Answer 4

The original selling agent, other than a wholesaler, who distributes drugs.

Question 5

The finished dosage form

Answer 5

A prescription drug is defined as that form of the drug which is or is intended to be dispensed or administered to the patient and requires no further manufacturing or processing other than packaging and labeling.