Ch 19 P 9 Minimum Standards for Manufacturers and Repackaging firms Flashcards Preview

NM MPJE > Ch 19 P 9 Minimum Standards for Manufacturers and Repackaging firms > Flashcards

Flashcards in Ch 19 P 9 Minimum Standards for Manufacturers and Repackaging firms Deck (5)
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1

Manufacturer

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.

2

Manufacturers

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

3

Packager or Packer

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

4

Distributor

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

5

The finished dosage form

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.

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