Industry Terms Glossary

D

Digital Signature

An electronic signature based upon cryptographic methods of originator authentication, computed by using a set of rules and a set of parameters such that the identity of the signer and the integrity of the data can be verified.

Distribute

To sell, offer to sell, deliver, or offer to deliver a drug to a recipient, except that the term "distribute" does not include: (1) Delivering or offering to deliver a drug by a common carrier in the usual course of business as a common carrier; or (2) Providing of a drug sample to a patient by: (i) A practitioner licensed to prescribe such drug; (ii) A health care professional acting at the direction and under the supervision of such a practitioner; or (iii) The pharmacy of a hospital or of another health care entity that is acting at the direction of such a practitioner and that received such sample in accordance with the act and regulations.

Drug Coupon

A form that may be redeemed, at no cost or at reduced cost, for a drug that is prescribed in accordance with section 503(b) of the act.

Drug Product

A finished dosage form, e.g., tablet, capsule, or solution, that contains an active drug ingredient, generally, but not necessarily, in association with inactive ingredients. For purposes of this part, drug product also means biological product within the meaning of section 351(a) of the Public Health Service Act.

Drug Product Salvaging

The act of segregating drug products that may have been subjected to improper storage conditions, such as extremes in temperature, humidity, smoke, fumes, pressure, age, or radiation, for the purpose of returning some or all of the products to the marketplace.

Drug Sample

A unit of a prescription drug that is not intended to be sold and is intended to promote the sale of the drug.