20 CSR 2220-8.010 - Definitions
PURPOSE: This rule adopts definitions for purposes of 20 CSR Chapter 8 governing drug outsourcers and third-party logistics providers.
(1) Definitions.
The following definitions are applicable to 20 CSR 2220 Chapter 8:
(A) "Drug outsourcer" or "Drug outsourcer
facility"- An entity registered with the United States Food and Drug
Administration pursuant to section 503(B) of the federal Food, Drug and
Cosmetic Act, as amended by the Drug Quality and Security Act (21 section USC
353b);
(B) "Drug related device"-An
article that is not considered a prescription drug under federal law, but which
meets the definition of a device as provided in 21 U.S.C. 321(h) and 21 U.S.C.
360j(e);
(C) "Drug" or
"Prescription drug"-A legend drug as defined by section
338.330, RSMo;
and
(D) "Third-party logistics
provider" or "3PL"-An entity that provides or coordinates warehousing, or other
logistics services of a prescription drug or drug-related device on behalf of a
manufacturer, wholesale distributor, or dispenser of such a product, but does
not take ownership of the product, nor has responsibility to direct the sale or
disposition of the product. A third-party logistics provider license is
required for entities conducting 3PL activities that are physically located in
this state or shipping drug products into Missouri.
Notes
State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.
No prior version found.