Glossary


[work in progress]

A

Term
Definition, Expansion, Example
Abbreviated New Drug Application
New Drug Applications for Generics -- smaller due to the non-requisite animal and human clinical data
Active Ingredient
any component that provides pharmacological activity or other direct effect
Active Moiety
all of the active ingredients and their respective quantities
Active Pharmaceutical Ingredient
any substance that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.

B

Blister Pack
is what is displayed on a bubble of plastic for tablets or capsules, which is pushed through. It's usually metallic or cardboard.

C





D

Distributor
A person or group with authority to allot or deal out or apportion (C48289)


E

Establishment


F




G

Generic Drug
Is the same as a brand name drug that has gone off patent
GUID
A GUID is a string of numbers and lower case letters generated using a specifically defined mathematical algorithm to ensure a very low probability of identical GUID used in the same system.

H



I

Importer
Importer means… a company or individual in the United States that is an owner, consignee, or recipient, even if not the initial owner, consignee, or recipient, of the foreign establishment's drug that is imported into the United States. An importer does not include the consumer or patient who ultimately purchases, receives, or is administered the drug, unless the foreign establishment ships the drug directly to the consumer or patient.

J



K



L

Labeler

M

Mandate

Manufacturer
A company involved in the manufacture, preparation, propagation, compounding, or processing of a drug or drugs as used in section 510 of the act and is the making by chemical, physical, biological, or other procedures of any articles that meet the definition of drugs in section 201(g) of the act. The term includes manipulation, sampling, testing, or control procedures applied to the final product or to any part of the process. The term also includes repackaging or otherwise changing the container, wrapper, or labeling of any drug package to further the distribution of the drug from the original place of manufacture to the person who makes final delivery or sale to the ultimate consumer

N

National Drug Code
unique product identifier used in the US for drugs intended for humans.
New Molecular Entity
an active ingredient that has never before been marketed in the United States in any form.

O

Over-the-Counter (OTC)
OTC drugs are:
  • Drugs that do NOT require a doctor's prescription
  • Bought off-the-shelf in stores
  • Regulated by FDA through OTC Drug monographs. OTC drug monographs are a kind of "recipe book" covering acceptable ingredients, doses, formulations, and labeling. Monographs will continually be updated adding additional ingredients and labeling as needed. Products conforming to a monograph may be marketed without further FDA clearance, while those that do not, must undergo separate review and approval through the "New Drug Approval System."

P

Posology
The science of medicinal dosage. A system of dosages

Private Label Distributor
"Private label distributor" or "PLD" means an owner or operator of an establishment not otherwise required to register under section 510 of the Act, but who distributes under its own label or trade name a drug manufactured or processed by a registered establishment. (See 21 CFR 207.20(b))

Q



R

Relabel(er)
Relabeling is to change the label or labels on a drug or drug package, or add to the labeling for a drug or drug package, without repacking the drug or drug package. Note: Relabelers are marketing the product under their own name and NDC numbers. They are independent and not part of the manufacturing process.
Repackager
Companies that repack or repackage or otherwise change the container or wrapper of a drug or drug package and then market the product under their own name and NDC numbers. They are independent and not part of the manufacturing process

S

Sterialize
to effectively kill or eliminate transmissible agents (C84382)

T



U

Unique Ingredient Identifier

US Agent

V



W



X



Y




Z