Definitions, Properties, and Regulations of Pharmaceuticals

drug compounds

active pharmaceutical ingredient (API) which can come from natural or synthesized sources

dosage forms

a unit containing the API. Ex: tablet, injection, solution.

drug product

dosage forms that has been placed in a container and properly labeled

offical compendia

standards deemed official by the USP are enforceable by the U.S. FDA for medicines manufactured and marketed in the Untied States

United States Pharmacopeia (USP)

drugs dosage forms, and drug products

National formulary (NF)

excipients

value of USP/NF

sets specifications for drugs and products, test conditions, definitions, storage, packaging, etc. Enforceable by law.

general notices

applying to tests, assays, and definitions.

ex: definitions of water and alcohol

general chapters

give information on equipment, procedures, and are referenced from individual monographs.

drug monograph

a publication that contains specific information for a drug (or class of related drugs)

structure (drug monograph component)

chemical name, molecular weight

definition (drug monograph component)

percent of API present (purity)

identification (drug monograph component)

qualitative chemical tests

assay (drug monograph component)

chemical qualification of API

Impurities

specific chemicals and their assay and allowed amounts

dissolution (drug monograph component)

how fast unit releases drug and it dissolves

uniformity of dosage units (drug monograph component)

allowed variation of API content in each dosage form (ex: tablets)

compounding

the process of combining or altering ingredients to prepare a medication by a pharmacist for an individual patient based on a prescription

- preparation cannot be commercially available

Non sterile compounds

ex: oral or topicals

sterile compounds

ex: IV preps or eye drops

non-hazardous, non-sterile compounds

USP 795

hazardous, non-sterile compounds

USP 795 & 800

non-hazardous, sterile compounds

USP 797

hazardous, sterile compounds

USP 797 & 800

non-sterile compounding

primarily used to prepare a dose or formulation that is not commercially available

potable water

drinkable, from the tap; used for hand and equipment washing

purified water

distilled; used for water containing formulations and rising equipment and utensils

sterile compounding

must be conducted with strict procedures to prevent contamination of the drug

sterile hoods for sterile compounding

have horizontal laminar air flow, high efficiency particulate air (HEPA) filters pick up particles when air is passed through the filters in the back to the front

carcinogenic

cancer causing

teratogenic

causes fetal disabilities or malformations or reproductive toxicity

genotoxic

damages DNA, can cause cancer

beyond use date (BUD)

a type of expiration date based on general experimental evidence of drug degradation, microbial contamination, or container failure. only applies to compounded prescriptions in the absence of stability information

BUD with preservative present

35 days

BUD without preservative present

14 days (refigerated)

BUD of Not aqueous, oral liquid

90 days

BUD of aqueous, not oral liquid

180 days