Biomaterial Database

Implementing United States Pharmacopeia Chapter <1163>: Quality assurance in pharmaceutical compounding, part 4: cleaning and packaging. 2012

Loyd V Allen

lallen@ijpc.com

Many of the General Chapters within United States Pharmacopeia Chapter <1163> were written for the pharmaceutical industry. However, much of the information within that Chapter is appropriate for use in compounding pharmacy. This article specifically discusses guidelines as they pertain to Cleaning, Disinfecting, and Safety, which includes a discussion on the selection of disinfectants and antiseptics, and discusses the guidelines that pertain to Containers, Packaging, Repackaging, Labeling, and Storage, which includes a brief discussion on some of the specifics on these topics.

UI	MeSH Term	Description	Entries
D010602	Pharmacopoeias as Topic	Works about authoritative treatises on drugs and preparations, their description, formulation, analytic composition, physical constants, main chemical properties used in identification, standards for strength, purity, and dosage, chemical tests for determining identity and purity, etc.	Formulary, National,National Formulary,Formularies, National,National Formularies
D004202	Disinfectants	Substances used on inanimate objects that destroy harmful microorganisms or inhibit their activity. Disinfectants are classed as complete, destroying SPORES as well as vegetative forms of microorganisms, or incomplete, destroying only vegetative forms of the organisms. They are distinguished from ANTISEPTICS, which are local anti-infective agents used on humans and other animals. (From Hawley's Condensed Chemical Dictionary, 11th ed)	Biocide,Disinfectant,Biocides
D004203	Disinfection	Rendering pathogens harmless through the use of heat, antiseptics, antibacterial agents, etc.
D004339	Drug Compounding	The preparation, mixing, and assembly of a drug. (From Remington, The Science and Practice of Pharmacy, 19th ed, p1814).	Drug Formulation,Drug Preparation,Drug Microencapsulation,Pharmaceutical Formulation,Compounding, Drug,Formulation, Drug,Formulation, Pharmaceutical,Microencapsulation, Drug,Preparation, Drug
D004348	Drug Labeling	Use of written, printed, or graphic materials upon or accompanying a drug container or wrapper. It includes contents, indications, effects, dosages, routes, methods, frequency and duration of administration, warnings, hazards, contraindications, side effects, precautions, and other relevant information.	Labeling, Drug,Package Inserts, Drug,Product Labeling, Drug,Black Box Warning,Boxed Warning,Drug Labelling,Black Box Warnings,Box Warning, Black,Box Warnings, Black,Boxed Warnings,Drug Package Insert,Drug Package Inserts,Drug Product Labeling,Insert, Drug Package,Inserts, Drug Package,Labeling, Drug Product,Labelling, Drug,Package Insert, Drug,Warning, Black Box,Warning, Boxed,Warnings, Black Box,Warnings, Boxed
D004349	Drug Packaging	Containers, packaging, and packaging materials for drugs and BIOLOGICAL PRODUCTS. These include those in ampule, capsule, tablet, solution or other forms. Packaging includes immediate-containers, secondary-containers, and cartons. In the United States, such packaging is controlled under the Federal Food, Drug, and Cosmetic Act which also stipulates requirements for tamper-resistance and child-resistance. Similar laws govern use elsewhere. (From Code of Federal Regulations, 21 CFR 1 Section 210, 1993) DRUG LABELING is also available.	Drug Containers and Closures,Packaging, Drug,Drug Containers,Container, Drug,Containers, Drug,Drug Container,Drug Packagings,Packagings, Drug
D004356	Drug Storage	The process of keeping pharmaceutical products in an appropriate location.	Drug Storages,Storage, Drug,Storages, Drug
D000891	Anti-Infective Agents, Local	Substances used on humans and other animals that destroy harmful microorganisms or inhibit their activity. They are distinguished from DISINFECTANTS, which are used on inanimate objects.	Anti-Infective Agents, Topical,Antiseptic,Antiseptics,Microbicides, Local,Microbicides, Topical,Antiinfective Agents, Local,Antiinfective Agents, Topical,Local Anti-Infective Agents,Local Antiinfective Agents,Topical Anti-Infective Agents,Topical Antiinfective Agents,Agents, Local Anti-Infective,Agents, Local Antiinfective,Agents, Topical Anti-Infective,Agents, Topical Antiinfective,Anti Infective Agents, Local,Anti Infective Agents, Topical,Local Anti Infective Agents,Local Microbicides,Topical Anti Infective Agents,Topical Microbicides
D014481	United States	A country in NORTH AMERICA between CANADA and MEXICO.