Composition of the USP Pharmacists Pharmacopeia (Cont'd)

Now that we have covered the important General Notices, we will begin looking at the sections that are directly applicable to compounding and pharmacy practice.

We begin with the USP Glossary, or legal definitions.

GLOSSARY

Active Pharmaceutical Ingredient (API): Any substance or mixture of substances intended to be used in the compounding of a drug preparation, thereby becoming the active ingredient in that preparation and furnishing pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans and animals or affecting the structure and function of the body.

Added Substances: Ingredients that are necessary to compound a preparation but are not intended or expected to cause a pharmacologic response if administered alone in the amount or concentration contained in a single dose of the compounded preparation. The term is used synonymously with the terms inactive ingredients, excipients, and pharmaceutical ingredients.

Beyond-Use Date (BUD): The date after which a compounded preparation shall not be used; determined from the date the preparation is compounded.

Component: Any ingredient used in the compounding of a drug preparation, including any active ingredient or added substance that is used in its preparation.

Compounder: A professional authorized by the appropriate jurisdiction to perform compounding pursuant to a prescription or medication order by a licensed prescriber.

Compounding: The preparation, mixing, assembling, altering, packaging, and labeling of a drug, drug-delivery device, or device in accordance with a licensed practitioner's prescription, medication order, or initiative based on the practitioner/patient/pharmacist/compounder relationship in the course of professional practice. Compounding includes the following:

• Preparation of drug dosage forms for both human and animal patients.
• Preparation of drugs or devices in anticipation of prescription drug orders based on routine, regularly observed prescribing patterns.
• Reconstitution or manipulation of commercial products that may require the addition of one or more ingredients.
• Preparation of drugs or devices for the purposes of, or as an incident to, research (clinical or academic), teaching, or chemical analysis.
• Preparation of drugs and devices for prescriber's office use where permitted by federal and state law.

Hazardous Drug: Any drug identified by at least one of the following six criteria:

• Carcinogenicity
• Teratogenicity or developmental toxicity
• Reproductive toxicity in humans
• Organ toxicity at low doses in humans or animals
• Genotoxicity
• New drugs that mimic existing hazardous drugs in structure or toxicity [for examples see current National Institute for Occupational Safety and Health (NIOSH) publications].

Manufacturing: The production, propagation, conversion, or processing of a drug or device, either directly or indirectly, by extraction of the drug from substances of natural origin or by means of chemical or biological synthesis. Manufacturing may also include any packaging or repackaging of the substance(s) or labeling or relabeling of containers for resale by pharmacies, practitioners, or other persons.

Preparation: For the purposes of this chapter, a compounded drug dosage form or dietary supplement or a device to which a compounder has introduced a drug. This term will be used to describe compounded formulations; the term product will be used to describe manufactured pharmaceutical dosage forms. (For the definitions of official substance and official products, see General Notices and Requirements.)

Stability: The extent to which a preparation retains, within specified limits and throughout its period of storage and use, the same properties and characteristics that it possessed at the time of compounding (see Stability Considerations in Dispensing Practice within the table Criteria for Acceptable Levels of Stability).

Vehicle: A component for internal or external use that is used as a carrier or diluent in which liquids, semisolids, or solids are dissolved or suspended. Examples include, but are not limited to, water, syrups, elixirs, oleaginous liquids, solid and semisolid carriers, and proprietary products.

Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition

Did You Know (On Homework) ...

The following...

Teacher: "Did your father help you with the problem"
Tommy: "No, I got it wrong myself."

Susan: "That problem you helped me with last night was all wrong, Daddy.
Father: "All wrong was it, well I'm sorry.
Susan: "Well you needn't exactly worry about it because none of the other fathers got it right either."

Join the CNL!

IJPC would like to invite all compounding pharmacists and technicians to join the Compounders' Network List (CNL) - an e-mail-based resource for sharing compounding information with your peers.

Go to the following website for more information and to join.

https://ijpc.com/cnl

From Out of the Past

The draftee
Tried a tube
And purred
Well whaddya know
I've been defurred!
     Burma-Shave