Compounding Flashcards
1
Q
FDA Definition of Compounding
A
A licensed pharmacist, physician, or person under pharmacy supervision combined, mixes, or alters ingredients of a drug to create a medication tailored to need of individual patients
2
Q
Compounding includes…
A
- Reconstitution of FDA approved products
- Mixing IV solutions
- Reformulating drugs to exclude unwanted, unneeded ingredients like lactose, gluten, or a dye to which the patient is allergic
- Change formulation of medication based in patient need
3
Q
Compounding DOESN’T include…
A
- Copying commercially available products
- Minor, insignificant changes in formulation
- Bulk preparation without documentation of need
4
Q
Recent History
A
- 2012: New England Compounding Center Incident
- 2013: Drug Quality and Security Act passed by Congress which allows state-licensed pharmacies to compound patient specific prescriptions and defines outsourcing facility compounding product in bulk without Rx
5
Q
US Pharmacopeia
A
- Not a legal entity
- Sets standards of drug identity, strength, quality, and purity
- Standards must be met to avoid misbranding or adulteration
6
Q
USP Components
A
- Monographs
- Chapters
7
Q
Monographs
A
- Name of ingredient/preparations, definition, packaging, storage, and labeling requirements
- Specifications for testing
8
Q
Chapters
A
- Detail for tests/procedures in monographs
- Chapters under <1000> enforceable by FDA and BoP
9
Q
USP <797>
A
- Sterile Preparation Compounding regulations
- Newest revision effective December 1, 2019
- Enforceable by BoP
- Revised regulations from BoP
- Regulation: NMAC 16.19.36
10
Q
USP <795>
A
- Nonsterile Preparation Regulations
- Revision effective December 1, 2019
- Enforceable by BoP
- New regulations from BoP
- New training requirements, segregated compounding area, SOP, expanded BUD requirements
11
Q
USP <800>
A
- Hazardous Drugs in healthcare settings
- New chapter - specific to hazardous drugs listed in NIOSH
- Effected December 2019
- Intended to minimize exposure to hazardous drugs in HC settings
- New regulations from BoP
12
Q
USP <825>
A
- Radiopharmaceutical regulations
- Specific to radioactive drugs
- Effective December 1, 2019
- Considers radiation in procedures
- Enforceable by BoP
- Revised regulations by BoP
