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Flashcards in Compounding Deck (12)
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1

FDA Definition of Compounding

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

Compounding includes...

-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

Compounding DOESN'T include...

-Copying commercially available products
-Minor, insignificant changes in formulation
-Bulk preparation without documentation of need

4

Recent History

-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

US Pharmacopeia

-Not a legal entity
-Sets standards of drug identity, strength, quality, and purity
-Standards must be met to avoid misbranding or adulteration

6

USP Components

-Monographs
-Chapters

7

Monographs

-Name of ingredient/preparations, definition, packaging, storage, and labeling requirements
-Specifications for testing

8

Chapters

-Detail for tests/procedures in monographs
-Chapters under <1000> enforceable by FDA and BoP

9

USP <797>

-Sterile Preparation Compounding regulations
-Newest revision effective December 1, 2019
-Enforceable by BoP
-Revised regulations from BoP
-Regulation: NMAC 16.19.36

10

USP <795>

-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

USP <800>

-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

USP <825>

-Radiopharmaceutical regulations
-Specific to radioactive drugs
-Effective December 1, 2019
-Considers radiation in procedures
-Enforceable by BoP
-Revised regulations by BoP