Compounding

Question 1

FDA Definition of Compounding

Answer 1

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

Question 2

Compounding includes…

Answer 2

• 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

Question 3

Compounding DOESN’T include…

Answer 3

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

Question 4

Recent History

Answer 4

• 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

Question 5

US Pharmacopeia

Answer 5

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

Question 6

USP Components

Answer 6

• Monographs

- Chapters

Question 7

Monographs

Answer 7

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

Question 8

Chapters

Answer 8

• Detail for tests/procedures in monographs

- Chapters under <1000> enforceable by FDA and BoP

Question 9

USP <797>

Answer 9

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

Question 10

USP <795>

Answer 10

• 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

Question 11

USP <800>

Answer 11

• 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

Question 12

USP <825>

Answer 12

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