Sterile/Non-sterile Compounding

Question 1

Manufacturing

Answer 1

• Production, preparation, conversion, processing, packaging or labeling of Rx drugs
• Bulk sold to pharmacies, practitioners, etc
• Must follow Current Good Manufacturing Practice (CGMP) regulations)

Question 2

Compounding

Answer 2

• Combining, mixing, or altering ingredients to make a medication for an individual’s needs
• Pharmacist-patient-prescriber relationship (triad)
• Pursuant to valid prescription
• Prior to receiving Rx on the basis of history
• Doesn’t require FDA approval or the following of CGMP requirements

Question 3

FDA’s Compounding Program

Answer 3

• Via the Federal Food, Drug, and Cosmetic Act
• Section 503A - “traditional” compounding by pharmacist or physician
• Section 503B - outsourcing facilities

Question 4

Outsourcing Facilities

Answer 4

• Compounders can apply to become an outsourcing facility
• Drug Quality and Security Act - responded to fungal meningitis outbreak caused by bad compounding
• Section 503B added outsourcing facilities where compounders can distribute to other facilities, must follow CGMP, submit to FDA inspections, and report adverse events to FDA

Question 5

USP

Answer 5

• Non-profit organization that sets standards for variety of compounding topics
• Below <1000> = legally enforceable
• <999> and up = “guidance”
• USP doesn’t enforce the standards, done by the FDA and state BoPs

Question 6

USP Regulations

Answer 6

<795> - non-sterile compounding - updates postponded indefinitely
<797> - sterile compounding
<800> - hazardous substances - 12/1/2020 “informational only”
<825> - radiopharmaceuticals - 12/1/2020 “informational only”

Question 7

Hot Topics in Compounding Ethics

Answer 7

1) Dilution of chemotherapy drugs
2) Development of compounding kits
3) Compounding less-expensive alternatives
4) Compounding & Medicare fraud
5) Compounding of drugs used in lethal injections
6) Distilleries compounding hand sanitizer during COVID

Question 8

Compounding Code of Ethics

Answer 8

Review in Slides
-A lot of parts
Summations
-Don’t sell fraudulent products or spread information about the compounds
-Uphold the triad
-Follow the guidelines set by the BoP and sale compounds per federal and state guidelines
-Give credit to colleagues and share information with them
-Act in the best interest of your patients and don’t deny them based on race, religion, gender, etc.
-Act responsibly and take action to advance the pharmacy profession in developed programs and state/federal associations/assemblies