Sterile and Non sterile Compounding - Dr. Herman

Question 1

Manufacturing

Answer 1

• Product production
• Larger scale
• Commercially available products for bulk resale
• Must follow Current Good Manufacturing Practice (CGMP)

Question 2

Compounding

Answer 2

• Making drugs for individual patient
• Pharmacist, patient, prescriber relationship (triad)
• Pursuant to a valid prescription
• Does NOT require FDA approval
• Does not need to adhere to CGMP requirements

Question 3

Section 503A

Answer 3

-Traditional compounding by pharmacist of physician

Question 4

Section 503B

Answer 4

• Outsourcing facilities
• Middle ground
• Drug Quality and Security Act (DQSA)
• May distribute to other facilities
• Must follow CGMP
• Submit to FDA for inspection

Question 5

Drug Quality and Security Act (DQSA)

Answer 5

• 2012 fungal meningitis outbreak caused by poor compounding
• Higher standard for 503B than for 503A

Question 6

USP 795

Answer 6

• Non sterile compounding

Question 7

USP 797

Answer 7

-Sterile compounding

Question 8

USP 800

Answer 8

-Hazardous substances

Question 9

Chapters below 1000 vs greater than 999

Answer 9

• Below 1,000 = legally enforceable

- Above 999 = “Guidance”

Question 10

Who creates and enforces the USP standards

Answer 10

• Created by USP

- Enforced by FDA or NMBoP

Question 11

Compounding Pharmacists Code of Ethics

Answer 11

• Uphold the triad
• Operate within state laws
• Practice with competence and integrity
• Work within your expertise
• Seek continuing education that enhances my practice