Pharmaceutics Exam 3 (Lecture 29, Intro to compounding regs)

Compounding

Preparation, mixing, assembling, packaging, and labeling of a drug or device tailored to the needs of the patient when a commercially available drug does not meet those needs.

Pharmacists can compound when:

• Drug shortage

• Patient can’t tolerate excipients

• Alternative dosage form

Federal Food Drug & Cosmetic Act (FD&C)

• Quality Standards

• Federal Oversight & Enforcement

• Does NOT refer to compounding

• Only Manufactured (FDA Approved) Drugs

USP

Standards for compounded and manufactured pharmaceutical products.

National Formulary (NF)

Standards for excipients.

Drug Quality & Security Act

• Created in response to 2012 fungal meningitis outbreak

• Updated FD&A:

  • Compounding Quality Act (CQA)

  • Drug Supply Chain Security Act (DSCSA)

503A

• Refers to Traditional Compounding Pharmacies

• Under FD&C Act

• Compounded Drugs except from several FDA Requirements

• Proper Labeling w/ directions

• Follow cGMP

• Prohibits compounders from advertising, promoting, and soliciting prescriptions (no competition with manufacturers)

• Can only compound with a provided specific prescription for patient

• Must Comply With USP 795 & 797

503B

• Refers to Outsourcing Facilities

• Must Register with FDA and get inspected

• Labeling Requirments

• Can compound with or without script

• Office use in large batches

• Must Comply With USP 795 & 797

• Follow cGMP

• Not usually a licensed pharmacy

• Need Supervision of licensed pharmacist/physician

• Can’t Compound commercially Available products unless there is a shortage

Manufacturing

• No RX

• Drug for resale

• Regulated by FDA

• Follow cGMP

• Expiration dates

• No pharmacist or pharmacy license

Are Compounded Drugs FDA Approved?

NO

Who inspects facilities that compound drugs?

State Board of Pharmacy (SBoP)

Who Inspects 503B? (Outsourcing Facilities)

FDA

Who Inspects 503A? (Traditional Compounding)

FDA has authority to inspect

Who can compound?

• Physician

• Licensed Pharmacists

• Under Supervision of Pharmacist

What Substances may be used in compounding?

• Bulk Drug substances that have a monograph in USP/NF and comply w/ USP 795

• Bulk Drug substances that are on a list of approved drugs from FDA

• Drug Substances that are components of FDA-approved and drug products

• Substances that are manufactured by facilities registered w/ FDA

• Commercial products that need to be modified for a patient

What substances may NOT be used in compounding?

• Withdrawn/removed drug products

• Biologics

• Making products that are copies of FDA approved drugs

• Any competing medication with a manufacterer

USP 795

Nonsterile Compounding Standards

USP 797

Sterile Compounding Standards

USP 800

Hazardous Drug Standards

USP 1168

Phase 1 Investigational Studies

USP 1163

Quality Assurance