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1. Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act

2. Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act

3. Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act

4. Hospital and Health System Compounding Under the Federal Food, Drug, and Cosmetic Act

5. Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act

6. Section 503A, Federal Food, Drug, and Cosmetic Act

USP General Chapters: Various chapters that set standards for chemical and biological drug substances, dosage forms, and compounded preparations. Examples include:

USP <795>: Pharmaceutical Compounding – Nonsterile Preparations.

USP <797>: Pharmaceutical Compounding – Sterile Preparations.

USP <800>: Handling of Hazardous Drugs in Healthcare Settings.

USP Monographs: Specific monographs for individual drug substances and ingredients, describing tests, procedures, and acceptance criteria.

1. Insanitary Conditions: Insanitary Conditions at Compounding Facilities

2. Fees for 503B FDA Registration: Fees for Human Drug Compounding Outsourcing Facilities Under Sections 503B and 744K of the FD&C Act

3. 503B Facility Definition: Facility Definition Under Section 503B of the Federal Food, Drug, and Cosmetic Act

4. CGMP Guidance for 503B: Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act

5. 503B Bulks Background: Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act

6. Bulks Nominated for Use in 503B: Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act

7. Essential Copy Guidance: Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act

8. Repackaging Guidance: Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities

9. Limitations on Mixing, Diluting, Repacking Biologics:  Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application

10. Product Reporting for 503B: Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act

1. Title 21 CFR Part 1301: Registration of Manufacturers, Distributors, and Dispensers of Controlled Substances.

2. Title 21 CFR Part 1302: Labeling and Packaging Requirements for Controlled Substances. 

3. Title 21 CFR Part 1306: Prescriptions for Controlled Substances.

1. 21 CFR Part 11: Electronic Records; Electronic Signatures

2. 21 CFR Part 50: Protection of Human Subjects

3. 21 CFR Part 56: Institutional Review Boards (IRBs)

4. 21 CFR Part 58: Good Laboratory Practice for Nonclinical Studies

5. 21 CFR Part 201: Labeling Requirements for Drugs and Biologics

6. 21 CFR Part 202: Prescription Drug Advertising

7. 21 CFR Part 210: Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General

8. 21 CFR Part 211: Current Good Manufacturing Practice for Finished Pharmaceuticals

9. 21 CFR Part 312: Investigational New Drug Application (IND)

10. 21 CFR Part 314: Applications for FDA Approval to Market a New Drug or an Antibiotic Drug.

11. 21 CFR Part 600: Biological Projects: General

12. 21 CFR Part 601: Biologics License Applications (BLA)

13. 21 CFR Part 610: General Biological Product Standards

14. 21 CFR Part 820: Quality System Regulation

15. 21 CFR Part 1271: Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)

16. Section 351, Public Health Service Act

17. Section 503B, Federal Food Drug & Cosmetic Act

ICH Q1A-Q14: Harmonization achievements in the Quality area include pivotal milestones such as the conduct of stability studies, defining relevant thresholds for impurities testing and a more flexible approach to pharmaceutical quality based on Good Manufacturing Practice (GMP) risk management.