Drug Compliance Programs

FDA compliance programs provide guidance and instructions to FDA staff for obtaining information to help fulfill agency plans in the specified program area. These compliance programs neither create or confer any rights for, or on, any person and do not operate to bind FDA or the public. Alternative approaches may be used as long as said approaches satisfy the requirements of applicable statutes and regulations. These programs are intended for FDA personnel but are made available electronically to the public as they become available.

The FDA Compliance Program Guidance Manual listing is available at Compliance Program Guidance Manual

Program No.Compliance Program Title
7348.003In Vivo Bioavailability-Bioequivalence Studies – Clinical
7348.004 In Vivo Bioavailability-Bioequivalence Studies – Analytical
7348.809ARadioactive Drug Research Committee (PDF - 142KB)
7346.832Pre-Approval Inspections/Investigations (PDF - 406KB)
7346.843Post-Approval Audit Inspections (PDF - 152KB)
7352.002Unapproved New Drugs (Marketed, Human, Prescription Drugs only) (PDF - 52KB)
[HTML version]
7352.004In Vitro Methods Development and Validation for Generic Drugs
(Not available online)
7353.001Postmarketing Adverse Drug Experience (PADE) Reporting Inspections
7356.002Drug Manufacturing Inspections (PDF - 160KB) 
7356.002ASterile Drug Process Inspections (PDF - 292KB)
7356.002BDrug Repackers and Relabelers (PDF - 182KB)
7356.002CRadioactive Drugs (PDF - 180KB)
7356.002ECompressed Medical Gases (PDF - 239KB)
7356.002FActive Pharmaceutical Ingredients (PDF - 150 KB)
7356.002MInspections of Licensed Biological Therapeutic Drug Products (PDF - 93KB)
[HTML version]
7356.002PPositron Emission Tomography (PDF - 183KB)
7356.008Drug Quality Sampling and Testing - Human Drugs
7356.014Drug Listing
(Not available online)
7356.014ADrug Listing - Labeling Review
(Not available online)
7356.020Compendial Monographs Evaluation and Development (CMED)
(Not available online)
7356.020ACompendial Methods Assessment
(Not available online)
7356.021Drug Quality Reporting System (DQRS) (MedWatch Reports) NDA Field Alert Reporting (FARs)
7356.022Enforcement of the Drug Sample Distribution Requirements of the Prescription Drug Marketing Act (PDMA)
7361.003OTC Drug Monograph Implementation (PDF - 51KB)
7363.001Fraudulent Drugs (PDF - 68KB)


More in Guidance, Compliance & Regulatory Information

Good Review Practices (GRPs)

Page Last Updated: 03/19/2019
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