Final Rule for cGMP for Dietary Supplements

Current Good Manufacturing Practice for Dietary Supplements

On June 25, 2007, FDA published in the Federal Register a final rule that established a regulation (21 CFR part 111) entitled Current Good Manufacturing Practice (CGMP) In Manufacturing, Packaging, Labeling, Or Holding Operations For Dietary Supplements (72 FR 34752).

The Dietary Supplement (DS) CGMP rule in 21 CFR part 111 (“the DS CGMP rule”) requires persons who manufacture, package, label, or hold a dietary supplement to establish and follow current good manufacturing practice to ensure the quality of the dietary supplement and to ensure that the dietary supplement is packaged and labeled as specified in the master manufacturing record.

Download 21 CFR Part 111

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In the same issue of the Federal Register (72 FR 34959), FDA also issued an interim final rule (the identity testing interim final rule) setting forth a procedure for requesting an exemption from a requirement of the DS CGMP rule for the manufacturer to conduct at least one appropriate test or examination to verify the identity of any dietary ingredient that is a component of a dietary supplement.

Download Interim Final Rule for Requesting an Exemption

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The provisions of the identity testing interim final rule have the full force of law, but FDA provided a 90-day comment period on those provisions through September 24, 2007. On September 17, 2007, FDA published a notice in the Federal Register to extend the comment period to October 24, 2007.

The DS CGMP rule and the identity testing interim final rule were effective as of August 24, 2007. The compliance dates are described below.

FDA has prepared this Small Entity Compliance Guide in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121). This guidance document restates in plain language the legal requirements set forth in the DS CGMP rule (21 CFR part 111). The DS CGMP rule is binding and has the full force and effect of law.

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

Table of Contents

  1. Introduction
  2. Discussion
    1. Compliance Dates for the Dietary Supplement Current Good Manufacturing Practice Rule (DS CGMP Rule) and the Interim Final Rule
    2. Organization for the DS CGMP Rule
  3. Subpart A – General Provisions
    1. Coverage of the DS CGMP Rule
    2. How the DS CGMP Rule Applies to Specific Types of Operations
    3. How the DS CGMP Rule Applies to Contractors
    4. Terms Used in the DS CGMP Rule and In This Document
    5. Other Applicable Statutory Provisions and Regulations
  4. Written Procedures Required by the DS CGMP Rule
  5. Records Required by the DS CGMP Rule
  6. Subpart B – Personnel
  7. Subpart C – Physical Plant And Grounds
  8. Subpart D – Equipment And Utensils
  9. Subpart E – Requirement To Establish A Production And Process Control System
    1. General Requirements of Subpart E
    2. Requirements to Establish Specifications
    3. Requirements to Determine Whether Specifications Are Met
    4. Specific Requirements Regarding Specifications for Dietary Ingredients and Other Components
    5. Representative and Reserve Samples
  10. Subpart F – Production and Process Control: Requirements For Quality Control
  11. Subpart G – Production and Process Control: Requirements For Components, Packaging, And Labels And For Product That Is Received For Packaging Or Labeling As A Dietary Supplement
    1. Requirements for Components
    2. Requirements for Packaging and Labels
    3. Requirements for Received Product
    4. Requirements for Rejected Components, Packaging, Labels and Received Product
  12. Subpart H – Production and Process Control: Requirements for a Master Manufacturing Record
  13. Subpart I – Production and Process Control: Requirements for a Batch Production Record
  14. Subpart J – Production and Process Control: Requirements for Laboratory Operations
  15. Subpart K – Production and Process Control: Requirements for Manufacturing Operations
  16. Subpart L – Production and Process Control: Requirements for Packaging and Labeling Operations
  17. Subpart M – Holding and Distributing
  18. Subpart N – Returned Dietary Supplements
  19. Subpart O – Product Complaints
  20. Subpart P –Records and Recordkeeping
  21. References

Download FDA Guidance

Questions and Answers on Dietary Supplements

2010-FDA cGMP for Dietary Supplements

OR

Download “FDA cGMP Guidance for Dietary Supplements” 2010-FDA-cGMP-for-Dietary-Supplements.pdf – Downloaded 349 times – 641 KB

Last Updated: 2015-09-11