FDA Guidance and Dietary Supplement GMPs
FDA Investigations Operations Manual FDA Guidance for Industry: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements; Small Entity Compliance Guide 21 CFR PART 111 CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Botanicals to Consider When Deciding Product Coverage, see Attachment E Dietary Supplements-Import and Domestic (Implementation Date: 03/26/2010) includes Pen & Ink Changes as of 07/08/10 to Parts I and II CHAPTER 21 – FOOD COMPOSITION, STANDARDS, LABELING, AND ECONOMICS
by Marian Boardley, Dietary Supplement cGMP Consultant 