Experts in the field of USP and FDA compliance in the production and distribution of radiopharmaceuticals for PET imaging.
 

 In the United States, all drug manufacturers must comply with 21 Code of Federal Regulations (CFR) Part 210: Current Good Manufacturing Practice in Manufacturing, Processing, Packing or Holding of Drugs and 21 CFR Part 211: Current Good Manufacturing Practice for Finished Pharmaceuticals.

 In October 2005, the FDA published draft 21 CFR Part 12: Current Good Manufacturing Practice for Positron Emmission Tomography Drug Products. Upon its release, all manufacturers of PET drugs must complywith the new 21 CFR Part 212. It is anticipated that 21 CFR Part 212 will be released and published in the Federal Register by the end of calendar 2006.

 On November 21, 1997 the President signed the Food and Drug Administration (FDA) Modernization Act of 1997 (Public Law 105-115) into law.  Section 121(c)(1)(A) of the Act directed the FDA to establish appropriate approval procedures and Current Good Manufacturing Practices (CGMP) requirements for PET drugs  (Proposed 21 CFR Part 212:  Current Good Manufacturing Practice for Positron Emission Tomography Drugs).

 The FDA’s preliminary draft proposed rule incorporates principles from General Chapter <823>, “Radiopharmaceuticals for Positron Emission Tomography – Compounding”, of the United States Pharmacopeia (USP).

 The USP contains standards that are of significant regulatory importance for PET drugs.  Under section 501(a)(2)(C) of the Modernization Act of 1997, a compounded PET drug is adulterated unless it is produced in compliance with the USP’s PET drug compounding standards and the official monograph for the particular PET drug.

  The staff of Whetstone Associates, Inc. has extensive experience with Positron Emission Tomography and with the production quality assurance and distribution of PET drugs.  One member of our group was directly involved in the development of the first PET cyclotron and in the establishment of the first commercial FDG production and distribution center in the United States in the early 1990s.

 We have successfully submitted Radioactive Material License applications and cyclotron registrations in nine different States.

 We are experienced with the various requirements set forth by the Food and Drug Administration (FDA), the United States Pharmacopeia (USP) and the Code of Federal Regulations (CFR) as they apply to the manufacturing, testing and distribution of PET drugs..

 We are also experienced in  preparing and submitting New Drug Applications for our clients.

 We have successfully brought seven different FDG production facilities into FDA compliance.  This was accomplished by developing documentation (Standard Operating Procedures, Raw Materials Specifications, Quality Manual, Radiation Safety Manual, etc.), implementing comprehensive training programs and conducting thorough compliance audits.