This week, we will continue looking at 503A Final Guidance: Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the FFDCA.

Note: An incorrect URL was presented last week; to obtain a free copy of this Guidance, it can be downloaded at:

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatory
Information/Guidances/UCM469120.pdf

2. Background (Continued from last week)
   The following are categories used by the FDA for substances nominated for the 503A bulks list:
   • 503A Category 1-Bulk Drug Substances Under Evaluation
   • 503A Category 2-Bulk Drug Substances That Raise Significant Safety Risks
   • 503A Category 3-Bulk Drug Substances Nominated Without Adequate Support
   
   In its evaluations, the FDA looks at:
   • Physical and chemical characterization of the substance
   • Safety issues
   • Historical use of the substance in compounded drug products
   • Available evidence of effectiveness or lack of effectiveness
   
   
3. Policy  
   1. Compounding from Bulk Drug Substances Under Section 503A

      Until a substance has been evaluated and is identified as being included or not included on the 503A bulks list, FDA does not intend to take action against a state-licensed pharmacy, federal facility or licensed physician compounding a drug product using a bulk drug substance meeting the requirements of the Section, provided that the following conditions are met:

      • The bulk drug substance appears on 503A Category 1 on FDA's website at:
        http://www.fda.gov/downloads/Drugs/GuidanceCompliance
        RegulatoryInformation/PharmacyCompounding/UCM467373.pdf
      • Manufacturers are registered,
      • The bulk drug substance is accompanied by a valid COA, and
      • The compounding is in compliance with all other conditions of Section 503A.
   2. Bulk Drug Substances Not Nominated or Nominated Without Adequate Support
      
      Substances in Category 2 or Category 3 can be re-nominated with sufficient supporting information as well as additional substances can be nominated. The FDA will not evaluate these until after it completes its review of the current Category 1 substances. After completion of the current Category 1 substances, the newly submitted substances will be placed in one of the three categories and will not be subject to the policy allowing compounding until they have been newly categorized.
      
      
   3. Comments about Nominated Bulk Drug Substances
      
      Any disagreement with the categorization of an item you nominated can be addressed as per the Guidance.

APPENDIX: Summary of Policy

Next week, we will complete this Final Guidance by publishing a tabular Summary of the Policy.

Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition

News

FDA Scolds Chinese Active Pharmaceutical Ingredient Maker
The FDA has strongly scolded a Chinese active pharmaceutical ingredient (API) maker in a warning letter for a long list of violations, including:

• hiding questionable products,
• lying to inspectors about products made at the Beijing plant and
• systemic data manipulation.

The warning letter gives the company an action plan for comprehensive improvements that will be required before it can free itself of an FDA ban imposed on the plant last spring. This is just the latest in what has become a steady stream of Chinese drugmakers to be issued warning letters after the FDA increased its presence in China.
http://www.fiercepharma.com/manufacturing/fda-savages-chinese-api-maker-warning-letter

EpiPen-Mylan Scandal, Jet Use, an Unearned MBA and More
Mylan's EpiPen tornado is far from its first storm of controversy. In the last decade, its executives have caught fire for personal use of company aircraft, an unearned degree, outsized compensation, and alleged conflicts of interest. Also, they sued a newspaper for coverage of Mylan production problems.
http://www.fiercepharma.com/pharma/think-epipen-mylan-s-first-scandal-here-s-a-timeline-jet-use-resume-fakery-and-more

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Did You Know ...

�that it seems like we have gone from George Washington's statement "I cannot tell a lie" to today's politicians stating "I cannot tell the truth!"?

Tip of the Week

What a horrible, disappointing example is being portrayed to the world that so much of American politics is based on "lies and corruption." What are the young people and children being taught today? Maybe it's not just in politics�maybe there are other areas (the media, entertainment industry, etc.) of our society that accept lying as "normal"! However, a nation built on lies cannot be sustained.

Also, what would it be like if your physicians and patients lied to you all the time and you based your professional judgment, practice, and license on their lies? We don't generally question the honesty of our prescribers, and we depend upon their truthfulness. Also, regarding our government, we depend upon an honest and truthful government for our security, etc. Something has got to change, regardless of party affiliation!

Looking Back

Avoid the store,
Which claims you should,
Buy something else,
That's just as good!
     Burma Shave