This week, we will look at the first part of the remaining 503A FINAL Guidances: Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the FFDCA. You are strongly encouraged to obtain a copy of this Guidance which can be downloaded at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatory
Information/Guidances/UCM469119.pdf

1. Introduction and Scope
   Section 503A of the FD&C Act includes certain restrictions on bulk drug substances that can be used in compounding. It also directs the FDA to develop a list of these that can be used in compounding, utilizing the Pharmacy Compounding Advisory Committee.
   
   
2. Background
   1. Compounding from Bulk Drug Substances Under Section 503A of the Act.
      To qualify for compounding, bulk drug substances:
      1. Must comply with the standards of a USP or NF monograph, if one exists.
      2. If such a monograph does not exist, are components of approved drugs.
      3. If neither of the above, then they must appear on a list developed by the Secretary through regulations issued by the Secretary.
      
      Note: The FDA does not consider USP monographs for dietary supplements to be "applicable" USP or NF monographs.
      
      
   2. Efforts to Develop the List of Bulk Drug Substances Under Section 503A.
      In response to the December 2013 Federal Register notice, over 2,000 substances were nominated for the 503A Bulks List. Of these:
      • Approximately 740 unique substances were nominated. Of these:
      • Approximately 315 are already eligible for use under section 503A.
      • At least one is not a bulk drug substance. At least one is considered a biological product.
      • At least four appear on the "not to compound" or the "negative" list.
      • One has no currently accepted medical use and is a Schedule I CSA.
      • Approximately 350 substances were nominated with insufficient supporting evidence for FDA to evaluate them.
      • The remaining substances may be eligible for inclusion as they were nominated with sufficient supporting information for evaluation.
      
      NOTE: THIS WILL BE CONTINUED NEXT WEEK
      
      
3. Policy
   1. Compounding from Bulk Drug Substances Under Section 503A
   2. Bulk Drug Substances Not Nominated or Nominated Without Adequate Support
   3. Comments about Nominated Bulk Drug Substances

   APPENDIX: Summary of Policy

Next week, we will continue on this Final Guidance for 503A compounding.

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

DOJ Demands Information on Pharma Deals from Express Scripts
Congressional pharma critics are starting to investigate pharmacy benefit managers. Turns out the U.S. Justice Department already had one of the industry's largest under a microscope. Express Scripts has disclosed that the U.S. Attorney's offices in New York and Massachusetts had demanded information about two different issues: 1) financial ties with pharma companies, and 2) relationships among drugmakers, patient assistance programs, and the specialty pharmacies that fill prescriptions. Specifically requested is information about money changing hands between Express Scripts and pharma companies, including rebates that drugmakers pay to win favorable reimbursement deals for their products.
http://www.fiercepharma.com/pharma/doj-turns-tables-express-scripts-demands-info-pharma-deals

Interpharm's Czech Plant Gets FDA Warning Letter
A Czech drugmaker that ships both active pharmaceutical ingredients and finished products to the U.S. has come under fire from the FDA in a warning letter for data integrity issues. It lists about a dozen steps it wants the company to take to improve its systems. There is a lack of controls and routine purging of data by analysts; the company's quality-control unit does not have all of the information it needs to make informed decisions about whether products are safe and effective and meet U.S. standards.
http://www.fiercepharma.com/manufacturing/interpharm-gets-fda-warning-letter-for-czech-plant

Chinese Pharmaceutical Plants Slammed by FDA
Two Chinese companies with ties to Western drugmakers have been called on the mat to account for problems in their manufacturing plants. Shanghai Desano Chemical Pharmaceutical and Chongqing Lummy Pharmaceutical were caught manipulating testing and turning in falsified batch test results on active pharmaceutical ingredients. The FDA found 8,400 unofficial chromatographic analyses at the Desano plant. The FDA states that all data needs to be reviewed by the plant's quality unit before deciding whether to release batches. The FDA also found many electronic logs of production deviations in a folder titled "GMP Anomalies" that had never been investigated.
http://www.fiercepharma.com/manufacturing/fda-slams-two-chinese-drugmakers-warning-letters

Perrigo to Sell Active Pharmaceutical Ingredients Plant in India
Ireland-based drugmaker Perrigo put its active pharmaceutical ingredient plant in Ambernath, India on the block earlier this year to reduce its growing debt; the facility has a capacity to manufacture about 600,000 tonnes (661,000 U.S. tons) of active pharmaceutical ingredients a year.
http://www.fiercepharma.com/manufacturing/ireland-s-perrigo-looking-to-shed-api-plant-india-to-reduce-debt

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Did You Know ...

�that when you see headlines stating "xyz compounder slapped with FDA warning letter," most think that it is the 503a neighborhood compounding pharmacies that are in trouble? However, upon further checking, it is often the 503b manufacturing outsource facilities that have been issued the '483s, but this fact is not mentioned. For a current list of the Registered Outsourcing Facilities, go to:
http://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/
pharmacycompounding/ucm378645.htm

Tip of the Week

We must read carefully and check things out. There is so much "misrepresentation" and "partial/incomplete information" in news articles today that one sometimes wonders if they are worth reading! The sad thing is that the public does not know the difference, and pharmacy suffers another potential black eye.

Looking Back

Heaven's latest,
Neophyte,
Signaled left,
Then turned right.
     Burma Shave