This week, we will begin looking closer at the "Draft Guidances" for 503A pharmacies. These draft guidances are NOT FINALIZED; when they become finalized, they will represent the current thinking of the FDA on the specific topics.

Copies can be obtained free of charge at the URL listed below. These are "Draft Guidances" and each pharmacist can consider whether or not responding is something they would like to do.

Summary: This draft guidance applies to state-licensed pharmacies, federal facilities, and 503B facilities. There are a number of exceptions to this guidance and includes repackaging drug products for animals and dispensing upon receipt of an individual patient-specific prescription.

The "Background" section covers general repackaging descriptions/examples, regulatory framework for repackaging and hospital and health-system repackaging.

The "Policy" section is divided into the following:

1. General Policy

   The repackaged drug products are generally subject to the adulteration, misbranding, and approval provisions of the FD&C Act. The FDA does not intend to take action for violations 505 and 502(f)(1) if the repackaging is in accordance with the conditions described below, and any applicable requirements. Also, the FDA does not intend to take action for violations of section 501(a)(2)(B) of the FD&C Act if repackaged by a state-licensed pharmacy or a Federal facility in accordance with the conditions described below, and any applicable requirements.

   1-11 Conditions are specifically enumerated to qualify in the document and should be consulted.

2. Repackaging Drugs on FDA's Drug Shortage List

   Specifically addressed is the repackaging of single-dose vials to extend the supply of a drug on the drug shortage list. It covers both approved and unapproved drug products and when the FDA does not intend to take action on violations. It also refers to the draft guidance that will be summarized next week in this Newsletter, "Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application."

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

$9 Billion by 2021: Estimated Market for Compounding Pharmacies Globally
Compounding pharmacies are expected to reach more than $9 billion by 2021 globally, according to a new report published by Market Research Engine. The market is expected to grow at more than a 5% compound annual growth rate during that time. Important factors supporting the growth include rising medicinal shortages of prescription medicines globally, insufficient accessibility to drugs, and an increased cost of branded prescription equivalents.
http://www.digitaljournal.com/pr/3157197

(Editor's Note: This does not appear to include all compounding within hospitals, nuclear pharmacies, and other specialty pharmacies.)

Australian High School Students Recreate Martin Shkreli's High Priced "Daraprim" for $2
Martin Shkreli was widely criticized for hiking the price of a life-saving drug by more than 4,000 percent overnight, to $750 per tablet. Evidently, public outrage reverberated all the way to a high school science lab in Australia, where a group of 11th grade students proceeded to prove a point: that the drug can be made for much, much cheaper. The 11 high school students, ages 16 and 17, successfully recreated the drug, Daraprim, for a mere $2 a pill, according to scientists from the University of Sydney.

Earlier in the year, the students began spending about an hour before and after school working to recreate the drug from a patent, with the help of their science teachers. Their work was posted online periodically allowing scientists to provide them with guidance and feedback. About $15 was spent on the material needed to produce 3.7 grams of Daraprim–about $100,000 worth of the drug in the U.S. market. The drug sample was taken to the University of Sydney to be analyzed where it was found that the students had in fact synthesized pyrimethamine, or Daraprim.
https://www.washingtonpost.com/news/morning-mix/wp/2016/12/01/sydney-high-school-students-show-up-martin-shkreli-recreating-price-hiked-pill-for-2/?utm_term=.82e09a6e8034

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Did You Know ...

�that a number of compounding pharmacies have closed, eliminated sterile compounding, or plan on not handling or carrying any hazardous drugs (HDs) in their pharmacy?

Tip of the Week

Many professions (including pharmacy) are "risk-based," including the requirement of using one's education, training, and professional judgment on handling drugs, etc. For hundreds of years, pharmacists have been handling HDs. Today, why must patients be penalized when a pharmacy closes because the pharmacy only prepares one or two HD compounds a day and cannot afford $50,000 to $100,000 to modify their facility, etc. to do such limited compounding to serve their patients? This is especially true since there have been no prospective, valid, scientific studies showing any dangers from such low-level pharmacy compounding exposure. Individuals in decision-making positions must realize that not everyone lives in a big city with many choices on where to get their prescriptions prepared. The end result is that these poorly written standards will result in patient harm and even death from the lack of patient access to critical medications.

Looking Back

Hit 'em high, Hit 'em low,
Its action rooters crave!
Millions boast - millions toast,
The All-American shave!
     Burma Shave

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