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Editorial: Difficult to Compound, Part I

This is the thirteenth in the series looking at various aspects of the new H.R. 3204 Drug Quality and Safety Act. This week we will introduce the "difficult to compound" list and associated considerations of the first Pharmacy Compounding Advisory Committee (PCAC) during 1998, 1999, and 2000.

The following questions were asked of the PCAC on the July 13-14, 2000 meeting.

Do you agree that the following are the appropriate factors to use in evaluating drug products or categories of drug products to determine if they should be included on the difficult to compound list?

1. Drug delivery system: Is a sophisticated drug delivery system required to ensure dosing accuracy and/or reproducibility? Is the safety or efficacy of the product a concern if there is product-to-product variability?
2. Drug formulation and consistency: Is a sophisticated formulation of the drug product required to ensure dosing accuracy and/or reproducibility? Because of the sophisticated formulation, is product-to-product uniformity of the drug product often difficult to achieve? Is the safety or efficacy of the product a concern if there is product-to-product variability?
3. Bioavailability: Is it difficult to achieve and maintain a uniformly bioavailable dosage form? Is the safety or effectiveness of the product a concern if the bioavailability varies?
4. Complexity of compounding: Is the compounding of the drug product complex? Are there multiple, complicated or interrelated steps? Is there a significant potential for error in one or more of the steps that could affect drug safety or effectiveness?
5. Facilities and equipment: Are sophisticated facilities and/or equipment required to ensure proper compounding of the drug product? Is there a significant potential for error in the use of the facilities or equipment that could affect drug safety or effectiveness?
6. Training: Is specialized, highly technical training essential to ensure proper compounding of the drug product?
7. Testing and Quality Assurance: Is sophisticated, difficult to perform testing of the compounded drug product required to ensure potency, purity, performance characteristics, or other important characteristics prior to dispensing? Is there a significant potential for error in the testing of the drug product that could affect safety or effectiveness?

The response and results will be presented next week.


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

FDA Testing Generic Drugs
The FDA is increasing scrutiny of generic drugs made in India, and in the past nine months banned imports from four plants belonging to Ranbaxy Laboratories Ltd. and Wockhardt Ltd. Generic drugs make up almost 80% of U.S. prescriptions and now are being tested in FDA's first widespread safety and quality evaluation effort costing $20 million.
http://www.bloomberg.com/news/2014-02-21/first-u-s-testing-of-generic-drugs-is-unveiled-by-fda.html

OTC Drugs to be Better Scrutinized
The FDA is proposing significant changes on how it regulates over-the-counter (OTC) drugs to make it easier to react to new information on a product's safety or recommended use. The current rules for OTCs are more than 40 years old, and do not require manufacturers to get approval as long as the main ingredient had previously been deemed safe and effective for that entire category of medications.
http://www.reuters.com/article/2014/02/21/us-usa-drugs-otc-idUSBREA1K1EW20140221

'Pay-to-play' Allegations on FDA Painkiller Approval Being Probed by Senators
Sens. Joe Manchin (D-W.V.) and David Vitter (R-La.) are probing allegations that pharmaceutical industry members paid large sums of money to meet with members of the FDA; this occurred prior to the agency's approval of a controversial painkiller. Reports surfaced that the Dean of the School of Medicine and Dentistry at the University of Rochester arranged for members of the pharmaceutical industry to sit with FDA officials at conferences at a cost of between $25,000 and $35,000 each. "The FDA's approval process should not compromise patient safety for financial gain," the senators wrote.
http://thehill.com/blogs/healthwatch/food-safety/199338-senators-probe-pay-to-play-allegations-on-fda-approval-of

Clinical Trials Dropping India
Clinical trials in India have dropped by more than 60% since 2010. Clinical research organizations (CROs) and drug research companies are bypassing India and exploring alternative locations for drug studies.
http://www.livemint.com/Industry/bQu4EtyMUgkAXEuDade3YN/Uncertainty-on-approvals-sees-exodus-of-clinical-trials.html

FDA Petitioned for a Black Box Warning on Testosterone Products
Public Citizen petitioned the FDA to immediately add a black box warning about the increased risks of heart attacks and other cardiovascular dangers to the product labels of all testosterone-containing drugs available in the U.S. They state there is growing evidence of the risks of heart attacks and other cardiovascular dangers from many individual randomized studies going back as far as 2010 and a recently published overall analysis (meta-analysis) of 27 studies going back as far as 20 years. Although 13 of these studies, funded by the drug industry, collectively showed no increased risk, the 14 studies not funded by the industry collectively showed a highly significant increased cardiovascular risk. The petition is available at:
http://www.citizen.org/hrg2184.

http://www.fiercepharma.com/press-releases/public-citizen-petitions-fda-black-box-warning-testosterone-products

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A couple of minutes each day on the computer during off-time will result in learning something new every day. It's better than spending time on something new like candy crush, funny birds, etc�and, it may help if you ever get to appear on Jeopardy!

Said one whisker
To another,
Can't get tough
With this stuff, brother!
     Burma Shave

PCAB is proud to announce the accreditation of the following pharmacies:

Corona Specialty Pharmacy, Corona, California; Diane Ahn, PharmD; mdmxinc@gmail.com. Re-Accreditation for Nonsterile Compounding

Clearspring Pharmacy Ltd., Highlands Ranch, Colorado; Rachel Burns, PharmD, highlands@clearspringrx.com. Initial Accreditation for Sterile & Nonsterile Compounding

Northmark Pharmacy, Blue Ash, Ohio; Deepali Chachare, RPh, dchachare@cincinnatieye.com. Initial Accreditation for Sterile Compounding

Medimix Specialty Pharmacy, Jacksonville, Florida; Lisa Horkan, PharmD, lhorkan@medimixpharmacy.net. Initial Accreditation for Nonsterile Compounding