Must Read! Trends in FDA cGMP Violations: Department of Justice announced that compliance with current good manufacturing practices (cGMPs) will be one of the agency's "top areas of focus

We have previously written that one of the new trends in enforcement in the life sciences industry is the focus the federal government is having on compliance with current good manufacturing practices (cGMP).

For instance, we noted back in February of this year that the U.S. Department of Justice announced that compliance with current good manufacturing practices (cGMPs) will be one of the agency's "top areas of focus" in the coming year." Additionally, we recently noted that DOJ has been probing international pharmaceutical manufacturing, investigating several companies and their manufacturing practices over the last several months.

Most recently, DOJ filed a lawsuit on behalf of the FDA against Mitchell, SD-based Dakota Laboratories and its owner Charles Voellinger, as reported by FiercePharmaManufacturing. The suit came after inspections in 2010, 2011 and 2012 found significant manufacturing lapses in the plant's production of eye drops, including a lacking of procedures to protect against microbiological contamination. Among other issues, a 2011 FDA warning letter said the company had released several batches of sterile ophthalmic eye drops without adequately validating aseptic processes, and wasn't testing the water used to make the drops.

- See more at: http://www.policymed.com/2013/12/trends-in-fda-cgmp-violations.html#sthash.denFL6W0.dpuf

The Discrediting OTC Ads – Articles Include Potentially Misleading Claims

A recent study published in the Journal of General Internal Medicine found that as many as "six out of 10 pharmaceutical ads" contain "potentially misleading claims." The objective of the study was to compare claims in direct-to-consumer (DTC) television advertising with the FDA approved labeling in order to evaluate the frequency of false or misleading ads.

The United States is one of the only countries in the world that allows drug companies to directly advertised to patients or consumers through basically any medium—television, magazine, newspaper, etc. However, we recently reported that advertisements online and through social media have been a difficult and uncertain area for companies to advertise due to the lack of guidance and clarity from FDA on the issue.

To conduct the study, the authors analyzed a cross-section of TV ads for prescription and nonprescription drugs aired from 2008 through 2010 on ABC, CBS, NBC and CNN broadcasts. The researchers looked only at ads between 6:30 and 7:00 pm EST.

It should be noted that advertisements of any kind for nonprescription drugs (e.g., over-the-counter) are regulated by the Federal Trade Commission (FTC) not the FDA—however, FDA and FTC have a close working agreement to determine whether a nonprescription drug ad may be making an improper claim.

- See more at: http://www.policymed.com/#sthash.xMIQLeoH.dpuf

IACP’s 20th Annual Compounders on Capitol Hill! May 17-20, 2014

for more information and to register can be found here

Transcript of IACP Questions and Answers from December 3, 2013 Meeting is now available

here

Reminder: IACP Needs Your Input: List of Drugs with APIs

As covered in our Town Hall teleconference and in the story below, several regulations and requests for input were issued by the FDA on December 4. One of the most critical is the agency's request for a list of drugs for which APIs (Active Pharmaceutical Ingredients) are necessary for compounding preparations. As provided for within 503(a), a pharmacist or physician may compound medications for individual patients using an API only if that drug has a USP monograph, is a component of an FDA approved drug, or appears on a list of APIs reviewed and approved by the FDA's Pharmacy Compounding Advisory Committee and accepted by the Secretary of Health and Human Services. 

IACP is assembling a list of APIs used regularly in compounding for which no USP monograph exists or is part of an FDA approved drug to submit on behalf of our members. We need your assistance in identifying as many of these as possible.  

Please submit the following information for each API you use that falls into this category to us at iacpinfo@iacprx.org no later than January 15, 2014:

• Name of the API including the chemical name and common name
• Chemical grade, strength, quality and purity of the API
• Form of the API (powder, liquid, etc.)
• Whether a monograph in an ex-US pharmacopeia exists such as the British Pharmacopeia
• Common compounded dosage forms, strengths and route of administration for which the API is used
• Clinical data, studies, papers, references, etc. on how the compounded version of the API is used
• Stability data for the compounded preparations

The Academy will compile a formal dossier on each of these medicines you help identify for submission to the agency in time for its March 4, 2014 comment deadline.  

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IACP announces 2014 Board of Directors

The 2014 Board of Directors are:

President
Pat Stephens, PharmD
Medi-Fare Drug & Home Health Center, South Carolina

President Elect
Dale Coker, RPh, FIACP
Cherokee Custom Script Pharmacy, Georgia

Chairman of the Board (Past President)
Wade Siefert, RPh
Preckshot Professional Pharmacy, Illinois

Vice President
Gary McCrory, RPh, CCN
McCrory's Pharmacy, Inc., Texas

Treasurer
Bill Letendre, MS Pharm, MBA, FIACP
PCCA, Texas

District I
Roses Stewart, BSP
Victoria Square Dispensary, Canada

District II
Ernest P. Gates, RPh, FASCP, FIACP
Gates Healthcare Associates, Inc., Massachusetts

Lucy Malmberg, RPh, FACA, FACVP
Wedgewood Village Pharmacy, Inc., New Jersey

District III
Baylor Rice, RPh
South River Compounding Pharmacy, Inc., Virginia

Jennifer L. Burch, PharmD, RPh, CDE, CPP
Central Compounding Center, North Carolina

District IV
Scott Wepfer, RPh, FIACP
The Compounding Shoppe, Alabama

Sam Pratt, RPh, FIACP
Pharmacy Specialists, Florida

District V
Lisa Ashworth, BS, PharmD, RPh
Children's Medical Center, Texas

1 Open Seat

District VI
David J. Miller, RPh, PhD, FIACP
Keystone Pharmacy, Michigan

Scott Popyk, RPh, FIACP
Health Dimensions, Michigan

District VII
Denise Burnham, RPh
Creative Compounds, Oregon

Kevin Borg, PharmD, FIACP
Potter's House Apothecary, Arizona

At-Large Members
Erik Tosh, RPh
Letco Medical, Texas

Diana Harshbarger, PharmD
Custom Compounding Centers of America

IACP Members: IACP is seeking volunteers to serve the open seat in District V (Louisiana, Texas, Oklahoma, New Mexico). Please send your input to IACP atiacpinfo@iacprx.org. Your commitment and dedication to the Academy is much appreciated.

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Critics: State Inspectors at Root of Pharmacy Errors

By FRED HIERS
HALIFAX MEDIA SERVICES

Published: Friday, December 27, 2013 at 8:36 p.m.

Last Modified: Friday, December 27, 2013 at 8:36 p.m.

Second of four parts.

The deaths of 64 people injected with contaminated drugs created by New England Compounding Center last year drew wide public attention because of the scale of the tragedy and the mistakes uncovered after the fact, but the incident was by no means isolated.

In 2007, three people died after being injected with a compounded drug made in a Texas pharmacy. Inspectors discovered that drugs' were six times as potent as the labels indicated. Tougher state oversight would have prevented the deaths, critics say.

continue to read here

Must Read National Uniform Medication Program-Racing Reform--With Charts of States that Have Passed the New Rules

found here

Ethics: End of the hard sell? Pharmaceutical groups are finding their marketing and sales tactics under increasing scrutiny DECEMBER 27, 2013

By Andrew Jack
read here

Missouri Veterinary Medical Association Convention Friday, January 31, 2014 - Sunday, February 02, 2014

more information here