Editorial: AMA Action on Non-FDA-Approved Compounded Medications

In the summer of 2006, the AMA House of Delegates approved H-120.945 AMA Action on Non-FDA-Approved Compounded Medications, which seems clearly and strongly to endorse USP compounding chapters and monographs and the Pharmacy Compounding Accreditation Board activities. The full text is copied below for your information, followed by the web link.

"Our AMA:

1. recognizes that compounding pharmacies must comply with current United States Pharmacopeia and National Formulary (USP-NF) compounding monographs, when available, and recommends that they be required to conform with USP-NF General Chapters on pharmaceutical compounding to ensure the uniformity, quality, and safety of compounded medications;

2. recognizes the accreditation program of the Pharmacy Compounding Accreditation Board (PCAB^TM) and the PCAB Seal of Accreditation as a means to identify compounding pharmacies that adhere to quality and practice standards, including those set forth in the USP-NF, for the preparation of individualized medications for specific patients;

3. encourages all state boards of pharmacy to require compounding pharmacies in their states to obtain the PCAB Seal of Accreditation or, alternatively, to satisfy comparable standards that have been promulgated by the state in its laws and regulations governing pharmacy practice; and

4. encourages state boards of pharmacy and the National Association of Boards of Pharmacy (NABP), the umbrella organization for state boards of pharmacy, to work with the U.S. Food and Drug Administration (FDA) to identify and take appropriate enforcement action against entities that are illegally manufacturing medications under the guise of pharmacy compounding. (BOT Action in response to referred for decision Res. 521, A-06)."

http://www0.ama-assn.org/apps/pf_new/pf_online?f_n=resultLink&doc=policyfiles/HnE/H-120.945.HTM


Loyd V. Allen, Jr., PhD, RPh

Counties in California are Allowed to Sue Drug Makers
A federal appeals court approved the reinstatement of Santa Clara County's lawsuit against pharmaceutical companies for allegedly overcharging county hospitals for prescription drugs for Medi-Cal patients, in violation of a federal law requiring discounts.

The ruling by the Ninth U.S. Circuit Court of Appeals in San Francisco is the first in the nation stating that counties have the right to sue manufacturers under the drug law. The 1992 law requires companies supplying medicines to the Medicaid program (Medi-Cal in California) to sell them to public hospitals at a specified percentage of their average nationwide price.
http://www.therapeuticsdaily.com/news/article.cfm?contentValue=1829413&contentType=sentryarticle&channelID=33

Stanford to Limit Drug Maker Financing
Stanford University is concerned about the influence drug companies have on medical education and is expected to announce that it will severely restrict industry financing of doctors' continuing education at its medical school. Nearly all physicians in the country must take continuing education courses that drug makers have long paid for. While the industry says its money is intended solely to keep doctors up to date, critics charge that companies agree to support only classes that promote their products.
http://www.therapeuticsdaily.com/news/article.cfm?contentValue=1828797&contentType=sentryarticle&channelID=33

Experts Agree: Fixing Health Care Will Be Expensive
Sixteen healthcare experts from around the country shared their thoughts about how the next president could reform the healthcare system in the U.S. Their meeting was moderated by former Senate Minority Leader Tom Daschle. The panel concluded that fixing the system would involve a greater focus on nutrition and exercise, preventative care, providing coverage for the country's 47 million uninsured, upgrading the sector's information technology, and getting more federal dollars for research for new drugs.

The panelists concurred that reforming the system is an expensive proposition and discussed the reason we have such a dysfunctional system is because so many people are making a lot of money taking advantage of the current system.
http://www.bizjournals.com/denver/stories/2008/08/25/daily12.html

Drug Makers Battle for the Right to Track Prescriptions
When most patients go to the pharmacy to get a new prescription filled, they don't think twice about turning over the piece of paper from their doctor. After all, how much could the scrawled handwriting on that tiny slip be worth?

Not much to the average consumer-but to the world's largest drug makers, the information is an invaluable sales tool they use to track what drugs individual doctors are prescribing all across the country.

Companies such as IMS Health have built an industry around gathering prescription data and selling the information to pharmaceutical companies for millions of dollars each year.
http://www.therapeuticsdaily.com/news/article.cfm?contentValue=1826973&contentType=sentryarticle&channelID=33

...that the prices of bulk powder hormones may begin to rise due to the Chinese government shutting down factories for the Olympics and that many of the factories are not going to be allowed to restart. Editors Note: When will we learn that if it's not done in the U.S., we have little or no control availability!

Ten more SOPs added to CompoundingToday.com website this week. They can be reviewed and downloaded at CompoundingToday.com's SOP Page.

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