Editorial: It's Here—USP Chapter <797> is Official

After several years of very demanding committee work, USP Chapter <797> is finally official! What does this really mean? Basically, it means we have official standards for compounding sterile preparations in the U.S. They are official because the U.S. Congress has named the United States Pharmacopeia as one of the official compendia of the U.S. What is an "official compendia"? It is a collection of monographs, general chapters, etc. related to pharmaceuticals and pharmacy practice that provide standards that must be met.

As the United States Pharmacopeial (USP) has no enforcement authority, it depends upon the U.S. Food and Drug Administration to enforce standards related to the manufacturing of pharmaceutical products; it depends upon the individual state boards of pharmacy to adopt or incorporate (partially or completely) the standards for the compounding of pharmaceutical preparations; there are also standards for the dispensing functions of pharmacy practice.

Over the past six months, some have said the new standards are too rigid; others have said they could have been stricter. All in all, the standards seem to be pretty much in line for the technology available at this point in time to ensure patient safety regarding the compounding of sterile pharmaceuticals.

Will there be any more major changes in USP <797> soon? Probably not during this USP cycle unless something drastic happens. The USP Expert Committees are elected to serve five-year terms at the USP Conventions. The next convention will be held in 2010. While there may be some minor changes, clarifications, adjustments, etc., there will probably not be any additional major changes this cycle.

The <797> workshops conducted by the USP were very successful, with the last workshop having about three times the number of participants as the first. They were very well-presented workshops and worth the time and expenditure to participate.

While many are still working towards becoming compliant with USP <797>, it appears that the majority of facilities plan to be compliant within one year.


Loyd V. Allen, Jr., PhD, RPh

Compounding on Capitol Hill
This year's Compounding on Capitol Hill event, sponsored by the International Academy of Compounding Pharmacy, was another smash hit. With great educational programming, superb banquets/meals, and the incredible visits to the "Hill," it was a meeting to attend!

Drug Deaths in China
The state media in China reported that authorities have suspended the sale and use of a brand of antibody drugs after six people died following injections.

The Xinhua news agency said late on Sunday that the unidentified victims died in east China's Jiangxi province after being given human immunoglobulin at a hospital in the provincial capital Nanchang between May 22 and 28. It was unclear why the infection-fighting proteins, made by Jiangxi Yabo Bio-Pharmaceutical Co (JYBC), caused the deaths after injections made at the Second Affiliated Hospital of Nanchang University.

Human immunoglobulin, a protein produced by the body, is used in the treatment of autoimmune diseases when the body turns on itself and attacks its own cells.

The State Food and Drug Administration-China's drug watchdog-and the health ministry have suspended the JYBC drugs as an investigation gets under way, Xinhua reported.

China has a poor safety record when it comes to making and selling drugs. The most recent scandal concerned a blood thinner called Heparin.
http://news.yahoo.com/s/afp/20080602/hl_afp/chinadrugshealth_080602051712

Drug Not Allowed to be Compounded Under FDAMA97 Reports Positive Results in Multiple Sclerosis Patients
Editors Note: 4-aminopyridine was one of the drugs that was not allowed to be placed on the "bulk drugs list" for compounding. The reason was that Acorda complained that if it was allowed to be prescribed by physicians for MS patients, that they would not be able to get enough patients for their clinical trials. Almost ten years later and after thousands of patients have been without its benefit, the drug is just now ready for submission as an NDA.

Acorda Therapeutics announced positive results from its second Phase 3 clinical trial of 4-aminopyridine, or Fampridine-SR, on walking ability in people with multiple sclerosis (MS). A significantly greater proportion of people taking Fampridine-SR in the trial had a consistent improvement in walking speed compared to people taking placebo (42.9% vs. 9.3%), as measured by the Timed 25-Foot Walk (p less than 0.001). We have now completed two successful Phase 3 trials demonstrating improved walking ability in people with MS," said Ron Cohen, MD, President and CEO of Acorda Therapeutics. Per Dr. Cohen:

"We believe that, subject to FDA review, the results of our two Phase 3 trials are adequate to support an NDA. We expect to submit this application in the first quarter of 2009 and plan to request priority review. The results of this study indicate that Fampridine-SR could represent an important new way to treat people with MS. As of June 2, 2008, the total exposure in our MS studies to Fampridine-SR at 10 mg twice a day, including both double-blind and open-label studies, is approximately 1,100 patient years. The incidence of seizures in these studies at the 10-mg dose has been within the rates reported for placebo-treated groups in long-term controlled studies of immunomodulator drugs in MS patients. These rates have ranged up to two percent of patients in a two-year study, or one seizure per 100 patient years. The overall incidence of seizure appears to be dose-related."

Fampridine-SR is a sustained-release tablet formulation of the investigational drug fampridine (4-aminopyridine or 4-AP). In laboratory studies, fampridine has been found to improve impulse conduction in nerve fibers in which the insulating layer, called myelin, has been damaged. Fampridine-SR is being developed by Acorda Therapeutics and manufactured by Elan Corporation.
http://phx.corporate-ir.net/phoenix.zhtml?c=194451&p=irol-newsArticle&ID=1160986

Syringes are designed to measure an "approximate" quantity of a medication for injection. However, it is common practice to use them in an intravenous admixture program for measuring volumes of additives for an admixture. These syringes may not always be accurate. Therefore, when receiving a new lot of syringes, it is good practice to check the volume of the syringe for accuracy. This can be done by taring the syringe on a balance, filling the syringe with purified water, and weighing the syringe to determine the weight of water in the syringe. Since the specific gravity of water is very close to 1, it is easy to convert grams to milliliters. As an example, a 3-mL syringe should hold 3 g of water.

Hydrogen peroxide 3% solution can be used to "whiten" some stains on various surfaces, especially on concrete and tile. It is safe and easy to use. It does not work on all stains, but is effective on many.

This is the final entry of this resource directory. IJPC has supplied this list of providers of products required to remain USP Chapter <797> compliant as a service our readers. We strongly urge you to support our current advertisers and supporters. To date, our newsletters have featured the following products:

Speedy Computers
To keep your computer running smooth and fast, perform routine disk cleanup, defragmentation, virus scans, ad scans, and others. Before loading a virus and comprehensive protection program, read any evaluations that have been published about the software. Some of the programs will significantly slow down the operating speed of the computer.