Editorial: USP Chapter <797> Frequently Asked Questions

USP Pharmaceutical Compounding-Sterile Preparations will become official on June 1, 2008. With so many questions coming in on various aspects of <797>, we will take a few issues of this Newsletter to address some of the most commonly asked questions.

Question: I work in a small hospital and we need to meet USP <797> standards. Can we just handle all our sterile compounding as "Immediate-Use" compounding?

Answer: Although this may seem like a good idea, actually it is not. The Immediate Use section of <797> is intended for emergency purposes or when immediate patient administration of a compounded sterile preparation (CSP) is required; this provision is not intended for anticipated needs or where storage might be involved. Immediate-Use CSPs include only "low-risk" preparations and not medium-risk or high-risk preparations. There are six criteria that must be met for this provision and include the following considerations (Note: See chapter for all the details.):

1. Simple transfer of not more than three commercially ingredients of sterile nonhazardous products or diagnostic radiopharmaceuticals from manufacturers' original containers and not more than two entries into any one container.
2. The process is continuous and does not exceed 1 hour.
3. Aseptic technique is followed and if not immediately used, is under continuous supervision to minimize potential for contamination.
4. Administration begins not later than 1 hour following the start of preparation of a CSP.
5. Unless immediately and completely administered by preparer or observed by preparer, the CSP will be appropriately labeled.
6. If administration is not begun within 1 hour after the start of the preparation, the CSP is promptly, properly, and safely discarded.

As evident, there are limitations in this new addition to <797> and, therefore, it is not reasonable to use it in a small hospital with full pharmacy services. One primary reason is that nothing can be prepared ahead of time. Only low-risk preparations can be compounded; medium-risk and high-risk preparations cannot be compounded. The short one-hour time period from the "start of compounding until administration begins," will be impractical for most hospitals. Immediate-use compounding does not allow for storage of the finished compounded preparation.

Next week's Newsletter will discuss low-risk with 12-hour or less beyond-use date.


Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief

Costs Soar for Massachusetts Universal Health Care Law
Regarding the Massachusetts Universal Health Care Law we have heard so much about, Michael Tanner, a senior fellow at the Cato Institute, said the law has been an unqualified failure. "They said it would get us universal coverage and reduce costs and it's done neither," Tanner said. The biggest challenge—rising costs.

In 2006, a Massachusetts legislative committee estimated the law would cost about $725 million in the fiscal year starting in July. In his budget, Governor Patrick set aside $869 million, but those overseeing the law have already acknowledged costs will rise even higher. Lawmakers are hoping to close the gap in part with a new cigarette tax expected to generate about $154 million a year. For more information: http://ncpa.yellowbrix.com/pages/ncpa/Story.nsp?story_id=116344941&ID=ncpa

Direct Marketing to produce $10.6 Billion in 2008 Pharmaceutical Sales
This year, pharmaceutical companies are forecast to generate $10.6 billion in sales through direct marketing, and that figure is expected to hit $15.2 billion in 2012. These are key findings in a new Direct Marketing Association (DMA) report entitled "Direct Marketing Facts and Figures in the Pharmaceutical Industry." See the story at: http://pharmalive.com/news/index.cfm?articleID=530270&categoryid=9&newsletter=1

Senior Massachusetts Democrat says the opportunity inherent in personalized medicine is "unlimited."
Editors Note: "They have stolen our phrase!" It appears that now even Ted Kennedy is talking about personalized medicine: AZ CEO uses the phrase "customized medicine," but I don't think they are on the same page as compounding pharmacists.

"A new era of personalized medicine" is coming, Kennedy said at a breakfast meeting. "And those are words we're going to hear a great deal more about."

He added: "The opportunity is unlimited." AZ CEO David Brennan later echoed Kennedy, "the point Senator Kennedy made about personalized medicine is an important one."

If the senior Senator from Massachusetts is aligned with the pharmaceutical industry on the future of medicine, ladies and gentlemen, break out your checkbooks, call your broker and start buying up biopharma concerns.

Kennedy's comments were brief, so I don't want to give the impression that his talk was a treatise on customized medicine [emphasis added]. However, he made it a point to highlight the approach, along with prevention and disease management, as one road that should be well-traveled as the nation seeks solutions to the "healthcare crisis." Please read more about this at: http://therpmreport.com/Free/3f8905c6-1210-4901-ac87-8da02ec986d2.aspx?utm_source=SmartBrief

IJPC supplies this list of providers of USP Chapter <797> products as a service to our readers. Thus far, our newsletters have featured the following products:

Next week's newsletter will feature sterility testing kits. We strongly urge you to support IJPC's current advertisers and supporters listed in bold.

Managed care and third-party companies contribute very little, if anything, to actual healthcare delivery, but control the financing and rake off large sums and profits? What happened to the days when the physicians, pharmacists, other healthcare professionals, and patients worked together to provide affordable healthcare without these "carpetbaggers"?

Spring Cleaning
Don't forget to have an air conditioner service company clean or change your air filters in your store and flush out all the debris in your compressors; it will save a lot of money this summer. The same goes for your home.