Let me begin by stating that the USP Compounding Pharmacy Expert Committee has a very difficult job to do. And, it must be done appropriately, both scientifically and realistically for patient access to CSPs. I don't believe we are there yet with this proposed revision.

The maximum beyond-use date (BUD) is proposed to be 42 days with no extensions. From where does the 42 days come? It comes from the 14 days to conduct a USP <71> test and the 28 days to conduct a USP <51> test; 14 + 28 = 42 days. The "time to conduct tests" is no basis for a BUD.

Last week's editorial on the proposed USP <797> changes generated numerous interesting responses related to the BUDs. One pharmacist provided the following three articles related to the viability of microorganisms in IV drug solutions, as follows:

1. Favier B, Latour J, Fuhrmann, C. Viability of microorganisms in bags of cytotoxic drugs. J Oncol Pharm Practice 2001; 6(4): 167-171.

2. Karstens A, Kramer I. Viability of micro-organisms in novel anticancer drug solutions. European Association of Hospital Pharmacists 2007; 2: 27-32.

3. Kramer I. Viability of microorganisms in novel antineoplastic and antiviral drug solutions. J Oncol Pharm Practice 1998; 4(1): 32-37.

In the Favier et al article, their results showed "No microbial growth was found; on the contrary, bacterial and fungal growth decreased rapidly and substantially with cisplatin and doxorubicin (by 2 log after 24 hours), moderately with 5-fluorouracil, and weakly or not at all with cyclophosphamide."

The other two articles were somewhat different and were designed to evaluate the growth of different microorganisms in diluted solutions of drugs. Most of the drugs did not show any antimicrobial activity themselves. Included in their conclusions was: "�micro-organisms can survive in diluted solutions of antineoplastic drugs and proliferate when transferred to proper growth media. Solutions containing the studied drugs showed neither growth-retarding nor growth-supporting properties."

The tables presented in the studies showed that the microorganisms did not proliferate rampantly (as some have suggested), and some decreased in numbers. They will grow, however, when placed into a nutrient-containing environment.

This raises the question, should a "one-size-fits-all" approach to BUDs and lumping all drugs into the same system based on the preparation location need to be evaluated further. Some drugs (e.g., antibiotics, and drugs present in higher concentrations exhibiting antibacterial properties and those in nonaqueous vehicles) may be suitable for much longer BUDs.

�just thinking and questioning�patient access depends upon it!

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

News

The following short reports are presented to introduce the topic for next week's Newsletter regarding FDA's position to not accept USP monographed dietary supplements for compounding.

FDA Continues Work in Identifying Substances Appropriate for Compounding
[August 1, 2015; AJHP News]

Even though there is a USP dietary supplement monograph for N-acetyl-D-glucosamine, the substance does not automatically qualify for use in compounding drug products, The FDA's lead on compounding issues revealed during a recent Pharmacy Compounding Advisory Committee (PCAC) meeting.

"We don't consider dietary supplement monographs to be the kind of monographs that they [legislators] were referencing in the statute as being OK to compound," Jane Axelrad said. "It has to be on this list."

The list, which does not yet officially have any entries, names bulk drug substances that pharmacists and physicians may use to compound prescription drug products despite those substances lacking an "applicable" USP or National Formulary monograph and not being a component of any FDA-approved drug product.

"It's a cumbersome process," Axelrad said of placing a substance on the list.
http://www.ashp.org/menu/News/PharmacyNews/NewsArticle.aspx?Source=News&Type=Rss&Id=4227

FDA Attack on Supplements
The FDA's hostility toward both supplements and compounded medicine is legendary-after all, they compete with the FDA-approved drugs that pay the government's bills. Now the agency is attacking compounded supplements.

The House Appropriations Committee recently scolded the FDA for implementing the law "in a manner inconsistent with its legislative intent." This isn't the first time that members of Congress have made it clear that the FDA is going too far in its compounding regulations.

Despite these warnings, the FDA continues its attack on compounding. Where in the legislation does it say that the FDA can ban compounded supplements?
http://www.anh-usa.org/fda-compounds-its-attack-on-supplements/

FDA Overstepping its Authority--Again
At a recent PCAC meeting, an FDA representative said that nutritional supplements will need to be on a pre-approved list in order to be compounded. However, nowhere in the legislation does it say that the FDA can ban compounded supplements.
http://www.anh-usa.org/action-alert-fda-attack-on-compounded-supplements/

IJPC Now on Facebook and Youtube

Become a fan of the IJPC Facebook page and share ideas, photos, and keep up to date with the latest compounding information - http://www.facebook.com/IJPCompounding

Learn about the Journal's new multi-media features and view our growing collection of educational and training videos at www.ijpc.com/video or by subscribing to our Youtube channel at https://www.youtube.com/user/IJPCompounding.

Did You Know ...

�that the "Universe" is not represented?

Tip of the Week

The "universe of pharmacists" that is�.The PCAC minutes are available for all to read. Regarding drugs that are requested to be put on the list, the question is often asked by the FDA, "Does anyone know if this is compounded?"

Obviously, if someone has taken the time to put together the information required to submit to the FDA for consideration for the list, it is compounded. However, another larger question arises and that is the composition of the committee. How many compounding pharmacists are on the committee? Every compounding pharmacy practice is different, depending upon the physicians and patients they serve. The committee contains physicians, academicians, other healthcare practitioners, and a few (very few) compounding pharmacists. Consequently, pharmacists are not very well numerically represented (especially those involved in compounding). BUT, these non-compounders may vote on whether or not to allow a drug to be compounded not knowing how many patients are depending upon it. True, if an "observer" is present, they may be allowed to respond, if they will. But too many patients health is dependent on the very limited real knowledge-base of the PCAC. However, they make the decisions for all!

Looking Back

Why is it that
When you pass,
The guy in front,
Goes twice as fast?
     Burma Shave