The question that is frequently asked at various seminars and via telephone is, "How much testing should I do?" This is a very difficult question to answer. As pharmacists, we are accustomed to following detailed procedures and when the response to this type question is "it's up to you," a feeling of helplessness or frustration often sets in. Actually, when reviewing the standards for either the pharmaceutical industry or pharmacy compounding, they are not prescriptive in nature. Standards are set, but there are many ways of meeting them.

What would happen if a standard was set and there was only one way provided in the standard to meet it? Obviously, everyone would be doing the same thing. But, the required method of achieving the standard may mean that there is no other allowable way of achieving it. As new technology comes along and as new methods of accomplishing the standard were adopted, we would still be stuck in the old way of doing things.

Consequently, one has many different options available to meet the standards. If I want to travel from Edmond, Oklahoma to Washington, DC, I can fly, drive, ride a bus or train, ride a bike, or even walk; each choice has different options regarding the routes that might be taken. In other words, I have a lot of options.

Meeting United States Pharmacopeial standards provides the pharmaceutical industry and compounding pharmacists many options in meeting these standards. It is true, then, that we have to think more rather than just react; research the options rather than just routinely follow the only directions given; and make decisions about the options available.

In response to the question presented above, "How much testing should I do?," the answer is obviously left up to you. We know that if 1,000 preparations are compounded each week and only one is tested, that is insufficient. However, if you only do five a week, one may be excessive. Somewhere in between lies the answer. Obviously the cost of testing, difficulty of testing depending upon the matrix involved, nonsterile vs. sterile preparations, etc., all enter into the equation. This is why it is important to look at the tests that are available, their costs, and what information you need to verify that your compounded preparations are meeting the United States Pharmacopeia Chapter <795> standards. Verification of processes is important along with final preparation testing. A combination of in-house and outsourced testing can easily help address the costs involved and help in meeting the standards. It is often beneficial to ask what others are doing as we slowly build up more experience in verifying quality assurance processes in compounding preparations.


Loyd V. Allen, Jr., Ph.D., R.Ph
Editor-in-Chief

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DOGcaps� & CATcaps� - flavored, empty gel-capsules for pets by Capsuline�
Pompano Beach, FL -- September 27, 2006

DOGcaps� & CATcaps� are innovative products for pet-lovers and veterinarians alike, and is the perfect solution to the difficult task of pilling cats and dogs. Whether for pharmaceutical, holistic, vitamin, or herbal use, these vet-recommended gel-caps mask unpleasant odors and tastes, making them a flavorful alternative that eliminates the need to force-feed, use pill dispensers, or resort to hiding the remedy in unhealthy foods or treats.

Capsuline� has a patented process for creating empty, flavored gelatin capsules for consumption by children, adults, and, most recently, dogs and cats. "If you listen to your customers, sometimes they tell you exactly what they want, and that's how DOGcaps� & CATCaps� were created," says Capsuline� CEO Jonathan Gilinski. "In testimonial after testimonial, we started to notice that the intended end-user of our product was a pet, so we developed a product line that appealed specifically to the palates of our four-legged friends."

In an independent palatability study commissioned by Capsuline�, of the dogs and cats studied, 95% of them readily accepted the capsules with no coercion.

DOGcaps� come in two sizes "0" and "1" and three flavors - chicken, beef, or bacon and the smaller CATcaps� size "3" comes in beef and chicken flavor with new sizes and flavors in development. The pharmaceutical-grade gelatin capsules are easy-to-fill, safety tested, fast-dissolving, and, in addition to monthly pet medications, they're perfect for the rapidly growing supplement and holistic pet product category. Both DOGcaps� & CATcaps� are sold in retail packs of 25 and 100 or in bulk packaging starting at 1,000 count.

Visit them online for more information, testimonials, and free samples at: DOGandCATcaps.com or contact: Bianca Montalvo, Director of Customer Relations Capsuline, Inc., P.O. Box 667260, Pompano Beach, FL 33066, Phone: 954-975-6623, BMONTALVO@Capsuline.com

A compounding pharmacist can play a vital role in preparing topical cidofovir cream or gel to assist the prescribing physician and the patient in the treatment of resistant viral infections. See the article titled "Topical Cidofovir for Treatment of Resistant Viral Infections" about this subject on pages 324 through 328 of IJPC's September/October 2006 issue. If you are not a subscriber you can purchase and download the article at www.ijpc.com/backissues/ArticleDescription.cfm?ABS=2441

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Trouble with Odors?
Need to get rid of odors in a room or in a facility? Try burning one or more nonscented candles, carefully observing normal precautions