...It is an incredible tool for literature searches, especially if you work in an institutional setting and do not have access to tech services. It will give you all of the IJPC articles and references plus other medical/professional journal citations. This is primarily how I am getting all of my info now. It is saving me hours of going onto OVID or PubMed looking for compounding info or clinical evidence.

There are a lot of great compounding tools on CT.com, like endotoxin levels, pre-written SOPs, and hundreds of formulas. For the price, it is the best compounding reference available.

Linda F. McElhiney, PharmD, RPh
Compounding Pharmacist
Clarian Health Partners, Inc.
Indianapolis, IN

Last week we introduced "Specials"; many readers were not aware of what they are. In essence, "Specials" would be similar to what occurred here in the U.S. many, many years ago when one pharmacy started compounding large batches of a preparation and made it available to other pharmacies for dispensing; this was the beginning of the pharmaceutical manufacturing industry.

Is there any justification for these "Specials"? I can think of two definite needs right now. First, there are thousands of "discontinued drugs" that were discontinued for economic reasons; the manufacturer was not making enough money so they dropped the product. Other discontinued drugs occur when companies merge and they look at the combined product lines and drop those that do not generate sufficient income to meet their goals. Second, there are the compounded formulations that are very, very commonly made. If these were available to those pharmacies that did no compounding, the patient, dispensing pharmacist and "Specials" compounder would all benefit. One advantage of "Specials" is there is the general increase in quality and uniformity that occurs when large batches are made with appropriate quality control testing, procedures, etc.

Is there a downside? There is always a downside to almost every subject. The downside here may be that some compounders fear a loss of some business. That shouldn't be the case as "Specials" could supplement, not replace, current compounding practice. If Drug X was available as a 60 mg capsule as a "Special" but you wished to continue to compound it, that would be okay ...it would be your choice. Compounding pharmacies could select some of these "Specials" for dispensing to free up their personnel to compound other preparations and they can expand into other types of compounding without the requirement of building a larger facility, etc.

What might be the requirements for these "Specials" compounding pharmacies? Basically, they would need to follow Good Manufacturing Practices as well as Good Compounding Practices to document proper quality control in the type of compounding done, nonsterile and/or sterile. They could be limited to standardized formulas with valid beyond-use dates. They would need to be licensed with the individual state boards of pharmacy in the states they serve. In the UK, they are licensed with the UK Medicines and Healthcare products Regulatory Agency. If registered (not licensed) with our Food and Drug Administration, it could be the facility and not the products. In other words, the facility, equipment, standard operating procedures, etc. could be required to meet certain standards, as they do in the UK.

What would these Specials compounding facilities be exempt from? Basically, they would not be required to file an NDA, ANDA, etc. with the FDA for each preparation that is compounded. The drugs allowed to be compounded by these "Specials" compounding pharmacies would be those with good safety profiles and in general use throughout the U.S. and/or world.

We may already have the beginning of this type of compounding in the U.S. in a limited way. For example, some of the large chains have a specific store designated to do the compounding for other stores; technically, this is a similar situation. Some hospitals have arrangements with other pharmacies or combination compounder/manufacturer to do sterile preparations compounding; this also is a similar situation. Clinical studies are similar when they involve multiple sites: the dosage forms are prepared and distributed to the research pharmacist at the specific sites for the respective studies.

What is the likelihood of all this happening? Actually, it's probably not very likely in the near future but may be down the road. As the pharmaceutical industry continues to limit dosage forms that are available and as more drug products are discontinued, many of these could be picked up by these "Tweeners" or "Specials" compounding/manufacturing pharmacies.

For more information, see future issues of IJPC at http://www.IJPC.com and a current feature at: http://www.pjonline.com/pdf/features/pj_20051217_specials.pdf

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

Now you can get all the Tonicity adjustment information you need for the five excipients list in the USP 29-NF 24 classified as "tonicity" agents, including:

• dextrose
• glycerin mannitol
• potassium chloride
• chloride plus
• sodium chloride

Go to http://www.CompoundingToday.com/TonicityAdjust

Look no further than the International Journal of Pharmaceutical Compounding's (IJPC) Compounders Network List. It's free and it's easy to sign up. Sign up from either of IJPC's websites www.IJPC.com or www.CompoundingToday.com.

This week on the network pharmacists discussed:

• Ear drop formulations for dogs.
• Sublingual hormone delivery.
• Sterilized pluronic gel as a delivery agent for the treatment of abscesses with antibiotics.
• How to handle physician referrals
• Nipple tenderness in a patient on progesterone.
• The ingredients on a product called either "Octin" or "Oc-vet"
• Methimazole in PLO dosing in cats.

This week more than 50 articles were added to CompoundingToday.com's literature search service. The citations as well as the abstracts can be found at www.CompoundingToday.com/articles/. Articles added this week are all related to cancer care. Here is a sampling:

• Gairard-Dory AC, Schaller C, Mennecier B et al. Chemoradiotherapy-induced esophagitis pain relieved by topical morphine: Three cases. J Pain Symptom Manage 2005; 30(2): 107-109.
• Lo B, Rubenfeld G. Palliative sedation in dying patients: "We turn to it when everything else hasn't worked." JAMA 2005; 294(14): 1810-1816.
• Mercadante S, Ferrera P, Villari P et al. Aggressive pharmacological treatment for reversing malignant bowel obstruction. J Pain Symptom Manage 2004; 28(4): 412-416.
• Rao A, Cohen HJ. Symptom management in the elderly cancer patient: Fatigue, pain, and depression. J Natl Cancer Inst Monogr 2004; 32: 150-157.
• Von Roenn JH, Paice JA. Control of common, non-pain cancer symptoms. Semin Oncol 2005; 32(2): 200-210.

When: April 1 & 2, 2006
Where: PHF Conference Center, 655 Research Parkway, Oklahoma City, Oklahoma 73104
Featured Speakers: Thomas Kupiec, PhD., Loyd V. Allen, Jr., PhD., RPh. and Kenneth R. Baker, RPh., JD

Click Here for more Information: www.spectrumrx.com/SpectrumRx/events/QAseminar.asp

Office Use Only Labelling
In compounding for Office Use Only, in addition to the standard state board of pharmacy requirements for the label, be sure the Beyond-Use Date is clear and be sure that the words "FOR OFFICE USE ONLY" and "NOT TO BE DISPENSED OR SOLD TO A PATIENT" are clearly placed on the label.