This is a question I receive a lot! I think a lot of patients must "Google" compounding and the IJPC websites come up—then the question follows. Also, a lot of physicians, veterinarians, dentists, etc. have also asked the same question. How do you respond to a query like that?

Initially, that was a difficult question. However, upon thinking about it, I considered the following:

1. Is the pharmacy PCAB accredited?
2. Is the pharmacy USP compliant?
3. What does the facility "look" like?
4. Do they have "state of the art" equipment?
5. Do they have a cleanroom and clean air equipment for sterile compounding?
6. Is the pharmacist available for consultation?
7. Does the pharmacy routinely test their compounded preparations?
8. Does the pharmacy have a copy of the USP in the pharmacy?
9. Does the pharmacy have Standard Operating Procedures?
10. Can I observe the compounding personnel as they work?
11. Do the personnel appear competent from observation and questions asked?
12. What resources (print and electronic) do they have available?
13. Are all the compounding chemicals in-date?
14. Is the pharmacy "clean" and "well-organized"?
15. Does the pharmacy have any unresolved complaints filed with the state board of pharmacy?

I'm sure that many readers can add to the list above. However, this list provides a reasonably good starting point. We are all under the "magnifying glass" in all that we do. A self-assessment is the first step in making sure that you are a "good compounding pharmacy."


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

If you have downloaded Standard Operating Procedures from the www.CompoundingToday.com website please review your files and change the number and title of SOP 2.005 from Pharmacists Training and Documentation to 1.054 Recall Procedure for Sterile and Nonsterile Compounded Preparations. Also, please delete 2.005 from the list of PCAB SOP's that match up with IJPC. 1.054 was already on the PCAB list but was an incomplete SOP. A big "Thank You" to Samantha Aaron, BA, CPhT of The Compounding Pharmacy, Hickory, NC.

If you find an error in any of IJPC's products please do not hesitate to let us know by emailing Lisa Ashworth, BS, RPh at lashworth@ijpc.com.

This Regulatory Update has been provided by the International Academy of Compounding Pharmacists (IACP). For more information, www.iacprx.org.

FDA Inspections, Collection of Samples Continues
Since January 2005, FDA inspectors have been visiting compounding pharmacies across the country, conducting inspections and collecting samples of certain compounded preparations, primarily bioidentical hormones and aqueous-based inhaled preparations. It appears that the FDA may have recently renewed its focus on this program, as in the past month IACP has received numerous phone calls from pharmacies that have been contacted for samples.

IACP has issued several notices to its members about these activities and has provided resources to pharmacies both to prepare for and assist during inspections. It is important to know your rights if you are visited by the FDA. To assist members, IACP has prepared a document entitled, "FDA Inspections of Pharmacies: What Should You Do?" Download a copy of the document here (requires login) or contact IACP at (281)933-8400. It is important to familiarize yourself with this document before the FDA shows up at your pharmacy.

We understand that participation in the study is voluntary, and it is worth asking any FDA agent if this is the case should they show up in your pharmacy. While it may be advisable to decline to participate in this voluntary study, those pharmacies that elect to provide a sample should keep an equivalent quantity of the submitted medication from the same lot and send the remaining medication to an independent laboratory for testing.

Most importantly, if FDA agents come to your pharmacy to collect samples, we urge you to contact Jennifer Goodrum at (281)782-9424 or L.D. King at (281)933-8400 so that we can share with you any updated information we may have on the study.

IACP Submits Comments on Proposed Texas Compounding Regulations
As mentioned in the most recent eLink, the Texas State Board of Pharmacy recently issued revisions to its rules for sterile and non-sterile compounding (see www.tsbp.state.tx.us/compounding.htm). Primary modifications to the rules include provision for office use compounding practices and the revision of sterile compounding rules to reflect changes proposed in the most recent revision of USP Chapter <797> (May 2006).

Last week, IACP submitted comments to the Texas Board of Pharmacy to address several concerns with the proposed changes. IACP's comments addressed the preliminary adoption of in-revision USP standards, a provision asking for physician documentation beyond the prescription, animal drug requirements that were more restrictive than federal requirements, and language that could require strict adherence to USP monographs.

A public hearing on the proposed new rule will be held Tuesday, February 13 at 9 a.m. at the Texas Health Professions Council Board Room (333 Guadalupe St., Tower II Room 2-225, Austin, Texas 78701). Please e-mail jennifer@iacprx.org if you will be attending.

One of the most difficult challenges in health care today is weighing the burdens and benefits of medical treatment. This is especially true in the administration of extraordinary treatments to children with cancer and other life-limiting illnesses. In the article titled Principles of Pediatric Palliative Care and Pain Control, pages 10 through 15, of our January/February 2007 issue, Dr. Alexander Peralta discusses the principles of pediatric care and emphasizes how the role of a compounding pharmacist is an integral part of the pediatric palliative care team. If you are not a subscriber you can purchase and download this article at www.ijpc.com/backissues/ArticleDescription.cfm?ABS=2508

Also, Dr. Peralta recommends reading the 2002 report by The Institute of Medicine titled When Children Die: Improving Palliative and End-Of-Life Care for Children and Their Families by Marilyn J. Field, and Richard E. Behrman. A copy of this report may be purchased through the Compounding Today online bookstore at http://compoundingtoday.com/Books/Store.cfm

Sign up today at www.IJPC.com and start your journal print and electronic subscriptions. You can download what you are currently subscribed to and purchase electronic access to our complete set of back issues.

Windows Vista!
Like to keep up with the latest operating system? In the case of the new Windows Vista, I think it is best to think about it first. If you are purchasing a NEW system, then, yes, by all means purchase one that will utilize Windows Vista to the fullest. However, if you are thinking about just loading it onto your current computer running Windows XP that you have had for awhile, don't do it. The new Vista requires a lot of resources to run fast and utilize its capabilities; something not generally required for the typical "XP" computer. So, if you are getting a new system, then "yes," go with Vista. If not, then "no," be patient and use XP until you are ready to get a new one.