Brought to you by the International Journal of Pharmaceutical Compounding
April 7, 2006 Volume 3, Issue 14
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  Letter from the Editor
Loyd V. Allen, Jr., Ph.D., R.Ph.
Editorial: First Pharmaceutical Compounding Quality Assurance Seminar

Many thanks to the sold-out crowd of the first Pharmaceutical Compounding Quality Assurance Seminar, which was supported by Spectrum Laboratories, Analytical Research Laboratories (ARL), and the International Journal of Pharmaceutical Compounding (IJPC). "Developing a Quality Compounding Practice that Meets and Exceeds USP Standards" was held in Oklahoma City this past weekend (April 1-2). Participants were actively involved in a "first of its kind" educational experience for pharmacy compounding.

The first session began with presentations on the source and scope of quality control in pharmacy compounding (Loyd V. Allen, Jr, PhD, RPh; IJPC), followed by in-house and out-sourced testing issues (Tom Kupiec, PhD; ARL). The final topic was on the Pharmacy Compounding Accreditation Board (Ken Baker, JD, RPh; Executive Director).

The participants were divided into two groups for the second and third sessions. Each group participated in a more detailed seminar on quality issues related to United States Pharmacopeia Chapters <795>, <797>, and <1075>, and practical issues related to their implementation. The groups also participated in four hours of "hands-on" laboratory exercises with practical experience on the use of different analytical and microbiological methods in testing compounded preparations. These exercises included specific gravity, spectroscopy, sterility, endotoxin, refractive index, osmolality/tonicity, viscosity, gas chromatography, high-performance liquid chromatography, melting point, microscopy, and pH. In addition, the group was introduced to a new research-grade spectrophotometer by way of a demonstration. The spectrophotometer, which can be used in a compounding pharmacy, uses 2 microliters of sample and provides results in 10 seconds.

We want to thank all the participants who attended the seminar, and we look forward to the next program, which is tentatively scheduled for September 2006.



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

 
CompoundingToday.com's Citation Database is Growing

CompoundingToday.com continues to expand its online, searchable database of compounding related literature. This week forty items were added on COPD with emphasis on drug delivery by inhalation, as well as seven items on miscellaneous topics mentioned on the IJPC Compounder's Network List (CNL). Some examples of this week's additions are:

  • Dolovich MB, Ahrens RC, Hess DR et al; American College of Chest Physicians; American College of Asthma, Allergy, and Immunology. Device selection and outcomes of aerosol therapy: Evidence-based guidelines: American College of Chest Physicians/American College of Asthma, Allergy, and Immunology. Chest 2005; 127(1): 335-371.
  • Drobnic ME, Sune P, Montoro JB et al. Inhaled tobramycin in non-cystic fibrosis patients with bronchiectasis and chronic bronchial infection with Pseudomonas aeruginosa. Ann Pharmacother 2005; 39(1): 39-44.
  • O'Callaghan C, White J, Jackson J et al. Delivery of nebulized budesonide is affected by nebulizer type and breathing pattern. J Pharm Pharmacol 2005; 57(6): 787-790.
  • Poole PJ, Black PN. Preventing exacerbations of chronic bronchitis and COPD: Therapeutic potential of mucolytic agents. Am J Respir Med 2003; 2(5): 367-370.
  • Rau JL, Restrepo RD. Nebulized bronchodilator formulations: Unit-dose or multi-dose? Respir Care 2003; 48(10): 926-939.

 
Manufactured Medication Shortages that Might Affect Your Practice

The following medications are in short supply. More information can be found at www.ashp.org/shortage/.

  • Calcium gluconate injection
  • Carvedilol tablets
  • Cephalosporin injectables (several)
  • Cisplatin injection
  • Corticosteroids, injectable
  • Fluorouracil injection
  • Mechlorethamine hydrochloride injection
  • Methotrexate injection
  • Multivitamin pediatric, injectable
  • Procarbazine capsules
  • Protamine sulfate injection
  • Scopolamine transdermal

 
Immune Globulin Intravenous Shortage Information Requested

The US Food and Drug Administration (FDA) received reports of problems obtaining immune globulin intravenous (IGIV) products. The FDA has not found "clear evidence" of a shortage of IGIV products and would like to hear about instances when a specific product is difficult to obtain. Reports can be filed at www.fda.gov/cber/shortage/shortage.htm#igiv.

 
Compounder's Network List Sets New Record

With over 700 posts, March was the busiest month on the CNL since its inception (January 2003). Thanks for the great discussions! Examples of some of the topics discussed on the CNL during the past week are:

  • Donepezil in Pluronic lecithin organogel
  • Dyclonine 1% oral solution formula needed
  • Glycerin soap enema
  • Papaverine and combination topical gels used to treat erectile dysfunction
  • Query about the use of forskolin in a double, triple, or quad erectile dysfunction injection
  • Request for a source for Reserpine
  • Request for a formula for the discontinued product "Vehicle n Mild"
  • USP sterility tests and extended beyond-use dating
  • Wyeth Hormone Replacement Therapy Petition

Don't miss another discussion on the list! Sign up today at CompoundingToday.com/CNL

 
Compounding Tip of the Week

Better Exhaust System Ductwork
When designing an exhaust system to remove air and particulates from a nonsterile work area (e.g., powder hood), use smooth-surface ductwork, not the accordion-type ducts. The reason is that powders will collect in the "valleys" of the ductwork and when the system is turned off and a change in pressure results, the powder may drift back into the room. Even though the accordion ductwork is easier and cheaper to install, in the long run, the smooth ductwork will be more cost-effective.

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