Editorial: The FDA, Parenteral Drug Association (PDA), and Compounding for Clinical Studies

Last week in Washington DC, I had the opportunity, along with pharmacist Ken Hughes of Greenpark Pharmacy in Houston, of presenting a 1.5 hour session on "Managing Drug Quality in the Clinical Setting" at the 2005 PDA/FDA Joint Regulatory Conference on "The Product Life Cycle: Quality by Design, Implementation and Continuous Improvement". The thrust of the session we conducted was on quality issues in compounding for clinical studies. Pharmacist, Eric Kastango was the moderator of the session and invited our participation.

We had a great attendance at the session, which consisted primarily of individuals from the pharmaceutical industry and the Food and Drug Administration. The session started by describing pharmaceutical compounding and it's place in health care. We explained the importance of compounding and the many reasons for its growth. After this, the standards that are followed were described, including discussions on the U.S. Pharmacopeia, USP:Pharmacists' Pharmacopeia, State Boards of Pharmacy, DEA, OSHA, EPA, etc. We discussed USP Chapters <795> and <797>. Examples of compounding were presented along with pictures of these dosage forms and several different formulations so they could see the flexibility of working with a compounding pharmacist.

Next, the different types of clinical studies were briefly discussed as they may come from medical centers, clinics, foundations, etc. as well as from some pharmaceutical companies. We presented the current situation where most pharmaceutical companies will not do contract work for manufacturing clinical trial supplies and so there is no alternative but to use compounding pharmacists if the study is to be conducted.

The relationship between the pharmacist and the principal investigator of the study was discussed along with the mechanisms for working together to ensure the provision of quality compounded dosage forms for these studies. The participants were also introduced to the dualism in what is now required for compounding as compared to industry as it pertains to (1) standard operating procedures, (2) analysis of compounded preparations by FDA registered laboratories, (3) packaging and labeling, and (4) other required activities. The quality control variables were described along with how pharmacists can control these to prepare quality materials for a clinical study. Finally, the documentation that is provided was explained and detailed.

Following this, Ken presented examples of many drugs that he has compounded for clinical studies, including those for NIH studies, the Stehlin Foundation, Baylor College of Medicine, VA Hospital of Houston and the VA Research and Development service.

There were numerous public questions following the presentations and they were all supportive and the participants were very interested in this field that they knew very little about. After the session, many individuals remained and asked specific questions. One that I was particularly interested in was from an individual from a biotech firm that was explaining that they have a new product but it is only stable for 1 to 2 weeks. Is there a way that compounding pharmacists could be of help? Obviously my response was "Yes, they definitely can". In fact, as I explained, we already have a model out there in nuclear pharmacy where very short half-life drugs are prepared daily for administration within hours. Compounding pharmacies can easily work with them to prepare these items that are stable for a few days. The explanation went further to explain that we have compounding pharmacies all over the U.S. (and world) and that it is felt that a part of the future of compounding pharmacy is going to be in working with biotechnology companies in the final step of preparation that will involve compounding or manipulating of these new drug products.

Was it worth the time and money to present this information to this new audience? Very definitely! We initially had some apprehension that they may be negative; however, just the opposite happened... ...they were very supportive and wanting to know more. New doors will continue to open in this area for quality pharmaceutical compounding.

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

This week more than 40 articles related to BHRT were added to CompoundingToday.com's literature search and database and more are being added. This makes CompoundingToday.com the largest compilation of articles related to compounding and bioidentical hormone replacement therapy.

• Boothby LA, Doering PL, Kipersztok S. Bioidentical hormone therapy: A review. Menopause 2004; 11(3): 356-367.
• Kuhl H. Pharmacology of estrogens and progestogens: Influence of difference routes of administration. Climacteric 2005; 8(Suppl 1): 3-63.
• Mahaguna V, McDermott JM, Zhang F et al. Investigation of product quality between extemporaneously compounded progesterone vaginal suppositories and an approved progesterone vaginal gel. Drug Dev Ind Pharm 2004; 30(10): 1069-1078.
• McKee J, Warber SL. Integrative therapies for menopause. South Med J 2005; 98(3): 319-326.
• [No authors listed]. Bioidentical hormones. The bottom line on compounded hormones. Mayo Clin Womens Healthsource 2005; 9(9): 1-2.

This week compounders discussed the following topics on the Compounder's Network List (CNL), an email network with more than 1000 pharmacists.

• Preserved water and its toxicities
• A formula for oral glycopyrrolate solution
• Dr. John Lee and his books on progesterone and other BHRT treatments
• Snoring treatments
• A phenazopyridine suspension formula
• Topical application to keep dog from licking fur

As a service to CompoundingToday.com subscribers, relevant and informative websites will be reviewed in the newsletter and compiled on the CT.com website. Here is the first one to be included:

www.NationalPainFoundation.org
An on-line educational and support community for persons in pain, their families and physicians. The National Pain Foundation offers peer-reviewed information about pain conditions and diseases, treatment options, complementary medicine, psychological issues related to pain and much more.

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

Board of Pharmacy to Discuss Compounding Items
The Colorado Board of Pharmacy is scheduled to meet on Thursday, September 22, 2005. The agenda contains several items of interest related to compounding. Read more>>

MILT^TM 2.0 by Medi-Dose® Software
Medi-Dose, Inc. is excited to release its latest software... MILT 2.0 by Medi-Dose for our Medi-Dose, TampAlerT® and LiquiDose® packaging and labeling systems. (Medi-Dose Information Labeling Technology^TM)

Based on our successful MILT software, MILT 2.0 by Medi-Dose contains a variety of innovative features designed to keep pace with the ever-changing practice of pharmacy packaging. We've now added RSS bar coding technology to complement our large array of supported bar code symbologies. You can now bar code up to 26 characters of text when using Medi-Dose and Mini-LiquiDose labels and 30 characters when using standard LiquiDose labels.

Plus we've enhanced our dynamic formatting options to allow you to enter up to 25 characters per line while using a BOLD, Italics, Underscored or Color font to highlight text to call attention to look-alike names in order to reduce the potential for medication error.

MILT 2.0 by Medi-Dose also contains an upgradeable (through the Internet) NDC database. Simply type or scan in the NDC number from a manufacturer's container (or type the medication name) and the pertinent information about that med will appear. The information can be mapped to designated fields within the software�greatly reducing the potential for medication error. And, when Bar Coding is set within the program, the NDC number will convert to any one of 19 different bar code symbologies. This makes MILT 2.0 by Medi-Dose compatible with almost any bar code scanning system.

MILT 2.0 by Medi-Dose was designed with improved security features�including a locking function for designated information fields, a custom user setting to allow or limit access to certain operations and a label & user audit trail. These utilities allow you greater control of the continued accuracy of your data since you can limit who modifies label and log information.

And, of course, we continue to support our MINI-LiquiDose label for syringe and ampule identification. This small label (approximately 1/2" x 1 1/4") accommodates 2 lines of text AND a Bar Code (or 3 lines of text without a bar code) at 25 characters per line!

MILT 2.0 by Medi-Dose works with virtually all Windows Operating Systems (95 / 98 / NT / 2000 / XP) using our Laser Label products (MD240 series for Medi-Dose, LD1100 and LD130 series for LiquiDose). MILT 2.0 by Medi-Dose costs just $259. For current MDWIN, MD2000 and MD2001 customers, it's just a $99 upgrade. And, like always, technical support is free!

Please call us to order or for a demonstration CD and additional information. MILT 2.0 by Medi-Dose... another unique innovation from Medi-Dose, the leaders in unit dose packaging.

Medi-Dose®, Inc.
70 Industrial Drive, Ivyland, PA 18974
Phone: (800) 523-8966 or (215) 396-8600
Fax: (800) 323-8966 or (215) 396-6662
E-Mail: info@medidose.com
Web Site: http://www.medidose.com

Pulverizing Gum and Waxes

Need to pulverize gum (including gum base and chewing gum), waxes or some other ingredient that has a "plastic" or "bendable" character to it? Simply place it in a plastic baggie and set it in the freezer for about an hour. Remove it from the freezer then crush the material (still inside the baggie) using a pestle or the handle of a large spatula, etc. Return it to the freezer if it softens up and repeat the process if necessary. When finished, simply return it for 20 minutes to the freezer and then remove it and weigh out the required quantity for the preparation.