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Editorial: What is Compounding Pharmacy, Part III

In this issue, we will look at the extent of pharmaceutical compounding as it relates to various practice sites and some numerical estimates applied to compounding. Compounding can occur in all of the following practice sites (Sterile and/or Nonsterile):

• Independent pharmacies (over 75% compound; Source NCPA)
• Hospital pharmacies (almost all compound)
• Chain store pharmacies (may have designated stores for compounding)
• Nuclear pharmacies (all compound)
• Mail order pharmacies
• Pharmaceutical industry (investigational drug study compounding)
• Governmental pharmacies (military, VA, USPHS, etc.)
• Home infusion pharmacies
• Specialty pharmacies
• Veterinary Hospitals
• Veterinary Pharmacies
• Nutritional Pharmacies
• Physician offices
• Oncology pharmacies and clinics
• Regional "compounders"
• Close door pharmacies
• Large scale compounders with interstate distribution

Numerical estimates for compounding are quite variable but generally range from 1% to 10% of all prescriptions/medication orders. Actually, the number is reflective of the scope of compounding considered for the "number." For example, if one only looks at independent pharmacies, then the number would be "low". However, looking at independent pharmacies and hospitals pharmacies, the number jumps significantly. Incorporate veterinary compounding, and it jumps again. Include all the above compounding sites, and it is significantly larger at an estimated 10% of prescriptions.

However, another issue is "what is a prescription" or "medication order" and "what/how is it counted"? So it becomes a "numbers game." Reasonable estimates have placed all compounding at approximately $20 billion per year and growing. Many factors contribute to this as we have discussed in this column previously.

Next week, we will look at some definitions of compounding pharmacy.

Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition

FDA Misusing Draft Guidances? U.S. Senate Wants to Know!
Some Senators want some answers from FDA commissioner Dr. Margaret Hamburg about their practice of issuing draft guidance documents. Four Republican senators are asking FDA commissioner Dr. Margaret Hamburg for some answers on the agency's practice of issuing draft guidances to cover medical devices and drug review policies. The senators say they're concerned that the draft guidances are being used by the FDA "to make substantive policy changes." The senators wrote:

Stakeholders tell us that draft guidances are increasingly becoming default FDA policy and position. Draft guidances state that the 'guidance document is being distributed for comment purposes only.' However, in the absence of finalized guidance, drafts are the only information that FDA review staff, patients, clinicians, and FDA-regulated entities have on the agency's most current thinking on important issues.

Another concern the senators voiced is that "these draft guidances are not being revised, finalized, or withdrawn in a timely manner," according to the letter.
http://www.massdevice.com/news/senate-republicans-want-answers-fda-commish-hamburg-draft-guidances

Should Drug Companies Advertise their Prices?
If prescription drug ads routinely contained prices, would patients ignore important information about safety and effectiveness? Today, very few ads contain pricing or make cost comparisons, and the FDA is concerned such data may become a serious distraction. To address this, they are planning a study to understand how pricing data may be perceived and the extent to which safety and effectiveness information can sway any impression that "price is the main factor to consider."
http://blogs.wsj.com/corporate-intelligence/2014/05/13/fda-asks-what-would-happen-if-drugs-advertised-their-price/

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�that IACP's Compounders on Capitol Hill starts this weekend?

If you have not registered or thought about attending IACP-CCH, please reconsider, as your presence and support is especially needed at this time!

These three prevent
Most accidents,
Courtesy, caution,
Common sense!
     Burma Shave

PCAB is proud to announce the accreditation of the following pharmacies:

Health Dimensions, Inc., Farmington Hills, Michigan; Scott Popyk, spopyk@hdrx.com. Re-Accreditation for Sterile & Nonsterile Compounding

Sunlake Pharmacy, Lutz, Florida; Brian Bower, brian.bower@PSCRX.com. Initial Accreditation for Nonsterile Compounding

Triangle Compounding Pharmacy Inc., Cary, North Carolina; Danny Barnes, PharmD, pharmdmb@gmail.com. Re-Accreditation for Sterile & Nonsterile Compounding

Westchase Compounding Pharmacy, Tampa, Florida; Silas Raymond, PharmD, sraymond@westchasepharmacy.com. Initial Accreditation for Sterile & Nonsterile Compounding

Puja Enterprise, Inc. DBA: The Medicine Shoppe, Tampa, Florida; Rasesh Patel, RPh, medshop1829@gmail.com. Initial Accreditation for Nonsterile Compounding