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Editorial: It Just Doesn't Fit!

We will take a break this week from our continuing discussions on Current Good Manufacturing Practices (cGMP) content and talk about a related matter. What USP General Chapters are for Good Manufacturing Practices (GMPs) and which ones are for Good Compounding Practices (GCPs)?

Scenario 1: One trades in their car and purchases a new dump truck. Upon driving it home and opening the garage door, you find "It just doesn't fit!"

Scenario 2: One wants to cook a 12-pound turkey for this weekend, and it is all prepared and ready. You then try to place it an EZ Bake Oven, and you find "It just doesn't fit!"

Some are attempting to apply many USP General Chapters to compounding and finding "It just doesn't fit." Many of the chapters were never intended for compounding in the first place; but were intended for the pharmaceutical industry and manufacturing; some for both.

Up until USP XVIII (1970), the USP did not have "General Chapters"; it had a section on "General Tests, Processes, and Apparatus." Also, in the PREFACE, it stated, "However, procedures by which good manufacturing practice is implemented are decidedly related to drug standards, and consequently much of the revision embodied herein serves to necessitate and/or demonstrate compliance with what are regarded as the best practices." The USP also discusses the relationship and impact of the 1962 Amendments to the Food, Drug, and Cosmetic Act, the U.S. Food and Drug Administration and United States Pharmacopeia.

In the USP XIX (1975), the USP introduced the General Chapters, but they were un-numbered. It is apparent that these chapters were targeted at both pharmacist practitioners and manufacturers. In some cases, both practitioners and manufacturers are referred to within the same chapter. There were about 80 General Chapters and 16 sections of the General Information, Processes, Techniques, and Apparatus that remained.

In USP XX (1980), the USP began "numbering" General Chapters (i.e., <1>); there were 100 enforceable General Chapters and 19 General Information chapters. Information contained in the General Information, Processes, Techniques, and Apparatus sections was incorporated into the General Chapters.

In the last 32 years, additional General Chapters have been written. In USP 35, there are 145 General Chapters (Enforceable), 94 General Chapters (Informational), and 7 Dietary Supplement General Chapters.

It is evident for the vast majority of these chapters that they are directed to GMPs and manufacturers; some are pharmacy practice specific. However, some also apply to both, and it is in this area that we have difficulties.

It is impossible to apply many of the chapters to compounding pharmacy when they were written primarily for manufacturers because "they just don't fit"! However, there are some portions of some of the chapters that can be used, but not in their entirety. This is a vitally important project for the USP Expert Committee on Compounding to undertake and clearly delineate what chapters and what parts of some chapters are intended for compounding practitioners.

This is a request to not force the dump truck into the garage or the turkey into the EZ Bake Oven, but to use COMMON SENSE in the application of many of these chapters. After all, even though it is felt by some regulators that some action is necessary in light of recent events, it is the patient that is placed at risk by forcing standards where they are not intended when patient medications are no longer available. Quality compounded pharmaceuticals provide a "middle ground" to accommodate patients for whom medications are unavailable; that is what we should strive for!


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

Massachusetts to Allow Hospitals to Share Medications in Short Supply
Massachusetts public health regulators have given final approval to regulations that allow hospitals to share medications to address drug shortages. The rules are more sweeping than emergency measures adopted in November at the height of the meningitis outbreak by allowing the state health commissioner to grant long-term approval for certain hospitals, such as rural or small healthcare facilities that are struggling with drug shortages, to receive compounded medications from larger hospitals. State regulations have prohibited hospitals from sharing medications, and the emergency rules approved in November allowed only for temporary waivers of that rule.
http://www.boston.com/whitecoatnotes/2013/02/13/massachusetts-finalizes-rules-allowing-hospitals-share-medications-ease-shortages/Lu4RzUpy3kjBVBL68jSrDM/story.html

FDA Drops Compounding Barcode Experiment
The FDA has cancelled a proposal initiated several years ago by a compounding pharmacy that hoped to use barcodes on its medications that were shipped as a way of identifying patient use. This is, however, not the same as compounding specific drugs for individual patients with prescriptions ahead of time. The proposal, submitted by PharMEDium Services, actually dates to 2005. The FDA cites two reasons for changing its mind. First is the scandal over meningitis, which was traced to the NECC. Although the FDA was willing to consider the pilot study, the meningitis outbreak caused the agency to "re-examine" its exercise of enforcement discretion with regard to the need for valid, patient-specific prescriptions. The FDA adds that it is "particularly concerned about the large-scale distribution of compounded sterile drugs to healthcare facilities nationwide when appropriate compliance standards may not have been met�"

Second, PharMEDium failed to follow through on maintaining the circumstances under which the barcode proposal could be considered. In 2007, PharMEDium told FDA inspectors it was the responsibility of hospitals receiving its drugs to link them to patients, and there was no surveillance to ensure this was done; FDA issued a warning letter. A few months later, the FDA could not establish patient linkage when following up eight cases of a bacterial infection in hospitals in Maryland and California that may have been linked to one of its drugs, but neither hospital was able to do so. Also, a 2010 inspection found that PharMEDium was still failing to provide and maintain specific information that would link patients to its drug.
http://www.expertbriefings.com/news/fda-dumps-bar-code-experiment-with-compounder/

FDA Issues New Warning on Fake Avastin
The FDA has issued another warning about another counterfeit version of the cancer drug Avastin; the third case involving the best-selling Roche drug in the past year. At least one batch of the drug distributed by a New York company does not contain the active ingredient in real Avastin. The drug was distributed by Medical Device King, which also does business as Pharmalogical, and the vials are packaged as Altuzan (the Turkish version of Avastin that is not approved for use in the U.S.).
http://news.yahoo.com/fda-warns-fake-batch-cancer-drug-avastin-155524363--finance.html

The APhA Complete Review for Pharmacy
10th Edition
Gourley D, Eoff III JC
1,046 Pages; 8.5 � 11" Softbound; $66.95; January 2013

The standard licensing examination for the U.S. is the North American Pharmacist Licensure Examination (NAPLEX). This book is a current, one-volume compilation of pharmacy information that is of great value in preparation for taking the NAPLEX exam. There are 41 chapters (including a new chapter on Nuclear Pharmacy) and fourteen appendices. It is designed to meet either student's or practitioner's needs for easy use and focused details on pharmacy practice. This book is an excellent tool for preparation for the exam as well as for reviewing current practice information. It is highly recommended.

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�that Valentine's Day expressions have gone from handwritten valentines TO mass-produced greeting cards TO digital e-mails? Drug stores used to be the center of sales for Valentine's Day cards and candy! My, how things have changed!

Consider donating unsold Valentine's Day candy and items to a charity while they are still fresh and others can enjoy them!

Said Juliet
To Romeo,
If you won't shave,
Go homeo!
      Burma Shave