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July 25, 2008 Volume 5, Issue 29
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  Letter from the Editor
Loyd V. Allen, Jr., Ph.D., R.Ph.

Editorial: "New Drug", "Labeling" and the Midland Decision

From the Midland Decision:
The term "new drug" means

(1) Any drug (�) the composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof�.

It appears that a "new drug" is connected with its "labeling" and what is on the labeling is what is "evaluated for safety and effectiveness." However, in the situation of compounding, the labeling reflects a prescription for an individual patient, the labeling requirement is primarily dictated by the individual state boards of pharmacy (and others), and generally includes such things as name and address of the pharmacy, compounding pharmacist identification, reference number (batch/lot number), patient name, common name or list of ingredients, dosage form, strength, preparation date, assigned beyond-use date, directions for administration, and other information as required.

However, there is no requirement on labeling of compounded preparations for any "conditions prescribed, recommended, or suggested�." This varies from patient-to-patient, physician-to-physician, and, obviously, from prescription-to-prescription.

It appears that the definition of a new drug is dependent upon labeling, and labeling is provided by a manufacturer for a potential commercial drug product. The manufacturer makes application to obtain FDA-approval for the product, including the labeling; as this is where the "conditions prescribed, recommended, or suggested�" are required.

Another issue supporting the importance of the labeling is that the pre-1938 manufactured drugs were "exempt" from meeting certain safety requirements if they were already being marketed at that time and were "grandfathered" and were allowed to remain on the market without further regulatory approval if they were labeled with the same conditions of use. A lot of emphasis is placed by the FDA on the "label" and on "labeling."

Commercial products have detailed labeling requirements that are uniform from batch-to-batch of manufactured product. Compounded drug preparations are labeled according to the instructions of the physicians on the medication order or the prescription and are not uniform from batch-to-batch, as they are patient-specific and the formulations may differ.

It appears to me that it is inappropriate to s-t-r-e-t-c-h the "new drug labeling requirements" to compounded preparations to make them "new drugs."

Square pegs in round holes just don't work!

Loyd V. Allen, Jr., PhD, RPh

 
Other News

House committee is investigating FDA's approval of Ranbaxy's drugs while simultaneously investigating manufacturing violations of the firm.
A congressional committee is questioning how the FDA is handling allegations that Ranbaxy sold potentially adulterated medicines and whether or not the FDA knowingly allowed unsafe and ineffective medicine to enter the U.S. With allegations of "a pattern of systematic fraudulent conduct, including submissions by Ranbaxy to the FDA that contain false and fabricated information about stability and bioequivalence, why is the FDA still approving their medicines and allowing shipments into the U.S.," asks the committee?
http://www.nj.com/timesoftrenton/stories/index.ssf?/base/business-4/1216267579207410.xml&coll=5

Physicians to get paid by Medicare for e-Prescribing
Approximately 10% of physicians already e-prescribe and that number is expected to increase. There are definitely advantages in the area of patient safety, etc. Medicare will begin paying physicians to stop hand writing prescriptions and transmit them electronically.
(Note: Pharmacies have been incorporating computerization into practice for years; however, it is not evident that we get paid additional for doing that. Instead, it seems that the more efficient we get, the less we get paid!) http://ncpa.yellowbrix.com/pages/ncpa/Story.nsp?story_id=119400601&ID=ncpa

 
Book Review

International Research in Healthcare
Felicity Smith, Sally-Anne Francis, Ellen Schafheutle
Chicago, IL: Pharmaceutical Press; 2008 (www.pharmpress.com)

Many issues in healthcare are not only prevalent in our own nation but are also prominent worldwide. Therefore, it is important to be able to conduct research worldwide in order to best understand these issues. This book provides a concise overview of the processes and challenges revolving around international research in health care, such as the impact of political, cultural, and economic differences. Although the emphasis is on research at an international level, the basic principles of research are essential to all researchers at a local, national, or international scale. The book is written with logical flow, beginning with the planning of a study, to the execution of methods, to analyzing data, and finally to dissemination and conclusion. Included as illustration to various topics covered are first person accounts of problems encountered and wisdom gained from other researchers who have conducted studies internationally.

Reviewed by Wendy Chiang, PharmD Candidate (University of Oklahoma, Oklahoma City, Oklahoma)

 
New Standard Operating Procedures

13 New SOPs were added this week to www.CompoundingToday.com, including the following:

1.041.1Controlled Substances Dispensing
1.052.1FDA Negative List
1.088Drug and Chemical Selection
1.089Labeling Office Use Products
8.002.1General Compounding-Vials
8.005.03Delivery Containers
8.008.03Master Formulation Record
8.021.1Beyond-Use Dating
8.059General Compounding-Ampules
8.060Compounding a Formulation Using Software Documentation
9.035Visual Inspection of Finished Product
9.036Checking a Compound Prescription
9.037Drug Quality Defect Reporting

 
Did You Know?

�that the long-awaited Midland Decision came out last Friday. Get a copy and read it through at:
http://www.ca5.uscourts.gov/opinions/pub/06/06-51583-CV0.wpd.pdf

 
Compounding Tip of the Week

Kid's Camp Fun!
It's time for the kids to go to camp, and along with the fun there are insect bites, poison ivy, lice, and all kinds of "fun" things. Make a display in your pharmacy to help parents get prepared for when the kids return home! If you subscribe to IJPC's RxTriad, there are many published articles about these common complaints that can be helpful in the preparation of handouts for your patients.

RxTriad - The most valuable marketing tool available for compounding pharmacist.
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