To place a classified advertisement please contact: Lauren Bernick lbernick@ijpc.com or 405-513-4236

Editorial: What is Compounding Pharmacy, Part VIa: Responsibilities of a Compounding Pharmacist

The responsibilities of a compounding pharmacist go well beyond those involved in regular pharmacy practice. A compounding pharmacist is responsible for the entire scope of activities of routine pharmacy practice plus all the responsibilities associated with compounding, as listed below. It should be added that a manufacturer takes months, and even years, to develop a drug formulation, whereas a compounder has a few minutes or hours; a manufacturer has complete departments to handle each of the functions listed below, whereas a compounder is responsible for all of them; the cost of a drug from a manufacturer includes all the activities and functions in the selling price and people expect them to charge for everything in the price of the product, whereas a compounder is expected to base the price on only the cost of the "active ingredient" plus a small markup.

USP <795> states that the compounder is responsible for compounding preparations of acceptable strength, quality, and purity and in accordance with the prescription or medication order. The compounder is also responsible for dispensing the finished preparation, with appropriate packaging and labeling, and in compliance with the requirements established by the applicable state agencies, state boards of pharmacy, federal law, and other regulatory agencies where appropriate.

USP <797> states that compounding personnel are responsible for ensuring that CSPs are accurately identified, measured, diluted, and mixed and are correctly purified, sterilized, packaged, sealed, labeled, stored, dispensed, and distributed. These performance responsibilities include maintaining appropriate cleanliness conditions and providing labeling and supplementary instructions for the proper clinical administration of CSPs.

Next week, we will look at the overall/general responsibilities of a compounding pharmacist in a little more detail.

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

Taipei Pharmacists Demand Separation of Medicine and Pharmacy
More than 5,000 pharmacists and over 1,000 students studying pharmacy held a protest parade in front of the Presidential Office on June 8 calling for the separation of drug dispensing from medical practice. In Taiwan, clinics are allowed to hire drug dispensers, the association said, complaining such a "double-track" system turned pharmacists into workers for physicians. One pharmacist said physicians should not act both as practitioners and as rule makers, just as an athlete should not be a player and a referee at the same time.
http://focustaiwan.tw/news/asoc/201406080019.aspx

Italy Funding Avastin for Unapproved Use
Italy will pay for patients to use Avastin to treat an eye condition for which it's not approved, as the country looks to rein in medical costs. The decision by the Italian Medicines Agency will steer patients with age-related macular degeneration away from Lucentis, a similar but more expensive drug in Italy that regulators cleared for the same disease. Italy's antitrust authority had accused the companies of colluding to block the use of Avastin for the eyes. Other European governments may do the same as drug costs continue to increase.
http://www.bloomberg.com/news/2014-06-10/italy-to-fund-unapproved-use-of-roche-drug-to-cut-costs.html

Edible-invisible barcodes for Drugs
WuXi PharmaTech (with operations in China and the U.S.) and TruTag Technologies, Inc., developer of an edible, covert security platform that addresses global product counterfeiting, recently announced a relationship. A press release says, "This is the first time a global pharmaceutical has made the move to putting invisible, edible barcodes on medication. "
"TruTags�" are inert, edible, and can integrate into a product without packaging or labels-much like fingerprints on a human being-for the authentication of food, drugs, electronics, consumer products, and industrial components.
http://www.healthcarepackaging.com/trends-and-issues/traceability-and-authentication/invisible-edible-barcodes-medications

U.S. Can't Turn Inspections Over to Europeans
European regulators, after having completed their assessment of drug manufacturing violations at Ranbaxy Laboratories Ltd.'s facility in Toansa, India said that although deficiencies were found, they pose no risk to public health. This assessment contradicts the response of U.S. regulators to the deficiencies found at the plant. The FDA has barred Ranbaxy from making and selling pharmaceutical ingredients from the Toansa facility to U.S. consumers." The FDA will not lift its ban on Ranbaxy until it is satisfied the products meet quality standards.
http://www.reuters.com/article/2014/06/05/us-europe-ranbaxy-lab-idUSKBN0EG2FU20140605

Ex-employee of Novartis (Japan) Arrested after Clinical Data Probe
A Novartis AG (Japan unit) former employee was arrested on suspicion of manipulating data to promote the Swiss drugmaker's best-selling blood pressure drug Diovan. Nobuo Shiraishi, 63, was arrested on suspicion of violating Japan's pharmaceutical laws by providing false data to researchers, whose work was intended for use in advertising the drug.
http://www.reuters.com/article/2014/06/11/novartis-japan-idUST9N0OJ03J20140611

Become a fan of the IJPC Facebook page and share ideas, photos, and keep up to date with the latest compounding information - http://www.facebook.com/IJPCompounding

Learn about the Journal's new multi-media features and view our growing collection of educational and training videos at www.ijpc.com/videos or by subscribing to our Youtube channel at https://www.youtube.com/user/IJPCompounding.

�that we have two celebrations this weekend? June 14 is Flag Day and June 15 is Father's Day. Flag Day is celebrated on June 14 and commemorates the adoption of the flag of the United States, which happened on June 14, 1777 by resolution of the Second Continental Congress. Father's Day is a celebration honoring fathers and celebrating fatherhood, paternal bonds, and the influence of fathers in society. Father's Day was created to complement Mother's Day, a celebration honoring mothers and motherhood.

Display the flag in your facility on Flag Day and remember and honor Father's Day!

Around the curve,
Lickety-split!
Beautiful car,
Wasn't it?
     Burma Shave

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

Kelley-Ross Pharmacy, Seattle, Washington; Ryan Oftebro, PharmD, roftebro@krrph.com. Re-Accreditation for Sterile & Nonsterile Compounding

King's Pharmacy and Compounding Center, Fullerton, California; Ali Rezaei, PharmD, drcompound@gmail.com. Re-Accreditation for Nonsterile Compounding

America's Compounding Center, Newton, Massachusetts; Arthur Margolis, RPh, arthur@accrx.com. Re-Accreditation for Nonsterile Compounding

Custom Rx Pharmacy, Wichita, Kansas; Jan Gerber, RPh, jgerber@customrx.net. Re-Accreditation for Sterile & Nonsterile Compounding