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To all: We will interrupt our series on "What is Compounding Pharmacy?" to bring you this very, very important announcement. PLEASE READ!!!!

In an effort to answer stakeholder questions, USP will hold an open microphone web meeting on June 12, 2014 (2:00 pm - 4:00 pm EDT) to discuss the proposed General Chapter <800> Hazardous Drugs - Handling in Healthcare Settings. The purpose of the new general chapter is to provide standards to protect personnel and the environment when handling hazardous drugs (HDs). Each year, approximately 8 million U.S. healthcare workers are potentially exposed to HDs. The new proposed general chapter defines processes intended to keep the exposure of HDs to as low a limit as is reasonably achievable.

The agenda of the session will include:

• An overview of USP
• Background on the proposed General Chapter <800> Hazardous Drugs - Handling in Healthcare Settings
• An opportunity for participants to ask questions about the proposed general chapter
• Information about how to submit public comments on the proposed general chapter

The proposed General Chapter <800> along with a recorded overview of the general chapter is available at http://www.usp.org/usp-nf/notices/compounding-notice. The comment period for General Chapter <800> will end on July 31st, 2014.

If you would like to participate in the open microphone web meeting, please register at https://uspevents.webex.com/uspevents/onstage/g.php?d=667866995&t=a by 5 pm on June 11th, 2014. Space may be limited, so please register as soon as possible. If you are unable to participate, the web meeting will be recorded and posted on the USP website.

Note: This is very important, so please take time to participate! If you don't, please don't complain about it later. Having volunteered for over 30 years with the USP (until October 2013), it is critically important to provide input for consideration by the current USP Expert Committee on Pharmacy Compounding. As I have heard it said so often, "You snooze, you lose!"

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

"Right to Try" Experimental Drugs
The "Right to Try" bills could help terminal patients. The principle is straightforward: When you face a terminal disease, you may, under a doctor's supervision, try promising experimental drugs before they're given final FDA approval. This will not open the door to charlatans. "Right to Try" bills would apply only to promising medicines that have cleared Phase 1 of an FDA-approved safety trial and are still under clinical development in an FDA trial. The supporters state "We think it's simple: Every American should have the right to try to save his or her own life."
http://www.usatoday.com/story/opinion/2014/05/28/drugs-fda-approval-right-try-legislation-column/9692735/

$84,000 in U.S. Per Patient; Much Less in the United Kingdom
Shocked by the rapid adoption of a new $84,000 hepatitis C treatment, U.S. health insurers are trying to make sure they aren't blindsided by other drugs being developed and are looking for ways to limit their use from the day they are launched. Manufacturer Gilead Sciences Inc. says 30,000 people have received the hepatitis drug Sovaldi so far, and that sales hit a record-breaking $2.3 billion within a few months. The treatment, typically 84 tablets taken over 12 weeks, completely cures the disease in more than 90% of patients. By law, insurers cannot deny access to new drugs if they represent a real improvement for patients, leaving drug companies with the upper hand in most price discussions.
http://www.reuters.com/article/2014/05/28/usa-healthcare-hepatitisc-insight-graphi-idUSL1N0OE00T20140528

Hepatitis C Drug Boost Supported by Medicare Test Plan
Medicare will cover the cost of screening for hepatitis C, a decision that may further open the government's wallet for Gilead Sciences $84,000 cure for the disease. High-risk adults, including those who inject illegal drugs or had a blood transfusion before 1992, are eligible, as is anyone in Medicare ages 49 to 69. A hepatitis C diagnosis could lead to the use of Gilead's Sovaldi at a cost of $84,000 for a 12-week course of treatment.
http://www.bloomberg.com/news/2014-06-03/gilead-hepatitis-c-drug-boost-seen-on-medicare-test-plan.html

Over 10,000 Bottles of Promethazine Recalled by India's Zydus Cadila
Indian drugmaker Zydus Cadila has recalled over 10,000 bottles of promethazine hydrochloride due to the presence of atenolol in a bottle instead of the labeled drug. The recall was voluntarily initiated by the company's U.S. unit, Zydus Pharmaceuticals USA Inc., on May 8; the FDA classified the recall as Class II, meaning the use of or exposure to the recalled products may cause temporary or medically reversible adverse health consequences.

This drug recall is the seventh this year by an Indian company, and follows those by other large drugmakers including Wockhardt Ltd, Ranbaxy Laboratories Ltd, Dr. Reddy's Laboratories Ltd, Lupin Ltd, Sun Pharmaceutical Industries Ltd, and Glenmark Pharmaceuticals Ltd. The incidents come at a time when the FDA has increased its scrutiny of Indian drugmakers after the agency banned exports from manufacturing plants of some top drugmakers, including Ranbaxy and Wockhardt, upon finding quality-control lapses.
http://www.reuters.com/article/2014/05/30/us-zydus-cadila-recall-usa-idUSKBN0EA0VC20140530

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�that if you don't participate and respond when given the opportunity, your voice WILL NOT be heard?

Review in DETAIL, USP Chapter <800> and let them know how you feel about this new enforceable chapter before it becomes official. It applies not just to compounding pharmacies, but to ALL pharmacies (dispensing included).

The midnight ride
Of Paul for beer,
Led to a warmer
Hemisphere!
     Burma Shave

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

Harvest Drug & Gift, Wichita Falls, Texas; Janet Beard, RPh, janet@harvestdrug.com. Re-Accreditation for Sterile & Nonsterile Compounding

Pine Pharmacy, Williamsville, New York; Joseph Catanese, PharmD, ziblut@gmail.com. Re-Accreditation for Sterile & Nonsterile Compounding

Long Beach Pharmacy, Long Beach, Washington; Jeffrey Chabot, RPh, lbcompounder@centurytel.net. Initial Accreditation for Nonsterile Compounding

Hawthorne Pharmacy on Taylor, Columbia, South Carolina; Wendy Lee, PharmD, wendyl@hawthornesc.com. Initial Accreditation for Sterile & Nonsterile Compounding

Nekos-Dedrick's Pharmacy, Kingston, New York; Renee Nekos, PharmD, rnekos@nekosdedricks.com. Re-Accreditation for Sterile & Nonsterile Compounding

Pacifica Pharmacy, Torrance, California; Jeff Barris, PharmD, pacificarx@gmail.com. Re-Accreditation for Nonsterile Compounding