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Letter from the Chair
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Welcome to the first edition of the 2012 IPEC Insider! IPEC-Americas has a lot to look forward to this year, and as we wrap our 20th year of existence, I thought it might be worthwhile to share with you our most recent accomplishments. More

January is IPEC-Americas Safety Committee Month!
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Read About IPEC-Americas Safety Committee Activities<>

IPEC Safety Committee — Recent Accomplishments
1. The Safety Committee discussed the promotion of the IPEC New Excipient Safety Evaluation Procedure. Several articles will be published this year in the newsletters for CRS, AAPS, RAPS and PDA publicizing the IPEC Safety Procedure. In order for the Procedure to be successful, IPEC member companies must start using the Procedure to support the use of their new excipient products.

3 Day Excipient GMP Auditing Workshop
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Arlington, Va.(DC Metropolitan area) March 13-15, 2012
$1850 for IPEC-Americas Member Company Employees / $2250 for Non-members

16 spaces open! This popular workshop offers participants training in the assessment of excipient manufacturer conformance to appropriate GMP requirements. Training will analyze the essential elements of excipient good manufacturing practice for materials intended for use in pharmaceuticals or dietary supplements.

IPEC India Being Formed
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During its November meeting in Strasbourg, France, members of the IPEC Federation Board of Directors voted to accept an application from national pharmaceutical companies and international companies doing business in India to form an IPEC India as part of the IPEC Federation. Legal formation of the Council in India is expected to be completed before the end of January. Following this, membership invitations to excipient manufacturers, distributors and finished pharmaceutical product suppliers in India will be widely circulated. These will be accompanied by a description of IPEC global progress to date and ongoing programs. More

USP GDP-Supply Chain Integrity
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According to recent newsletters from the Pharmaceutical Cargo Security Coalition and Pharmaceutical and Medical Packaging News, a draft of the planned USP General Chapter <1083> developed by its Packaging, Storage, and Distribution Expert Committee will be posted this month on the USP website. The proposed general chapter <1083> Good Distribution Practices-Supply Chain Integrity also will be published in the March/April Pharmacopeial Forum for public comment. It is reported that the guidance includes supply chain practices for finished pharmaceuticals, medical devices, drug components, as well as products sold through internet pharmacy. More

FDA Notice on Gluten in Drug Products
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During recent telecons with members related to FDA issues and possible problems, several mentioned a Dec. 21 Federal Register notice on

"Gluten in Drug Products; Request for
Information and Comments" at

IPEC-Americas Sponsors ICH Q3D Metal Impurities Workshop
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April 4–5, 2012
Marriott Bethesda North Hotel, Bethesda, Md.

IPEC-Americas plans to offer a workshop to discuss the ICH Q3D Metal Impurities Guideline. New limits are being recommended that may have a direct impact on your business.
Join us on April 4-5 at the Marriott Bethesda North hotel in Bethesda, Md.! Program outline and speakers are under development and will be announced shortly. This workshop will offer an opportunity to confidentially share data and then have it taken back to ICH for consideration.

Proposed USP General Information Chapter
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As announced in Pharmacopeial Forum Vol. 37, No. 6, and also posted on the USP website at, the <1197> Good Distribution Practices for Bulk Pharmaceutical Excipients Expert Panel has published its proposed general information chapter for public comment. The deadline is Jan. 31, 2012 and comments should be forwarded to Catherine M. Sheehan, Director, Food and Excipient Standards in USP's Division of Standard Development by email to More

Drugmaker Sees Boost from FDA
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BioDelivery Sciences International anticipates that new federal regulations for narcotic painkillers used by cancer patients will level the playing field for its drug Onsolis. A new program adopted by the Food and Drug Administration removes regulatory disadvantages that Onsolis has faced in the marketplace, according to the Raleigh, N.C.,-based company. Onsolis is an oral pain patch for cancer patients suffering from pain that isn't alleviated by patients' regular medications. More

Shortage of ADHD Drug Adderall Persists
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A shortage of Adderall, which is used to treat attention deficit hyperactivity disorder, shows little sign of easing as manufacturers struggle to get enough active ingredient to make the drug and demand climbs. Adderall, a stimulant, is a controlled substance, meaning it is addictive and has the potential to be abused. The Drug Enforcement Administration tightly regulates how much of the drug's active pharmaceutical ingredient (API) can be distributed to manufacturers each year. More

Pharmaceutical company warns of Opana, Percocet painkiller shortages
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Painkillers like Percocet and Opana from Endo Pharmaceuticals may be in short supply after their production facility was shut down for manufacturing and quality issues, the company warned. Novartis, the maker of certain painkillers for Endo, said it was shutting its plant in Lincoln, Neb., to fix problems such as pills getting chipped or broken in the production process, or medications getting mixed. More

Critical Quality Considerations for Probiotics Offered in New Draft FCC Standards
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With strong consumer interest in probiotics — and new manufacturer innovations for incorporating these ingredients into a broader array of food products — new standards to help ensure the quality of probiotic food ingredients are being proposed for public review and comment. The draft standards, which will be included in the Food Chemicals Codex (FCC), offer comprehensive information that is essential when utilizing probiotics as food ingredients, including testing to confirm the identity upon which probiotic product safety and health claims are based. Published by the U.S. Pharmacopeial Convention , the FCC is an international compendium of quality specifications for food ingredients. More

Pharma-Doctor Gift Ban Generated Lots of Talk, No Final Action in 2011
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Despite strong signals that Gov. Deval Patrick, the House and the Senate would support peeling back parts of a three-year-old ban on gifts from pharmaceutical companies to doctors — a policy that critics say is strangling the restaurant business and killing jobs — 2011 is coming to a close without action. But efforts to dismantle components of the ban are poised to reemerge in 2012 and received the fresh backing of a panel of lawmakers, potentially teeing up the issue for consideration during debate on a major health care system overhaul eyed for next year. More

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