Track & Trace: Are We Talking Mars Flight When We Can't Get to the Moon?

Hedley Rees, Managing Consultant, PharmaFlow
Wednesday, October 30, 2013 11:00 EDT

This interview appears in CPhI's Annual Report, Part 2, which was formally released last week at CPhI 2013 in Frankfurt.

CPhI: What impact do you expect the EU Falsified Medicines Act and US FDASIA to have on the industry?

HR: The EU was first to legislate on adulteration and counterfeit issues in 2011. The subsequent consultation on the associated GDP/GMP tightening was fraught with issues raised by supply chain actors that would be impacted.

For example, one area of confusion was the requirement to apply for a wholesale dealer license for any company storing materials for more than 24 hours, and in the case of cold chain, licenses would be required if they were handled at all. The ensuing uproar (especially from the third party logistics providers) resulting in that requirement being abandoned, as happened to a number of the initial proposals.

Even now, there are still practical issues with the new regulations, such as the requirement for materials sourced from third countries (outside EU) to assure EU GMP equivalence. That is still a moving feast, as is the requirement to assure transparency of materials right the way up to original source -- how many Pharma companies can claim they have that?

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FDA Sets New Rules to Combat Drug ShortagesThe agency will require more notification of impending supply changes.

By Sophie Novack

October 31, 2013

The Food and Drug Administration is taking measures to further address the problem of drug shortages, The Wall Street Journal reports.

The FDA will share a new federal rule and plan on drug shortages on Thursday, which will add to an order signed by President Obama in 2011 and passed by Congress in 2012

The law will require companies to let the FDA know about any temporary manufacturing situations that would endanger drug supply, or of any plans to cease production of drugs in short supply. The agency would then find alternate manufacturers to make the drug. 

The number of notifications of coming shortages by companies to the FDA increased sixfold since the presidential order in 2011, but doctors and researchers say there is much still to do. 

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IMPORTANT! Compounding Pharmacy Legislation to Move in Congress | The Endocrine Society

Compounding Pharmacy Legislation to Move in Congress | The Endocrine Society

Mass. Senate OKs compounding pharmacy crackdown AP / October 31, 2013

BOSTON (AP) — The Massachusetts Senate has unanimously backed stricter regulations on drug compounding pharmacies like the one blamed for a deadly nationwide meningitis outbreak.

The Senate bill establishes sterile compounding and complex non-sterile compounding specialty licenses to be issued by the Board of Registration of Pharmacy. It also requires inspectors to conduct planned and unplanned inspections of pharmacies.

The vote follows passage of a similar measure by the Massachusetts House earlier this month.

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Stats: There are 36,000 family-owned compounding pharmacies in the United States

quoted from here

Senate Hotlines Compounding Bill After Agreeing To Vote On Vitter's Exchange Subsidies Amendment

Senate leaders Wednesday (Oct. 28) hotlined floor action on compounding legislation and as part of the move will vote on Sen. David Vitter's (R-LA) amendment that would bar members of Congress and cabinet officials from getting federal subsidies to help pay for health insurance on the exchanges.

from Inside Policy Health.com  Note Wednesday was October 30, rather than the 28th.

Piqua Compounding Pharmacy Issues Press Release Announcing Is First Worldwide to Add High-Tech Mixing System to Ensure Accuracy, Efficiency

PRWEB) October 31, 2013

The Piqua Compounding Pharmacy in Piqua, Ohio is the first compounding pharmacy in the world to add a Resodyn LabRAM resonant acoustic mixing system.

The system, manufactured in Butte, Montana, is routinely used in the pharmaceutical, cosmetics, and ceramics industries.

The use of the LabRAM will help the pharmacy ensure that prescription dosages contain the exact amounts of active pharmaceuticals needed for individual patients in the 98 to 102 percent range.

This technology is 30 to 50 times more accurate than other compounding pharmacies and rivals pharmaceutical manufacturers, said Jeff Hogrefe, Piqua pharmacy owner.

The pharmacy has partnered with Resodyn Corporation since August of 2012 to develop an expertise in using the high-tech equipment. The United States Pharmacopeial Convention (USP), national oversight agency for compounding pharmacies, requires that compounded products attain accuracy in the 90 to 110 percent range.

There are 36,000 family-owned compounding pharmacies in the United States

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A Practical Guide to Companion Animal Prescription Drug Labeling and & the Role of the Center for Veterinary Medicine (CVM) at the FDA

view Powerpoint here

About the Center for Veterinary Medicine Communicating

About the Center for Veterinary Medicine Communicating in 2012

Inside Health Policy: Senate Hotlines Compounding Bill The Majority Leader seek unanimous consent to pass the Drug Quality and Security Act, with one amendment from Sen. Vitter regarding insurance subsidies for Members of Congress and the Cabinet. (Busch, 10/30/13)