Regulatory Focus

Determining the Worst Case

How do you satisfy worst-case requirements in ISO 11607?

Sharing Supply-Chain Data

Exchanging standardized data on supply-chain events could improve patient care. But can it also satisfy pedigree requirements?

By Daphne Allen

Tracking drug and medical device movement along the supply chain could yield valuable results.

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USP Certifies Quality

Bulk shipping containers of verified drug ingredients, substances, and excipients could display the USP Verified Pharmaceutical Ingredients mark.


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ASTM Addresses Distribution Simulation and Accelerated Aging

Standards updates aim for more-realistic testing.


By David Vaczek, Senior Editor


ASTM Subcommittee F2.50 is clarifying the use of relative humidity levels in package accelerated-aging protocols to ensure more-realistic testing results. After three rounds of balloting on a revision to standard F1980-02, a fourth draft is being prepared that will be submitted to the subcommittee and full committee (F02) for concurrent voting, says Pat Nolan, chief operating officer, DDL (Eden Prairie, MN).

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Pedigree Rules Delayed Again

Manufacturers wouldn’t have been required to provide pedigrees. But despite the rules’ delay, manufacturers may decide that developing a pedigree may make good business sense.

Days after FDA’s drug pedigree rules took effect, a federal court granted a preliminary injunction on behalf of distributors to block the rules. FDA would have focused on drug products that are most vulnerable to counterfeiting and diversion. These include high-value, high-volume, high-risk drugs, some of which have already fallen victim to counterfeiters: Lipitor, Procrit, Viagra, and other drugs.

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Was There a Loophole in the Pedigree Rules?

Katherine Eban argues that FDA’s pedigree rules did not go far enough. “We need comprehensive pedigrees with no exemptions,” says the author of Dangerous Doses. First published in 2005, the book details how criminal drug diverters and counterfeiters introduced fake products into the legitimate market through secondary wholesale distribution. Eban, who has testified before Congress, calls the exemption for authorized distributors of record (ADRs) a loophole that would have left the drug market vulnerable to criminals.

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FDA Priorities

FDA had planned to give higher priority to enforcing pedigree requirements for prescription drugs that face the greatest risk of diversion and counterfeiting. Despite the rule’s delay, manufacturers may still want to work toward some sort of pedigree. If you can answer yes to any of these questions posed by FDA, your product may face a high enough risk to warrant pedigrees immediately:

Just as the pharmaceutical industry is getting acclimated to bar coding packages to help hospitals curb errors, FDA is asking whether medical devices should also bear bar codes. Calling such codes “unique device identifiers (UDIs),” the agency is urging manufacturers to share their perspectives regarding their own devices.

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RFID Standard Expands Its Reach

ISO accepts EPCglobal Inc.'s Gen2 standard, which may ease buyer concerns about RFID hardware adoption.

By Bert Moore

In July, the International Standards Organization (ISO) announced that it had adopted EPCglobal Inc.’s Gen2 standard for radio-frequency identification (RFID) hardware. According to EPCglobal, Gen2 (the full name of which is the UHF Generation 2 Air Interface standard), directs manufacturers of RFID hardware during hardware design. Gen2 was added as Amendment 1 to ISO/IEC 18000-6 as the Type C standard for ultra-high-frequency (UHF) RFID.

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