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FDA shuts down Long Island company for non-compliance to dietary supplement cGMPs

BY Michael Johnsen

SILVER SPRING, Md. — The Food and Drug Administration on Wednesday shut down a company for noncompliance of the dietary supplement current good manufacturing practice requirements. 
 
"Triceutical of Farmingdale, New York, and Liqun Zhang, the company’s president, have agreed to stop production and distribution of dietary supplements under the terms of a consent decree because of violations of federal dietary supplement regulations," the agency stated. "Triceutical, under the FDA’s supervision, is required to recall and destroy all dietary supplements that were manufactured, prepared, packed, repacked, labeled, held and/or distributed since Feb. 6, 2012, in accordance with the procedures in the consent decree. The consent decree was entered by U.S. District Judge Leonard Wexler of the Eastern District on July 8, 2014."
 
The FDA issued Triceutical a warning letter dated Nov. 8, 2012, that outlined serious violations of cGMP requirements, including failure to perform tests to verify the identity of dietary ingredients used to manufacture the dietary supplements. Follow-up inspections by the FDA revealed that Triceutical failed to take adequate corrective actions to correct that violation and to ensure the manufacturing process complied with cGMP requirements. Failure to follow cGMP requirements made Triceutical’s products adulterated under the Federal Food, Drug and Cosmetic Act.
 
“When a company violates good manufacturing practice requirements, they put consumers at risk,” stated Melinda Plaisier, the FDA’s associate commissioner for regulatory affairs. “Our goal at the FDA is to ensure that the dietary supplements consumers have access to meet federal standards for safety, effectiveness and quality."
 
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Report: Hy-Vee reaches agreement for first Twin Cities location

BY Antoinette Alexander

WEST DES MOINES, Iowa — Grocer Hy-Vee, which operates more than 230 stores and generates sales of more than $8 billion, has reached a deal for its first Twin Cities location, according to a local news report.

According to a report by the Minneapolis/St. Paul Business Journal, the company has reached an agreement with New Hope’s city council and will buy land once occupied by a Kmart.

Hy-Vee is looking to build a 90,000-sq.-ft. grocery store and 3,000-sq.-ft. gas station at the site.
 

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VoicePort licenses 11 Walgreens patents in the field of prescription alignment

BY Michael Johnsen

ROCHESTER, N.Y. — VoicePort on Thursday announced a patent licensing agreement with Walgreens that covers 11 U.S. patents and patent applications owned by Walgreens in the field of prescription alignment. 
 
"VoicePort's Synchro-Script technology works best for everyone when it is backed with robust intellectual property and patents," said Christopher Mann, VoicePort CEO. "We are pleased to have agreed upon a solution that allows our customers to purchase Synchro-Script products from VoicePort with confidence. In addition, VoicePort is pursuing a number of patent applications for other inventions involving our Synchro-Script technology."
 
Medication Synchronization is an industry solution that has proven to improve patient adherence through a multiple-tier touch point. "Allowing pharmacy patients the opportunity to pick up multiple prescription medications once a month has shown to significantly improve a patient's Proportion of Days Covered on their medications," said Alphonse Sasso, VoicePort VP business development. "When consumers stay adherent to their maintenance medications, it translates to improved patient health outcomes while also increasing pharmacy efficiencies, a true win-win solution." 
 
VoicePort's systems leverage their proprietary pharmacy informatics platform, PharmaPhonetics, as a dynamic analysis tool to help pharmacists and staff identify patients eligible to participate in the program. The platform then offers anchor medication recommendations that the pharmacy team can align to get all meds on a once a month schedule and calculates the required short fills necessary to help the pharmacist complete the task for the patient. Each pharmacy also is supported with an automated calling system from VoicePort to enroll patients in the synchronization program, to schedule the pharmacist-patient counseling sessions, and to alert patients when their medications are ready for pick up. VoicePort also provides back-end analytical tools to help measure pharmacy progress on keeping patients on schedule with their medications; a complete turn-key solution to help deliver greater patient health and wellness. 
 
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