PHARMACY

NPA launches warning letter database

BY Gina Acosta

WASHINGTON – The Natural Products Association has launched a free online tool for NPA members to view violations against the dietary supplement Good Manufacturing Practices.

Regulatory, compliance and QA/QC personnel of dietary supplement manufacturing facilities and retailers can use this information to monitor and track the top GMP violations by year and see how those trends are changing. The database will also allow end users to create their own reports.

“NPA is proud to announce a database for the industry that is more than just warning letters," said NPA CEO Dr. Daniel Fabricant. "It differentiates itself by capturing enforcement actions from various agencies. While it is searchable in many different ways you would think a warning letter database would be, it is also being designed to search disease claims/claim categories and allow for customized reports by member end users.”

The database is also beneficial for those responsible for labeling compliance to avoid the introduction of misbranded products into interstate commerce and those marketing with claims. The database also tracks enforcement actions taken by various agencies against companies. NPA wants their members to be able to view the entire scope of federal actions against the industry beyond a warning letter, including seizures, injunctions, forfeitures, and criminal actions.

“The benefit to industry is to learn, grow, and mature as a collective whole by correcting any mistakes or oversights now that someone else may be doing. FDA does not provide GMP compliance education, nor does it track these parameters for the industry. Industry stakeholders need these types of tools to see how the industry is adapting to change and improving their compliance.”

The database contains over 440 Warning Letters that have been publicly released by FDA, in addition to the enforcement actions taken by DOJ, FDA, and FTC since 2008.

The database is searchable by company name, product name, issue date, regulation, disease claims/claim category, and FDA action taken.

The comprehensive database is a valuable tool not only for dietary supplement manufacturers, but also retailers or consumers who want to see if FDA has found any issues with a company’s GMPs before purchasing their products. NPA will update the database weekly as new warning letters and enforcement actions are added through various public and federal agency media outlets.

 

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Report: Teva, Mylan may buy Pfizer’s overseas generic business

BY Gina Acosta

Teva Pharmaceutical and Mylan have shown preliminary interest in a Brazilian generic drug-making joint-venture in which Pfizer has a 40% stake, according to Fortune. (Fortune)

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Benzer Pharmacy opens 3 new stores as franchise model builds momentum

BY Gina Acosta

TAMPA, Fla. — Independent chain Benzer Pharmacy has opened three new stores through its franchise model.

Franchisee Hetal Patel is opening a new pharmacy in Clermont, Fla., while franchisee Harry Patel, Siddharth Patel and Chetna Patel are opening another pharmacy in Immokalee, Fla. The third store is being opened in Poteau, Okla., by Jinal Desai.

Benzer Pharmacy, a chain of independent retail and specialty pharmacies, introduced its franchise model early this year with an aim of providing independent pharmacies with a platform to leverage their collective strength under one brand.

The company CEO Manish Patel, and president Alpesh Patel, said they are both excited about this new partnership. “Through the franchise model, Benzer Pharmacy will be in a strong position to negotiate prices with drug manufacturers,” Manish Patel said. 

Benzer Pharmacy says its franchisees receive: the credibility and recognition of a large national brand, reduced cost of goods and expenses, full access to expert HR, marketing, accounting, compliance and operational support, cutting edge business coaching to optimize all the key areas of operations, and access to the full spectrum of specialty medications.
 

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