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DCGI issues show cause notice to e-pharmacies for stocking & selling drugs in contravention to D&C Act

AuroBlog - Aurous Healthcare Clinical Trials blog

The Drug Controller General of India (DCGI) has issued a show cause notice to online pharmacies including Tata 1mg for allegedly stocking and selling drugs in contravention of the provisions of the Drugs and Cosmetics Act, 1940 and Rules, once again bringing back the long pending issue of lack of regulations on e-pharmacies under the […]

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TN DCA issues circular asking pharmacists in medical shops to wear white coat and badges

AuroBlog - Aurous Healthcare Clinical Trials blog

Although provisions of the Pharmacy Practice Regulations (PPR) 2015 are not there in the Drugs and Cosmetics (D&C) Act 1940 but are framed under the Pharmacy Act 1948, the steps now being taken by the drugs control administration (DCA) in Tamil Nadu in a motive to strengthen the dispensing activities in pharmacies are completely agreeing […] (..)

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Arkansas Law Prohibiting Manufacturer 340B Contract Pharmacy Restrictions Upheld by 8th Circuit

FDA Law Blog

By Faraz Siddiqui — As drug manufacturers battle the Health Resources and Services Administration (“HRSA”) in federal courts over the role of 340B contract pharmacies, an Eighth Circuit decision to uphold a 2021 Arkansas law may render those cases inconsequential in that state. Code Ann. § 23-92-604(c)(1), (2) (Act 1103).

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The D.C. District Court Slaps Down on Procedural Grounds FDA’s 20-year Effort to Implement its Memorandum of Understanding to Address Interstate Shipments of Compounded Drug Products

FDA Law Blog

This time, “David” consists of a cast of seven compounding pharmacies and their amicus curiae supporters. See Federal Food, Drug, and Cosmetic Act (“FDCA”) Section 503A(b)(2). In signatory states, compounding pharmacies are subject to a 50% “threshold” and certain reporting requirements.

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FDA opens door to expressly permit personal drug importation, and yet…

Pharmacy Checkers

That is pursuant to Section 804 of the Food, Drug and Cosmetic Act. Unlike wholesale importation, Section 804 does not legalize personal importation from Canada or other countries, but it does permit it through enforcement discretion, regulation or waiver. This authority is granted by Section 804(J2) of the Food, Drug and Cosmetic Act.

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HPM Welcomes 15-Year DOJ Veteran, John W.M. Claud, to the Firm

FDA Law Blog

At DOJ, Mr. Claud prosecuted and supervised complex criminal and civil trial litigation and investigations under the Food, Drug, and Cosmetic Act, Federal Trade Commission Act, Consumer Product Safety Act, and Federal data privacy laws.

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Is License Compulsory For Starting Pharmaceutical Business In India?

Fossil Remedies

In a pharma business, you have a distribution network like a pharma manufacturing company, pharma marketing company, C&F agents, wholesalers/distributors/stockiest, retailers, and pharmacies. The government, therefore, imposes rules and regulations to acquire a drug license. In the end, there are patients or customers.