New EU GDP Guidelines Published

Quality and integrity of medicinal products are key factors that must be maintained during the entire supply chain from the manufacturer to the patient. The European Commission revised the guidelines that lay down appropriate tools to assist wholesale distributors in conducting their activities and to prevent falsified medicines from entering the legal supply chain.

Wholesale distribution of medicinal products is defined as "all activities consisting of procuring, holding, supplying or exporting medicinal products, apart from supplying medicinal products to the public. Such activities are carried out with manufacturers or their depositories, importers, other wholesale distributors or with pharmacists and persons authorized or entitled to supply medicinal products to the public in the Member State concerned."

The revised EU GDPs, Good Distribution Practices, become effective September 8, 2013.
Guidelines of 7 March 2013 on Good Distribution Practice of Medicinal Products for Human Use (2013/C 68/01)

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FDA Closes Down Another Dietary Supplement Company

Updated September 17, 2024

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Dietary Supplements - FDA

---  the original post follows below  ---

Another dietary supplement company, PUH, closed down by FDA:

"Pharmacist’s Ultimate Health of St. Paul, Minnesota agreed to a consent decree to cease their unlawful distribution of unapproved new drugs and adulterated dietary supplements. They have to stop distributing their products until all disease claims are removed from their websites and product labels and they comply with cGMP requirements for dietary supplements.

The company marketed products capsules, topical creams, and botanical extracts under the brand names Pharmacists Ultimate Health and Doctor’s Natural Therapy. The product names include Allergy Relief Complex, Lycopene Standardized Extract, Co Q-10, Cold and Flu Defense, Cholesterol Homocysteine, Prostate Companion, Ginger Root Standardized Extract, and Progesterone Cream, among others."

'via Blog this'

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FDA Restricts Cigarette and Tobacco Sales and Distribution

I don't smoke, so I'm happy to see this action coming from the FDA, FDA Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco. The new rule becomes effective June 22, 2010, and has the force and effect of law.

Here are the highlights:

New Requirements Relating to Sale and Distribution

• Prohibits the sale of cigarettes or smokeless tobacco to people younger than 18.
• Prohibits the sale of cigarette packages with fewer than 20 cigarettes.
• Prohibits the sale of cigarettes and smokeless tobacco in vending machines, self-service displays, or other impersonal modes of sales, except in very limited situations.
• Prohibits free samples of cigarettes and limits distribution of smokeless tobacco products.

New Requirements Relating to Marketing (Labeling, Advertising, and Promotion)

• Prohibits tobacco brand name sponsorship of any athletic, musical, or other social or cultural event, or any team or entry in those events.
• Prohibits gifts or other items in exchange for buying cigarettes or smokeless tobacco products.
• Requires that audio ads use only words with no music or sound effects.
• Prohibits the sale or distribution of items, such as hats and tee shirts, with tobacco brands or logos.

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CA E-Pedigree - Pedigree and Serialization

In Why California (Still) Matters, a podcast interview of Adam Fein offers a quick overview of key issues regarding supply chain security, compliance costs, state versus federal legislation, and data ownership issues. This podcast nicely frames the issues before you dive deeper into the specifics surrounding California's e-Pedigree legislation.

The CA e-Pedigree situation is getting complicated as the state's serialized e-pedigree law implementation deadline is shifting from 2011 to 2015 in order to give folks affected by the law some additional time to implement electronic technology to track the distribution of drugs within the state.

Additional Resources:

1. CA State Board of Pharmacy - California E-Pedigree Law
2. CA E-Pedigree: Hasta La Vista, 2011 - a blog post by Fein

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