FDA Compliance Manual For Dietary Supplements

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Updated May 7, 2021

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FOOD AND DRUG ADMINISTRATION - COMPLIANCE PROGRAM GUIDANCE MANUAL - CHAPTER 21 – FOOD COMPOSITION, STANDARDS, LABELING, AND ECONOMICS - DIETARY SUPPLEMENTS – FOREIGN AND DOMESTIC INSPECTIONS, SAMPLING, AND IMPORTS (IMPLEMENTATION DATE: 09/30/2020) - PDF | FDA.gov 

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The FDA recently made the following available online, Dietary Supplements, Import and Domestic - Ch 21 Food Composition, Standards, Labeling, and Economics - Food and Drug Administration (FDA) - Compliance Program Guidance Manual.

It's a great reference that should be reviewed by everybody in the dietary supplement sector. Of note:

1. Part III - Inspectional - a wonderful listing of things to pay attention to, in almost checklist fashion
2. Part V-A - GMP Violations - watch out! Don't commit any of these major deviations:

• Lack of master manufacturing records or significant requirements not included
• Lack of finished product release criteria or failure to test (all or subset of finished batches) or meet finished product release criteria critical to product safety and quality
• For significant dietary ingredients, e.g. those that make up the bulk of the product, failure to establish specifications for incoming material or failure to conduct identity testing
• No quality control review procedures or significant quality control procedures not implemented
• No batch records
• Significant physical plant deficiencies.

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IFPMA Launches 10 Principles On Counterfeit Medicines

The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) hopes the The IFPMA Ten Principles on Counterfeit Medicines will highlight the full scope of the problem and demonstrate that the fight against counterfeit medicines is simply about protecting patients’ health.

In a nutshell, here are the 10 principles:

1. Medicine counterfeiting is first and foremost a crime against patients
2. Counterfeit medicines threaten the full spectrum of legitimate medicines.
3. Patents have nothing to do with counterfeiting and counterfeiting has nothing to do with patents.
4. All substandards are not counterfeits.
5. A medicine that is authorized for marketing by one regulatory authority but not by another should not be regarded as counterfeit.
6. Government regulatory and enforcement authorities must be fully vested with the proper power and adequately resourced to fight counterfeits.
7. Stopping the international trade in counterfeit medicines is vital.
8. All stakeholders across the pharmaceutical supply chain must be made aware of the health threats posed by counterfeit medicines and collaborate.
9. Global cooperation is needed
10. The leadership of the World Health Organization (WHO) is crucial.

More Information:
IFPMA launches Ten Principles on Counterfeit Medicines - News Release

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FDA Issues Dietary Supplement Warning Letter

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Updated August 15, 2016

You might also be interested in this FDA guidance document:
Dietary Supplements: New Dietary Ingredient Notifications and Related Issues: Guidance for Industry - Draft Guidance (PDF)

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Here we go folks. It appears we're going to start seeing action by the FDA in the Dietary Supplements sector.

This FDA Law Blog post reports the issuance of an FDA warning letter, FDA Posts its First Dietary Supplement GMP Warning Letter.  A nice read.

If you want to see what else is going on, go to the FDA's Electronic Reading Room - Warning Letters - Browse Warning Letters By Subject - the letter D - scroll down to the Dietary Supplement selections.

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FDA Orders Baxter Colleague Infusion Pump Recall and Destruction

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Checkout this post on the Designated Representative and Exemptee Blog, FDA Orders Recall and Destruction of Baxter Colleague Infusion Pumps.

It turns out after multiple attempts by Baxter to fix many pump problems, the FDA has had to come down hard by ordering the recall and destruction of the Colleague infusion pump.

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FDA Wants Companies To Prevent Cargo Theft

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The FDA is committed to protecting consumers from the threat of stolen, counterfeit, and diverted FDA-regulated products such as prescription or over-the-counter medicines, medical devices, or infant formula.

The U.S. Food and Drug Administration sent a letter (FDA urges industry to prevent cargo thefts - UPI.com),  to companies and a wide range of other key stakeholders detailing the agency’s concern over cargo and warehouse thefts of FDA-regulated products.  In its letter, the FDA seeks to:

1. raise awareness among industry about each firm’s responsibility to review and strengthen their security practices
2. inform industry of the actions the FDA will take when the agency becomes aware of a large-scale theft, and outlines steps that firms should take
3. emphasize the importance of notifying and informing members of the supply chain and the public after thefts occur.

The FDA believes every company should have a clear plan developed on how to respond to these incidents, since swift action is essential. The agency believes prevention of cargo theft is critical. To help achieve that goal, the FDA will continue to work closely with manufacturers and wholesalers to find ways to better secure the nation’s supply chain, which protects the public health.

Additional FDA Resources:
The FDA Cargo Thefts Webpage - FDA created this webpage to provide timely notice to the public about cargo thefts involving FDA-regulated products that have been stolen either from warehouses or tractor-trailers.

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