FDA Free Export Guidance
The FDA has provided a formal Guidance on the exporting of products not approved for use in the USA. That Guidance begins:
“This guidance document summarizes and explains the basic requirements and procedures under the FDA Export Reform and Enhancement Act of 1996 (Public Law 104-134, as amended by Public Law 104-180) for exporting human drugs, animal drugs, biological products, devices, food, food additives, color additives, and dietary supplements that may not be sold or distributed in the United States.”
A Review of the Guidance strongly suggests that FDA allows the broadest export authority without prior FDA approval. The Summary Chart provides for export under Section 801(e)(1).
Page 18 of the Guidance sets out the 801 requirements:
“Section 801(e)(1) of the Act states that a food, drug, device, or cosmetic intended for export shall not be deemed to be adulterated or misbranded if the article: • Accords to the specifications of the foreign purchaser; • Is not in conflict with the laws of the country to which it is intended for export; • Is labeled on the outside of the shipping package that it is intended for export; and • Is not sold or offered for sale in domestic commerce.”
Conclusion: A company relying on 801 has to maintain records of the transaction showing compliance with the above provisions and provide the records to the FDA in the event of an inspection. There is no pre-export filing required.
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ERC: EMPLOYEE RETENTION CREDIT
Have you seen the TV ads for this multi-billion dollar program? Get some of your taxes back…
How to Apply for the Employee Retention Credit (ERC) Under the CARES Act
[These 70% Retention Credits are in addition to any PPP loans and are a free grant, no payback. Available to small businesses up to 499 employees.]
1) Watch the 5 minute ERC video with this link:
2) Click on "See If You Qualify" to submit contact info to the Accounting Firm.
3) If qualified and if Company wants to apply, sign the Engagement Letter.
4) If you have further questions, I can set up a call with the Jorns Firm to get questions answered before sign up.
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