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May 8, 2020

CPG Sec. 450.100 CGMP Enforcement Policy – OTC vs Rx Drugs

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5)) If unable to submit comments online, please mail written […]
May 8, 2020

AgroTerra, Ltd. dba Patriot Hemp Company – 606086 – 05/07/2020

Product: Drugs Recipient: Recipient Name Mr. Doug Pineda AgroTerra, Ltd. dba Patriot Hemp Company 209 McConnell Ct.Lyons, CO 80540United States [email protected] Date:               May 7, […]
May 8, 2020

WashingtonsLastFrontier.Com – 606273 – 05/07/2020

Product: Drugs Date:              May 7, 2020 CC:                  [email protected] – Amazon Associates Program RE:                 Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) This […]
May 8, 2020

Chronic Lyme Treatments – 607094 – 05/07/2020

Product: Drugs Date:               May 7, 2020 RE:                  Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) This is to advise you that the […]
May 8, 2020

Sanit Technologies LLC dba Durisan – 606050 – 05/07/2020

Product: Drugs Recipient: Recipient Name Mr. Troy M. Daland Recipient Title CEO Sanit Technologies LLC dba Durisan 7810 25th Court East Unit 106Sarasota, FL 34243-2841United States […]
May 8, 2020

CPG Sec. 420.200 Compendium Revisions and Deletions

Issued by: Guidance Issuing Office Center for Drug Evaluation and Research BACKGROUND: The USP and NF are continually being revised to keep pace with advances in […]
May 8, 2020

CPG Sec. 410.100 *Finished Dosage Form Drug Products in Bulk Containers – Applications of Current Good Manufacturing Practice Regulations*

Issued by: Guidance Issuing Office Center for Drug Evaluation and Research BACKGROUND: *Questions have arisen concerning the application of the “umbrella” CGMP regulations, 21 CFR Parts […]
May 8, 2020

CPG Sec. 400.800 Collection and Charitable Distribution of Drugs

Issued by: Guidance Issuing Office Center for Drug Evaluation and Research BACKGROUND: A significant proportion of the prescription drugs distributed in the United States is in […]
May 8, 2020

CPG Sec. 400.700 Drug Product Entries in Periodic Publications

Issued by: Guidance Issuing Office Center for Drug Evaluation and Research BACKGROUND: On June 3, 1986, an attorney wrote to the Food and Drug Administration (“FDA”) […]
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