| 02/16/2021 | 02/11/2021 | AcelRx Pharmaceuticals, Inc. | The Office of Prescription Drug Promotion (OPDP) | False & Misleading Claims/Misbranded |
Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Tuesday, February 16, 2021
| 02/16/2021 | 02/11/2021 | Evolved Ayurvedic Discoveries, Inc./BioCBDPlus | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated |
| 02/16/2021 | 11/24/2020 | Vibrant Enterprise LLC | Division of Northeast Imports | Foreign Supplier Verification Program (FSVP) | ||
| 02/16/2021 | 02/03/2021 | My Habitat Brands LLC | Division of Northeast Imports | Foreign Supplier Verification Program (FSVP) | ||
| 02/16/2021 | 02/03/2021 | JR & Son World Trading LLC | Division of Northeast Imports | Foreign Supplier Verification Program (FSVP) |
- As part of the FDA’s effort to protect consumers, the agency issued a warning letter to Evolved Ayurvedic Discoveries, Inc./BioCBDPlus for selling unapproved products, including unapproved products with fraudulent COVID-19 claims. The company sells cannabidiol (CBD) products, including “BioCBD+ Total Body Care,” “BioCBD+ Topical Oil Muscle & Joint Support,” and “BioCBD+ Peace Vape,” and misleadingly represents the products can mitigate, prevent, treat, diagnose or cure COVID-19 in people. Consumers concerned about COVID-19 should consult with their health care provider.
Friday, February 12, 2021
Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency FEBRUARY 2021 Final
Final
- Docket Number:
- FDA-2020-D-1106
- Issued by:
- Center for Drug Evaluation and Research
Updated February 10, 2021
Due to the Coronavirus Disease 2019 (COVID-19) pandemic, the Food and Drug Administration (FDA or Agency) has received a number of queries concerning compounding of alcohol-based hand sanitizers. The Agency is issuing this guidance to communicate its policy for the temporary compounding of certain alcohol-based hand sanitizer products by pharmacists in State-licensed pharmacies or Federal facilities and registered outsourcing facilities (referred to collectively in this guidance as compounders) for the duration of the public health emergency declared by the Secretary of Health and Human Services (HHS) on January 31, 2020.
Submit Comments
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 comments to:
Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852All written comments should be identified with this document's docket number: FDA-2020-D-1106.
Thursday, February 11, 2021
Do These Recent Drug GMP Warning Letters Signal A Shift In FDA Enforcement Focus?
15 hours ago — PCCA is not a total stranger to enforcement actions. The FDA inspection database identifies a 2009 inspection classified as OAI (official a
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