The COVID Project
Context, not an orderThis record is guidance or an announcement kept for context. It is not counted among the orders in force.
The record
- Jurisdiction
- United States (federal); Food and Drug Administration, Center for Drug Evaluation and Research
- Level
- Federal
- Authority
- FD&C Act ss. 501(a)(2)(B), 502(f)(1), 505, 582; enforcement discretion
- Issued
- 2020-03-19 Mar. 19, 2020
- Effective
- 2020-03-19 (immediately in effect) (read as 2020-03-19)
- End
- 2021-12-31 (FDA withdrawal announced Oct. 12, 2021; products made under the policy to be sold out by Mar. 31, 2022) (read as 2021-12-31)
- In force
- Mar. 19, 2020 to Dec. 31, 2021
- Quarters
- 2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3
2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3
- Limitation types
- Supply chainOther
- Addressees
- firms preparing hand sanitizer (pharmacies, compounders, distillers, manufacturers)
- Functions reached
- PF production floor (converted lines)
- SC supply chain
- RT retail products
- Character
- context
- Collection
- Other federal health agencies AGY-FED-HEALTH-OTHER
Operative words
Because of the public health emergency posed by COVID-19, FDA does not intend to take action against firms that prepare alcohol-based hand sanitizers for consumer use and for use as health care personnel hand rubs for the duration of the public health emergency declared by the Secretary of HHS on January 31, 2020, provided the following circumstances are present
Enforcement
Enforcement discretion under 21 U.S.C. 331 for violations of the listed sections
Notes
Reached distilleries, breweries, cosmetics and chemical manufacturers that converted production; a compelled-substitute predicate for employers' sanitation supply under State orders.
Retrieval noteMarch 20, 2020 archived version. Cite it as context and cite the underlying order, statute or emergency rule it describes as the instrument. (Bulletins whose operative text imposes a mandatory duty on licensees under the regulator's own authority are excluded from this downgrade and listed separately for review.)).