The COVID Project
The record
- Jurisdiction
- United States (federal); Drug Enforcement Administration, Diversion Control Division
- Level
- Federal
- Authority
- 21 C.F.R. 1307.03; exception to 21 C.F.R. 1307.11(a)(1)(iv) (five percent rule)
- Issued
- 2020-04-13 Apr. 13, 2020
- Effective
- 2020-04-13
- End
- For the duration of the public health emergency (read as 2021-09-30)
- In force
- Apr. 13, 2020 to Sept. 30, 2021
- Quarters
- 2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3
2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3
- Limitation types
- Health care ordersSupply chainOther
- Addressees
- DEA-registered practitioners (including hospitals and pharmacies)
- Functions reached
- SC supply chain (hospital-to-hospital transfers)
- IP inpatient surge
- WH pharmacy inventory
- Collection
- Other federal health agencies AGY-FED-HEALTH-OTHER
Operative words
Under normal circumstances, DEA would not consider issuing a general exception to the five percent rule as it is essential to the diversion control regime of the CSA to generally limit activities involving controlled substances to those authorized by a person's registration.... pursuant to 21 CFR 1307.03, DEA hereby grants the following temporary exception to 21 CFR 1307.11(a)(1)(iv).
Enforcement
Distribution without a distributor registration otherwise unlawful under 21 U.S.C. 841(a) and 842
Notes
Permitted hospitals and pharmacies to redistribute sedatives and other shortage drugs to one another during ICU surges.