The COVID Project
The record
- Jurisdiction
- United States (FDA Center for Veterinary Medicine)
- Level
- Federal
- Authority
- 21 U.S.C. § 371(h) (FD&C Act § 701(h)(1)(C)(i)); 21 C.F.R. § 10.115(g)(2); enforcement discretion as to 21 C.F.R. part 530 and § 558.6
- Issued
- 2020-03-24 Mar. 24, 2020
- Effective
- 2020-03-24 (implemented immediately without prior public comment) (read as 2020-03-24)
- End
- 2023-02-21 (withdrawal date fixed by 87 Fed. Reg. 78111, Dec. 21, 2022; Ex. SEC-26-002) (read as 2023-02-21)
- In force
- Mar. 24, 2020 to Feb. 21, 2023
- Quarters
- 2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3
2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3
- Limitation types
- Health care ordersOther
- Addressees
- veterinarians
- animal drug and feed sponsors
- State veterinary boards (acknowledged)
- Functions reached
- CL clinical services by telemedicine (compelled substitute)
- RT pharmacy (extralabel and VFD prescribing)
- CB clients confined by stay-home orders
- Collection
- Veterinary and Animal Services SEC-26
Operative words
FDA is aware that during the COVID-19 outbreak some States are modifying their requirements for veterinary telemedicine, including State requirements regarding the veterinarian-client-patient relationship (VCPR). Given that the Federal VCPR definition requires animal examination and/or medically appropriate and timely visits to the premises where the animal(s) are kept, the Federal VCPR definition cannot be met solely through telemedicine. To further facilitate veterinarians' ability to utilize telemedicine to address animal health needs during the COVID-19 outbreak, FDA intends to temporarily suspend enforcement of a portion of the Federal VCPR requirements. Specifically, FDA generally intends not to enforce the animal examination and premises visit VCPR requirements relevant to FDA regulations governing Extralabel Drug Use in Animals (21 CFR part 530) and Veterinary Feed Directive Drugs (21 CFR 558.6).
Enforcement
Enforcement discretion (guidance, 'Contains Nonbinding Recommendations'); the underlying rules 21 C.F.R. part 530 and § 558.6 remained in force
Notes
The federal instrument that made telemedicine lawful for prescribing when the State orders closed waiting rooms and suspended elective visits; cited as guidance (T2 framing: the State orders are the force-of-law layer; this is the federal accommodation to them). Listed as issued March 2020 in FDA's consolidated notice of availability, 85 Fed. Reg. 28010 (Ex. SEC-26-005).
Retrieval noteThe former fda.gov/media/136505/download URL now serves an unrelated image (live and in the 2021 Wayback capture); the guidance was retrieved from the regulations.gov docket, document FDA-2020-D-1140-0001 (posted Mar. 24, 2020), and read in full.