{"id":"SEC-26-001","kind":"order","level":"federal","jurisdiction":"United States (FDA Center for Veterinary Medicine)","state":"","metro":"","industry":"26","agency":"","eco":"","issuer":"Food and Drug Administration, Center for Veterinary Medicine","authority":"21 U.S.C. § 371(h) (FD\u0026C 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","instrument":"Guidance for Industry #269, Enforcement Policy Regarding Federal VCPR Requirements to Facilitate Veterinary Telemedicine During the COVID-19 Outbreak (Docket FDA-2020-D-1140)","title":"Enforcement Policy Regarding Federal VCPR Requirements to Facilitate Veterinary Telemedicine During the COVID-19 Outbreak: Guidance for Industry","dateIssued":"2020-03-24","effective":"2020-03-24 (implemented immediately without prior public comment)","end":"2023-02-21 (withdrawal date fixed by 87 Fed. Reg. 78111, Dec. 21, 2022; Ex. SEC-26-002)","startDate":"2020-03-24","endDate":"2023-02-21","quarters":["2020Q2","2020Q3","2020Q4","2021Q1","2021Q2","2021Q3"],"types":["HC","OTHER"],"addressees":["veterinarians","animal drug and feed sponsors","State veterinary boards (acknowledged)"],"clause":"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\u0027 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, \u0027Contains Nonbinding Recommendations\u0027); the underlying rules 21 C.F.R. part 530 and § 558.6 remained in force","functions":["CL clinical services by telemedicine (compelled substitute)","RT pharmacy (extralabel and VFD prescribing)","CB clients confined by stay-home orders"],"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\u0027s consolidated notice of availability, 85 Fed. Reg. 28010 (Ex. SEC-26-005).","sourceUrl":"https://downloads.regulations.gov/FDA-2020-D-1140-0001/attachment_1.pdf","snapshot":"","fileExists":true,"fileBytes":119322,"grade":"primary","character":"","description":"","collection":"SEC-26","url":"/library/SEC-26-001","exhibitUrl":"/exhibit/SEC-26-001","citation":"Food and Drug Administration, Center for Veterinary Medicine, Guidance for Industry #269, Enforcement Policy Regarding Federal VCPR Requirements to Facilitate Veterinary Telemedicine During the COVID-19 Outbreak (Docket FDA-2020-D-1140) (Mar. 24, 2020) (Ex. SEC-26-001)","stateName":"","related":["SEC-26-002","SEC-26-005"]}