(1) All persons and firms, except persons exempt from registration, must register with the commission in order to legally possess or use controlled substances.
(2) Persons or firms which are not classified as pharmacies, wholesalers, manufacturers, or researchers will be classified as other controlled substance registrants. Examples of persons or firms in this classification include analytical laboratories, dog handlers/trainers who use dogs for drug detection purposes, school laboratories, opioid treatment programs (OTP), and other agencies which have a legitimate need to use precursor chemicals as defined in WAC 246-945-053.
(3) For the purposes of this section:
(a) "Mobile unit" means a component of an opioid treatment program that the DEA has approved to operate as a mobile narcotic treatment program pursuant to 21 C.F.R. § 1301.13.
(b) "Opioid treatment program(s)" or "OTP(s)" means a behavioral health agency that has been licensed by the department and certified as an opioid treatment program.
(4) The applicant for a controlled substance registration must complete and return an application form supplied by the commission. A list of the controlled substances to be used, the purpose for such use, and the names of the persons authorized to access the controlled substances must be listed on the application or on an addendum. An applicant for a controlled substance registration who is an OTP must also identify any mobile units operated by the agency, if any, in the application or in an addendum.
(5) An other controlled substance registrant shall:
(a) Ensure all controlled substances are stored in a substantially constructed locked cabinet to prevent unauthorized access;
(b) Maintain records in sufficient detail in order to account for the receipt, use, and disposition of all controlled substances;
(c) Inventory all controlled substances in the possession of the registrant every two years on the anniversary of the issuance of the registration and shall maintain the inventory for two years;
(d) Return unwanted, outdated, or unusable controlled substances to the source from which it was obtained, surrendered to the DEA, or as otherwise permitted by state and federal law; and
(e) Affix a label to every box, bottle, jar, tube, or other container that is dispensed and delivered to an ultimate user that meets the labeling requirements in RCW 69.41.050.
(6) Other controlled substance registrants that are OTPs, who have notified the department that they will be operating a mobile unit must:
(a) Notify the local DEA office and receive explicit written approval from the local DEA office prior to operating the mobile opioid treatment program unit;
(b) Possess valid county/city and Washington state vehicle licensing and registration prior to transporting controlled substances;
(c) Not reverse distribute, share, or transfer controlled substances from one mobile component to another mobile component while deployed away from the registered location;
(d) Establish policies and procedures to ensure, if the mobile unit becomes inoperable, that all controlled substances on the inoperable mobile unit are accounted for, removed, and secured at the registered location of the OTP;
(e) Return to the registered location at the completion of each operation and remove all controlled substances to secure within the registered location; and
(f) Notify the commission of any changes to the information provided on the application, including the addition or removal of a mobile unit.
[Statutory Authority: RCW 18.64.005 and 69.50.302. WSR 26-17-010, s 246-945-060, filed 8/6/26, effective 9/6/26. Statutory Authority: RCW 18.64.005, 18.64.080, 18.130.075, 18.64.043, 18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310, 18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253, 18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-060, filed 6/1/20, effective 7/1/20.]