PROFESSIONS, VOCATIONS, AND BUSINESSES
54-1729A. WHOLESALE DRUG DISTRIBUTOR — LICENSURE. (1) In addition to meeting federal requirements, every business entity that engages in the wholesale distribution of prescription drugs in or into Idaho must be licensed by the board as a wholesale distributor except:
(a) Manufacturers distributing their own federal food and drug administration-approved drugs and devices, including distribution of prescription drug samples by manufacturers’ representatives and intracompany sales, meaning any transaction or transfer between any division, subsidiary, parent, or affiliated or related company under common ownership and control of a corporate entity or any transfer between colicensees of a colicensed product, unless particular requirements are deemed necessary and appropriate following rulemaking;
(b) An entity that donates prescription drugs, when conducted in accordance with sections 54-1760 through 54-1765, Idaho Code;
(c) A pharmacy distributing in accordance with section 54-1732, Idaho Code; and
(d) Persons selling, purchasing, distributing, trading, or transferring a prescription drug for emergency medical reasons.
(2) The board shall not issue a wholesale distributor license to an applicant unless the board determines that the designated representative meets the following qualifications:
(a) Is actively involved in and aware of the actual daily operation of the wholesale distributor; and
(b) Is physically present at the facility of the applicant during regular business hours, except when the absence of the designated representative is authorized, including but not limited to sick leave and vacation leave.
(3) All applicant-designated representatives shall submit to a fingerprint-based criminal history check of the Idaho central criminal history database and the federal bureau of investigation criminal history database. Each applicant shall submit a completed ten (10) finger fingerprint card or scan to the board of pharmacy at the time of application and shall pay the cost of the criminal history check.
(4) A wholesale distributor shall have adequate processes in place for monitoring purchase activity of customers and identifying suspicious ordering patterns that indicate potential diversion or criminal activity related to controlled substances such as orders of unusual size, orders deviating substantially from a normal pattern, orders for drugs that are outside of the prescriber’s scope of practice, or orders of unusual frequency.
(5) The board may adopt rules to approve an accreditation body to evaluate a wholesaler’s operations to determine compliance with professional standards and any other applicable laws and to perform inspections of each facility and location where wholesale distribution operations are conducted by the wholesaler.
[54-1729A, added 2021, ch. 54, sec. 19, p. 175.]