(1)In addition to meeting federal requirements, every business entity that engages in the wholesale distribution of prescription drugs, durable medical equipment, or pseudoephedrine products in or into Idaho shall 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;
(b)An entity that donates prescription drugs, when conducted in accordance wit
Free access — add to your briefcase to read the full text and ask questions with AI
(1) In addition to meeting federal requirements, every business entity that engages in the wholesale distribution of prescription drugs, durable medical equipment, or pseudoephedrine products in or into Idaho shall 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;
(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;
(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; and
(c) Has disclosed under oath any felony convictions, any conviction of the applicant related to wholesale or retail prescription drug distribution, or any discipline by a state regulatory agency related to wholesale or retail prescription drug distribution.
(3) All applicant-designated representatives shall submit to a fingerprint-based criminal history check in accordance with section 67-9411A, Idaho Code.
(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 shall recognize a wholesaler’s accreditation by the national association of boards of pharmacy for purposes of reciprocity and satisfying the new drug outlet inspection required by this chapter.