Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 17 - Wholesale Distributor Licenses › Rule 657-17.3 - Wholesale Distributor License

Current through Register Vol. 47, No. 3, July 24, 2024
Every wholesale distributor that engages in wholesale
				distribution into, out of, or within this state must be licensed by the board
				before engaging in wholesale distribution. Where operations are conducted at
				more than one location by a single wholesale distributor, each such location
				shall be separately licensed. The applicant shall submit a completed
				application with a nonrefundable application fee of $750. A wholesale
				distributor that engages in wholesale distribution of controlled substances
				into, out of, or within this state shall also obtain a controlled substances
				Act registration pursuant to 657-Chapter 10.
(1)
Application.
The
			 applicant shall complete an application which requires demographic information
			 about the wholesale distributor, ownership information, information about the
			 wholesale distributor's registered agent located in Iowa, information about the
			 wholesale distributor's licensure with other state and federal regulatory
			 authorities, criminal and disciplinary history information, information
			 regarding the facility manager, a detailed description of the services to be
			 provided in this state, and other necessary information as determined by the
			 board. An application for a wholesale distributor license, including an
			 application for registration pursuant to 657-Chapter 10, if applicable, will
			 become null and void if the applicant fails to complete the licensure process,
			 including opening for business, within six months of receipt by the board of
			 the required application(s). The following shall also be submitted by the
			 applicant for the application to be considered complete:
a. Criminal history record check. Upon
			 receipt of a licensure application, the board shall provide a fingerprint
			 packet to the applicant's facility manager, who shall submit the completed
			 fingerprint packet and a signed waiver form to facilitate a national criminal
			 history background check of the facility manager. The cost of the evaluation of
			 the fingerprint packet and the Iowa division of criminal investigation and the
			 United States Federal Bureau of Investigation criminal history background
			 checks will be assessed to the applicant.
b. Surety bond or equivalent security. The
			 applicant shall file with the board a $100,000 surety bond or evidence that the
			 wholesale distributor possesses the required bond in another state where the
			 wholesale distribution facility does business. If a wholesale distributor's
			 annual gross receipts from the previous tax year were $10 million or less, the
			 wholesale distributor need only file a $25,000 surety bond. In lieu of a surety
			 bond, the applicant may submit an irrevocable standby letter of credit in the
			 amount of $100,000 or $25,000 as applicable. A government-owned wholesale
			 distributor is exempt from the surety bond requirement.
c. Evidence of current verified-accredited
			 wholesale distributors (VAWD) accreditation by the National Association of
			 Boards of Pharmacy. This requirement does not apply to new applicants located
			 in Iowa which must undergo an opening inspection by a board compliance officer
			 or agent of the board prior to issuance of an initial license. Wholesale
			 distributors located in Iowa shall provide evidence of VAWD accreditation on or
			 before license renewal.
d.
			 Attestation by facility manager. The applicant shall submit attestation that
			 the facility manager has been employed full-time for at least three years in a
			 position related to prescription drug distribution; is actively involved in the
			 daily operation of the wholesale distribution facility; maintains a functional
			 understanding of federal and state laws, rules, and regulations pertaining to
			 wholesale drug distribution; and has no felony convictions or convictions
			 related to prescription drug distribution, including distribution of controlled
			 substances.