Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 43 - Third-party Logistics Provider Licenses › Rule 657-43.3 - 3pl License

Current through Register Vol. 47, No. 3, July 24, 2024
Beginning April 1,2019, every 3PL as defined in rule
				657-43.2(155A), wherever located, that provides or coordinates warehousing or
				other logistics services of products into, out of, or within this state must be
				licensed by the board in accordance with the laws and rules of Iowa before
				engaging in such logistics operations. Where activities are conducted at more
				than one location by a single 3PL, each location shall be separately licensed.
				The applicant shall submit a completed application with a nonrefundable
				application fee of $750. A 3PL that handles controlled substances 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 3PL, ownership information, information about the 3PL's
			 registered agent located in Iowa, information about the 3PL's licensure or
			 registration with other state and federal regulatory authorities, criminal and
			 disciplinary history information, and a description of the scope of services to
			 be provided in Iowa. If the applicant is not located in Iowa, the applicant
			 shall submit evidence that the applicant has a valid license or registration in
			 the home state or provide evidence that the home state does not require
			 licensure. The applicant shall provide 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 pursuant to
			 subrule 43.3(3). 3PL distributors located in Iowa shall provide evidence of
			 VAWD accreditation on or before license renewal. An application for a 3PL
			 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).
(2)
Facility manager.
The
			 applicant shall attest that the facility manager has adequate experience in
			 providing or coordinating warehousing or other logistics services of products;
			 is actively involved in the daily operation of the facility; maintains a
			 functional understanding of federal and state laws, rules, and regulations
			 pertaining to drug and device distribution; and has no felony conviction or
			 convictions related to prescription drug or device distribution, including
			 distribution of controlled substances. 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.
(3)
Inspection
			 of new 3PL facility.
Each new 3PL location seeking licensure shall be
			 inspected prior to issuance of a license.
a.
Iowa location.
If the applicant is located within Iowa, an
			 inspection shall be conducted by the board or its authorized agent prior to
			 issuance of the license and periodically thereafter.
b.
Nonresident location.
If
			 the applicant is located outside of Iowa, an inspection shall be conducted by
			 the applicant's home state regulatory authority or another board-approved
			 inspecting authority and a report of such inspection shall be submitted with
			 the application. The application shall also include evidence of corrective
			 action taken to satisfy any deficiencies identified in the inspection report
			 and compliance with all legal directives of the inspecting authority, if
			 applicable. With each license renewal and license reactivation for a 3PL
			 outside of Iowa, the application shall include a copy of the most recent
			 inspection report issued as a result of an inspection conducted by the home
			 state regulatory authority or other board-approved inspecting
			 authority.