Sec. 5. National licensure standards for third-party logistics providers
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/bill/113/hr/1919/eh/section-5A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Subchapter H of chapter V of the Federal Food, Drug, and Cosmetic Act, as amended by section 4, is further amended by adding at the end the following: No facility may engage in the activities of a third-party logistics provider in any State unless— the facility is licensed— by the State from which the drug is distributed by the third-party logistics provider in accordance with a qualified licensing program, if the State has such a program; or by the Secretary under this section, if the State from which the drug is distributed does not have such a program; and if the drug is distributed interstate and the facility is not licensed by the Secretary under paragraph (1)(B), registers with the State into which the drug is distributed if such State requires such registration.
Beginning not later than 1 year after the date of the enactment of this section, each facility engaged in the activities of a third-party logistics provider shall submit on an annual basis, and update as necessary, a report to the Secretary including— the facility’s name; the facility’s address; a listing of each jurisdiction (whether State or Federal) in which the facility is licensed for third-party logistics provider activities; and any disciplinary actions taken by a State or Federal licensing authority during the reporting period against the facility.
The Secretary shall post on the public Internet Website of the Food and Drug Administration the name of each third-party logistics provider, and each jurisdiction (whether State or Federal) in which the provider is licensed, based on reports under paragraph (1). This subchapter does not prohibit a State from— licensing third-party logistic providers for the conduct of third-party logistics provider activities in the State in accordance with this subchapter; and collecting fees from third-party logistics providers in connection with such licensing, so long as the State does not require such licensure to the extent to which an entity is engaged in wholesale distribution.
In the case of a facility engaging in the activities of a third-party logistics provider licensed by the Secretary under this section, the Secretary may assess and collect a reasonable fee in an amount equal to the costs to the Federal Government of establishing and administering the licensure program established, and conducting period inspections, under this section. The Secretary shall adjust the amount of the fee under paragraph
(1)on an annual basis, if necessary, to generate an amount of revenue equal to the costs referred to in such paragraph. Fees assessed and collected under this subsection shall be available for obligation only to the extent and in the amount provided in advance in appropriations Acts. Such fees shall remain available until expended. The Secretary shall establish, by regulation, standards, terms, and conditions for licensing persons to engage in third-party logistics provider activities. The regulations under paragraph
(1)shall— include standards relating to eligibility for, and revocation and reissuance of, licenses; establish a process by which the applicable licensing authority will, upon request by a third-party logistics provider that is accredited by a third-party accreditation program approved by the Secretary, issue a license to the provider; establish a process by which the Secretary shall issue a license to a third-party logistics provider if the Secretary is not able to approve a third-party accreditation program because no such program meets the Secretary’s requirements necessary for approval of such a third-party accreditation program; require that the third-party logistics provider comply with storage practices, as determined by the Secretary, at the provider’s facilities, including— maintaining access to warehouse space of suitable size to facilitate safe operations, including a suitable area to quarantine suspect prescription drug product; maintaining adequate security; and having written policies and procedures to— address receipt, security, storage, inventory, shipment, and distribution of a prescription drug product; identify, record, and report confirmed losses or thefts in the United States; correct errors and inaccuracies in inventories; provide support for manufacturer recalls; prepare for, protect against, and address any reasonably foreseeable crisis that affects security or operation at the facility, such as a strike, fire, or flood; ensure that any expired prescription drug product is segregated from other prescription drug products and returned to the manufacturer or repackager or destroyed; maintain the capability to electronically trace the receipt and outbound distribution of a prescription drug product, and supplies and records of inventory; and quarantine or destroy a suspect prescription drug product if directed to do so by the respective manufacturer, wholesale distributor, dispenser, or an authorized government agency; provide for periodic inspection, as determined by the Secretary, of such facility warehouse space to ensure compliance with this section; prohibit a facility from having as a manager or designated representative anyone convicted of any felony violation of section 301(i) or 301(k) or any felony violation of section 1365 of title 18, United States Code, relating to prescription drug product tampering; perform mandatory background checks of the provider’s facility managers or designated representatives of such managers; require a third-party logistics provider to provide to the applicable licensing authority, upon the authority’s request, a list of all prescription drug product manufacturers, wholesale distributors, and dispensers for whom the third-party logistics provider provides services at the provider’s facilities; and include procedures under which any third-party logistics provider license— will expire on the date that is 3 years after issuance of the license; and may be renewed for additional 3-year periods. A license issued under this section shall remain valid as long as such third-party logistics provider remains accredited by the Secretary, subject to renewal under subsection (d). If the Secretary finds that the third-party accreditation program demonstrates that all applicable requirements for licensure under this section are met, the Secretary shall issue a license under this section to a third-party logistics provider receiving accreditation. In this section, the term qualified licensing program means a program meeting the requirements of this section and the regulations thereunder. The requirements of this section shall take effect not later than 1 year after the date of the enactment of this section. The Secretary shall issue the regulations required by subsection
(d)not later than 180 days after the date of the enactment of this section. .