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AB-458 Importation of prescription drugs.(2021-2022)

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Date Published: 02/08/2021 09:00 PM
AB458:v99#DOCUMENT


CALIFORNIA LEGISLATURE— 2021–2022 REGULAR SESSION

Assembly Bill
No. 458


Introduced by Assembly Member Kamlager
(Coauthors: Assembly Members Bloom, Jones-Sawyer, Kalra, Stone, and Ting)
(Coauthor: Senator Wiener)

February 08, 2021


An act to add Chapter 11 (commencing with Section 127700) to Part 2 of Division 107 of the Health and Safety Code, relating to prescription drugs.


LEGISLATIVE COUNSEL'S DIGEST


AB 458, as introduced, Kamlager. Importation of prescription drugs.
Existing law establishes the California Health and Human Services Agency (CHHSA), which includes departments charged with the administration of health, social, and other human services. Existing law requires CHHSA to enter into partnerships to increase patient access to affordable drugs and to produce or distribute generic prescription drugs and at least one form of insulin, as specified.
This bill would create the Affordable Prescription Drug Importation Program in CHHSA, under which the state would be a licensed wholesaler that imports prescription drugs, as specified, for the exclusive purpose of dispensing those drugs to state residents with a valid prescription. The bill would require CHHSA to seek federal approval for the importation program on or before June 1, 2022, and would require CHHSA to contract with at least one vendor to provide services under the importation program within 6 months of receiving federal approval. The bill would require a vendor to, among other things, establish a wholesale prescription drug importation list that identifies the prescription drugs that have the highest potential for cost savings to the state and identify and contract with eligible Canadian suppliers who have agreed to export prescription drugs on that list.
This bill would authorize an individual to import a prescription drug only for use by that individual or a member of that individual’s immediate family from a foreign pharmacy if specified requirements are met. The bill would prohibit an individual from, among other things, importing a prescription drug for resale or a controlled substance.
Vote: MAJORITY   Appropriation: NO   Fiscal Committee: YES   Local Program: NO  

The people of the State of California do enact as follows:


SECTION 1.

 The Legislature finds and declares that, in conformity with Section 804 of the federal Food, Drug and Cosmetic Act (21 U.S.C. Sec. 301 et seq.), allowing Californians to import certain prescription drugs from Canada, in the case of wholesale importation, and additional other countries, in the case of personal importation, will not pose additional or unreasonable risks to public health and will result in a significant reduction in the costs of necessary drugs for consumers in California.

SEC. 2.

 Chapter 11 (commencing with Section 127700) is added to Part 2 of Division 107 of the Health and Safety Code, to read:
CHAPTER  11. Affordable Prescription Drug Importation Program

127700.
 For purposes of this chapter:
(a) “Agency” means the California Health and Human Services Agency.
(b) “Foreign pharmacy” means a business licensed in a foreign country to sell prescription drugs at retail and authorized by federal law to import prescription drugs into the United States.
(c) “Importation program” means the Affordable Prescription Drug Importation Program created pursuant to Section 127701.
(d) “Prescription drug” means an outpatient prescription drug self-administered by the patient and approved by the federal Food and Drug Administration for sale to the public, or a foreign version of a self-administered drug approved by the federal Food and Drug Administration. “Prescription drug” does not include a prescription drug administered by a health care practitioner or in a health facility.

127701.
 (a) The Affordable Prescription Drug Importation Program is hereby created in the California Health and Human Services Agency.
(b) Under the importation program, the state shall be a licensed wholesaler that imports prescription drugs from a licensed, regulated foreign supplier, solely for distribution to voluntarily participating, state-licensed, in-state pharmacies and administering providers for the exclusive purpose of dispensing those drugs to state residents with a valid prescription. The importation program shall comply with Section 384 of Title 21 of the United States Code, Part 251 of Title 21 of the Code of Federal Regulations, and other applicable federal rules.
(c) (1) On or before June 1, 2022, the agency shall seek approval of the importation program from the United States Secretary of Health and Human Services.
(2) The agency may expend money upon appropriation by the Legislature for the purpose of requesting approval of the importation program, but shall not expend any other money to implement the importation program until the department receives federal approval of the importation program.
(d) No later than six months after receiving federal approval of the importation program, the agency shall begin operating the importation program. To do so, the agency shall contract with at least one vendor to provide services under the importation program, pursuant to Section 127702.
(e) No later than one year after beginning operation of the importation program, and annually on or before January 1 thereafter, the agency shall submit to the Legislature a report regarding the importation program. The report shall be submitted in compliance with Section 9795 of the Government Code and shall be posted on the agency’s internet website.

127702.
 (a) A vendor, in consultation with the agency and any other contracting vendors, shall establish a wholesale prescription drug importation list that identifies the prescription drugs that have the highest potential for cost savings to the state, including high-cost, low-utilization specialty drugs.
(1) A vendor shall review its wholesale prescription drug importation list at least annually and at the direction of the agency.
(2) The agency shall review a vendor’s wholesale prescription drug importation list at least every three months to ensure the list continues to meet the requirements of the importation program. The agency may direct a vendor to revise its list as necessary.
(b) A vendor shall do all of the following:
(1) Identify, in consultation with the agency, Canadian suppliers who are in full compliance with relevant federal and provincial laws and regulations and who have agreed to export prescription drugs identified on the vendor’s importation list.
(2) Verify that a Canadian supplier meets the requirements of the importation program and shall export prescription drugs at prices that provide cost savings to the state.
(3) Contract with Canadian suppliers eligible pursuant to paragraphs (1) and (2), or facilitate contracts between eligible importers and international suppliers, to import prescription drugs under the importation program.
(4) Assist the agency to develop and administer a distribution program within the importation program.
(5) Assist the agency to prepare its annual report required pursuant to subdivision (e) of Section 127701 and provide requested information to the agency for the annual report.
(6) Ensure the safety and quality of prescription drugs imported under the importation program.
(7) Maintain a list of all eligible importers that participate in the importation program.
(8) Ensure compliance with the federal Drug Quality and Security Act (Public Law 113-54) by all international suppliers, eligible importers, distributors, and other participants in the importation program.
(9) Provide an annual financial audit of its operations to the agency.
(10) Provide to the agency quarterly financial reports specific to the importation program. The reports shall include information concerning the performance of the vendor’s subcontractors and vendors.

127705.
 (a) An individual may import a prescription drug only for use by that individual or a member of that individual’s immediate family from a foreign pharmacy if all of the following requirements are met:
(1) The prescription drug is for personal use.
(2) The prescription drug does not present an unreasonable risk to the user.
(3) The individual is not importing more than a 90-day supply of the prescription drug during a 90-day period.
(4) The user for whom the drug is intended possesses a valid prescription for the imported drug issued by a health care practitioner licensed pursuant to Division 2 (commencing with Section 500) of the Business and Professions Code, and provides that prescription to the foreign pharmacy before the prescription drug is dispensed.
(5) The prescription drug is dispensed by or ordered over the internet from a foreign pharmacy, the export of which does not violate the laws governing the foreign pharmacy.
(b) (1) An individual shall not import a prescription drug if the federal Food and Drug Administration has issued a public notice stating that any of the following are true:
(A) The prescription drug lacks evidence of effectiveness.
(B) The prescription drug is a health fraud drug product.
(C) The prescription drug presents a direct challenge to the federal Food and Drug Administration’s new drug application and over-the-counter monograph processes.
(D) The prescription drug has been reformulated by the manufacturer or exporter to evade an existing federal Food and Drug Administration enforcement action.
(2) An individual shall not import a controlled substance. For purposes of this paragraph, “controlled substance” means a substance listed in Sections 11053 to 11058, inclusive, of this code or Section 812 or 813 of Title 21 of the United States Code.
(3) An individual shall not import a prescription drug for sale or resale.