Amended
IN
Assembly
March 23, 2021 |
Introduced by Assembly Member Kamlager (Coauthors: Assembly Members Bloom, Jones-Sawyer, Kalra, Nazarian, Stone, and Ting) (Coauthor: Senator Wiener) |
February 08, 2021 |
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.
(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)
(d)
(e)
(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.