Sec. 301. Grandfathering of State medical cannabis products into interstate commerce

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Subchapter V of chapter 9 of title 21 of the United States Code (the Federal Food, Drug, and Cosmetic Act) is amended by adding at the end the following new part: Sec. 360ggg. Definitions. Sec. 360ggg–1. Regulation of medical cannabis products. Sec. 360ggg–2. Cannabis-infused foods, beverages, and supplements. Sec. 360ggg–3. Cannabis cosmetics. Sec. 360ggg–4. Liability and method of payment. Sec. 360ggg–5. Private right of action and administrative remedy. In this part: The term designated State medical cannabis product — means an article that is produced by a State and federally licensed or permitted medical cannabis business, pursuant to a State medical cannabis program and contains marihuana , as defined in section 102(16) of the Controlled Substances Act; means any other article that contains either marihuana , as defined in section 102 of the Controlled Substances Act, 21 U.S.C. 802 , deemed appropriate by the Secretary, after taking into account any investigational new drug application or investigational new animal drug application for the same medical cannabis product submitted in accordance with regulations applicable to such applications in title 21 of the Code of Federal Regulations, unless any period of exclusivity for a new drug under section 355(c)(3)(E)(ii) of this title or section 355(j)(5)(F)(ii) of this title, or the extension of any such period under section 355a of this title, or any period of exclusivity for a new animal drug under section 360b(c)(2)(F) of this title, applicable to such medical cannabis product has not expired; means any article that contains either marihuana , as defined in section 102(16) of the Controlled Substances Act, 21 U.S.C. 802(16) that also meets the standards set forth in an official compendium; and does not mean articles or cannabis products produced and intended for nonmedical use, such as those regulated under title III of the Federal Alcohol Administration Act ( 27 U.S.C. 201 et seq. ).

The term State includes the District of Columbia, Puerto Rico, and any commonwealth, territory, enclave, Indian tribe, or possession of the United States. The Food and Drug Administration shall have jurisdiction over the regulation of designated State medical cannabis products described herein. Beginning 30 days after the effective date of this Act, any person who seeks to initially introduce or deliver for introduction a designated State medical cannabis product into interstate commerce may file with the Secretary a request for certification as a designated State medical cannabis product.

Any such request shall contain the following information: A description of the designated State medical cannabis product. The name and address of the sponsor. The name and address of the facility or facilities where the designated State medical cannabis product is or will be cultivated and manufactured. Any other information deemed appropriate by the Secretary to determine whether the designated State medical cannabis product is in fact a designated State medical cannabis product.

The certification requested under paragraph

(1)is deemed to be granted unless, within 30 days of the filing of such request, the Secretary finds that— the designated State medical cannabis product subject to the certification is not in fact a designated State medical cannabis product; the request does not contain the information required under paragraph

(1)or otherwise lacks sufficient information to permit the Secretary to determine that the designated State medical cannabis product is in fact a designated State medical cannabis product; or denying the request is necessary to protect the public health. A designated State medical cannabis product for which a certification is granted under paragraph

(2)is deemed, alone or in combination, as medically appropriate, with another designated State medical cannabis product or products for which a certification or certifications have been granted, to be sold in interstate commerce as a non-drug designated State medical cannabis product, for the following indications for use: The treatment of arthritis. The treatment of chemotherapy-induced and non-chemotherapy-induced nausea and vomiting. The stimulation of appetite. The treatment of the symptoms of patients with HIV/AIDS or for anorexia associated with AIDS. The treatment of temporary or chronic pain and analgesia. The treatment of muscle spasms. The treatment of insomnia and restlessness. The treatment of post-traumatic stress disorder. The treatment of chronic pain due to sickle cell disease. Any other indication for use consistent with State medical cannabis law and medical cannabis labeling practice in the State in which the product is to be sold to the end consumer. Any other indication for use for a designated State medical cannabis product or combination of designated State medical cannabis products deemed appropriate by the Secretary, unless any period of exclusivity for a new drug under clause

(iii)or

(iv)of section 355(c)(3)(E) of this title, clause

(iii)or

(iv)of section 355(j)(5)(F) of this title, or section 360cc of this title, or the extension of any such period under section 355a of this title, applicable to such indication for use for such medical cannabis product or combination of products has not expired. The requirements of sections 353(b)(4) and 352(f) of this title are deemed to have been met for a designated State medical cannabis product if the labeling on the final use container for such medical cannabis product bears— the information required by section 353(b)(4) of this title; a warning statement concerning the use of the medical cannabis products as determined by the Secretary by regulation; and appropriate directions and warnings concerning storage and handling. No exclusivity for a certified medical cannabis product. No designated State medical cannabis product deemed under subparagraph (A)(i) to have in effect an approved application is eligible for any period of exclusivity for a new drug under section 355(c), 355(j), or 360cc of this title, or the extension of any such period under section 355a of this title, on the basis of such deemed approval. No period of exclusivity under section 355(c), 355(j), or section 360cc of this title, or the extension of any such period under section 355a of this title, with respect to an application for a drug product, shall prohibit, limit, or otherwise affect the submission, grant, or effect of a certification under this section, except as provided in subsection (a)(3)(A)(i)(VIII) and section 360ddd(1)(H) of this title. Nothing in this part limits the Secretary’s authority to withdraw or suspend approval of a drug product, including a designated State medical cannabis product deemed under this section to have in effect an approved application under section 355 of this title or section 360b of this title. The Secretary may revoke the grant of a certification under paragraph

(2)if the Secretary determines that the request for certification contains any material omission or falsification. A designated State medical cannabis product is not approved for use without a prescription by a qualified medical professional or a recommendation by a qualified medical professional as defined by the law of the State in which the qualified medical professional is providing said prescription or recommendation. For medical cannabis products provided pursuant to subparagraph (A), the Secretary shall issue labeling requirements within 90 days of the passage of this Act. Notwithstanding any other law, 21 U.S.C. 331(ll) , the drug preclusion rule, shall not apply to marihuana , as defined in 21 U.S.C. 802(16) . Notwithstanding any other Federal law or provision of the Federal Food, Drug, and Cosmetic Act, the Food and Drug Administration shall treat cannabis without respect to the doctrine of drug preclusion. Nothing in this provision is meant to diminish or otherwise affect the ability of the Food and Drug Administration to regulate drug products (as defined in 21 U.S.C. 321(g) ), including those containing marihuana , (as defined in 21 U.S.C. 802(16) ) that are intended and marketed for use as a drug rather than a designated State medical cannabis product . Within 30 days of the passage of this Act, the Food and Drug Administration shall promulgate an interim final rule and undertake rulemaking under the Administrative Procedure Act ( 5 U.S.C. 500 et seq. ) for the purposes of effectuating this provision, including any forms that may be required for application for certification. Such final rule shall be promulgated within 90 days of the publication of the interim final rule. Notwithstanding any other law, 21 U.S.C. 321(s)(6) shall not apply to marihuana , as defined in 21 U.S.C. 802(16) , nor to industrial hemp , as defined in 7 U.S.C. 5490(a)(2) . Notwithstanding any other Federal law or provision of the Federal Food, Drug, and Cosmetic Act, the Food and Drug Administration shall treat cannabis without respect to the doctrine of dietary supplement and food additive preclusion. Notwithstanding any other law, marihuana , as defined in 21 U.S.C. 802(16) , and industrial hemp , as defined in 7 U.S.C. 5490(a)(2) , shall be deemed to have been marketed in the United States as a dietary ingredient before October 15, 1994 for the purposes of 21 U.S.C. 350b(a) , 350b(d). Within 30 days of the passage of this Act, the Food and Drug Administration shall promulgate an interim final rule and undertake rulemaking under the Administrative Procedure Act ( 5 U.S.C. 500 et seq. ) for the purposes of establishing a standard serving size and further clarifying intended conditions of use of whole-plant cannabis extracts and individual cannabinoid extracts used as dietary supplements. Such final rule shall be promulgated within 90 days of the publication of the interim final rule. Notwithstanding any other law, marihuana , as defined in 21 U.S.C. 802(16) , or industrial hemp , as defined in 7 U.S.C. 5490(a)(2) , shall be deemed to be generally recognized as safe through experience based on common use in food prior to January 1, 1958, for the purposes of 21 U.S.C. 321(s) and 21 CFR 170.30(a). Cannabis-infused foods and beverages, unless a designated State medical cannabis product, shall be considered as regulated under title III of the Federal Alcohol Administration Act ( 27 U.S.C. 201 et seq. ). Within 30 days of the passage of this Act, the Food and Drug Administration shall promulgate an interim final rule and undertake rulemaking under the Administrative Procedure Act ( 5 U.S.C. 500 et seq. ) for the purposes of establishing a standard serving size and further clarifying conditions of intended use of whole-plant cannabis extracts and individual cannabinoid extracts used as food additives. Such final rule shall be promulgated within 90 days of the publication of the interim final rule. safe The use of marihuana , as defined in 21 U.S.C. 802(16) , and industrial hemp , as defined in 7 U.S.C. 5490(a)(2) , alone in cosmetic products shall not cause a cosmetic to be adulterated within the meaning of 21 U.S.C. 361(a) –(e) provided that it is properly labeled and branded within the meaning of title 21, chapter 6 of the United States Code generally. Within 30 days of the passage of this Act, the Food and Drug Administration shall promulgate an interim final rule and undertake rulemaking under the Administrative Procedure Act ( 5 U.S.C. 500 et seq. ) to effectuate this provision. Such final rule shall be promulgated within 90 days of the publication of the interim final rule. Notwithstanding section 360ggg–3(a) of this title, any cosmetic containing marihuana , as defined in 21 U.S.C. 802(16) , and industrial hemp , as defined in 7 U.S.C. 5490(a)(2) , including any extract thereof, where the cannabis component actually renders it a poisonous or deleterious substance, injurious to users under the conditions of use prescribed in the labeling thereof, or under such conditions of use as are customary or usual, may be considered adulterated within the meaning of 21 U.S.C. 361 and/or misbranded under 21 U.S.C. 362 . A designated State medical cannabis product, alone or in combination with another designated State medical cannabis product or products (as medically appropriate) deemed under section 360ggg–1 of this title to have in effect an approved application shall not be assessed fees under section 379h(a) or 379j–12(a) of this title on the basis of such deemed approval. An adversely affected person or business shall have private right of action under the Administrative Procedure Act ( 5 U.S.C. 500 et seq. ) and the Mandamus Act ( 28 U.S.C. 1361 ) to compel the Administrator or any other officer, employee or agent of the Food and Drug Administration to promulgate regulations or undertake and finalize rulemaking required under this Act that are not promulgated or published within the time frames set forth herein, or to provide the certification of designated State medical cannabis products within the time frames set forth herein, or to enjoin agency action. The exclusive venue for bringing any such action shall be the District Court for the District of Columbia. Upon demonstration of undue delay or failure to adhere strictly to statutory deadlines, or other violations of law and equity, equitable relief in the form of a writ of mandamus compelling action shall issue, among such other relief as the court may see fit. .

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