21 U.S.C. § 353 (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter V: DRUGS AND DEVICES / Section 353: Exemptions and consideration for certain drugs, devices, and biological products
Exemptions and consideration for certain drugs, devices, and biological products
Status: in_force

(a) Regulations for goods to be processed, labeled, or repacked elsewhere

The Secretary is directed to promulgate regulations exempting from any labeling or packaging requirement of this chapter drugs and devices which are, in accordance with the practice of the trade, to be processed, labeled, or repacked in substantial quantities at establishments other than those where originally processed or packed, on condition that such drugs and devices are not adulterated or misbranded under the provisions of this chapter upon removal from such processing, labeling, or repacking establishment.

(b) Prescription by physician; exemption from labeling and prescription requirements; misbranded drugs; compliance with narcotic and marihuana laws

(1) A drug intended for use by man which—

(A) because of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, is not safe for use except under the supervision of a practitioner licensed by law to administer such drug; or

(B) is limited by an approved application under section 355 of this title to use under the professional supervision of a practitioner licensed by law to administer such drug;

shall be dispensed only (i) upon a written prescription of a practitioner licensed by law to administer such drug, or (ii) upon an oral prescription of such practitioner which is reduced promptly to writing and filed by the pharmacist, or (iii) by refilling any such written or oral prescription if such refilling is authorized by the prescriber either in the original prescription or by oral order which is reduced promptly to writing and filed by the pharmacist. The act of dispensing a drug contrary to the provisions of this paragraph shall be deemed to be an act which results in the drug being misbranded while held for sale.

(2) Any drug dispensed by filling or refilling a written or oral prescription of a practitioner licensed by law to administer such drug shall be exempt from the requirements of section 352 of this title, except paragraphs (a), (i)(2) and (3), (k), and (l), and the packaging requirements of paragraphs (g), (h), and (p), if the drug bears a label containing the name and address of the dispenser, the serial number and date of the prescription or of its filling, the name of the prescriber, and, if stated in the prescription, the name of the patient, and the directions for use and cautionary statements, if any, contained in such prescription. This exemption shall not apply to any drug dispensed in the course of the conduct of a business of dispensing drugs pursuant to diagnosis by mail, or to a drug dispensed in violation of paragraph (1) of this subsection.

(3) The Secretary may by regulation remove drugs subject to section 355 of this title from the requirements of paragraph (1) of this subsection when such requirements are not necessary for the protection of the public health.

(4)(A) A drug that is subject to paragraph (1) shall be deemed to be misbranded if at any time prior to dispensing the label of the drug fails to bear, at a minimum, the symbol "Rx only".

(B) A drug to which paragraph (1) does not apply shall be deemed to be misbranded if at any time prior to dispensing the label of the drug bears the symbol described in subparagraph (A).

(5) Nothing in this subsection shall be construed to relieve any person from any requirement prescribed by or under authority of law with respect to drugs now included or which may hereafter be included within the classifications stated in sections 4721, 6001, and 6151 of title 26, or to marihuana as defined in section 4761 of title 26.

(c) Sales restrictions

(1) No person may sell, purchase, or trade or offer to sell, purchase, or trade any drug sample. For purposes of this paragraph and subsection (d), the term "drug sample" means a unit of a drug, subject to subsection (b), which is not intended to be sold and is intended to promote the sale of the drug. Nothing in this paragraph shall subject an officer or executive of a drug manufacturer or distributor to criminal liability solely because of a sale, purchase, trade, or offer to sell, purchase, or trade in violation of this paragraph by other employees of the manufacturer or distributor.

(2) No person may sell, purchase, or trade, offer to sell, purchase, or trade, or counterfeit any coupon. For purposes of this paragraph, the term "coupon" means a form which may be redeemed, at no cost or at a reduced cost, for a drug which is prescribed in accordance with subsection (b).

(3)(A) No person may sell, purchase, or trade, or offer to sell, purchase, or trade, any drug—

(i) which is subject to subsection (b), and

(ii)(I) which was purchased by a public or private hospital or other health care entity, or

(II) which was donated or supplied at a reduced price to a charitable organization described in section 501(c)(3) of title 26.

(B) Subparagraph (A) does not apply to—

(i) the purchase or other acquisition by a hospital or other health care entity which is a member of a group purchasing organization of a drug for its own use from the group purchasing organization or from other hospitals or health care entities which are members of such organization,

(ii) the sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug by an organization described in subparagraph (A)(ii)(II) to a nonprofit affiliate of the organization to the extent otherwise permitted by law,

(iii) a sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug among hospitals or other health care entities which are under common control,

(iv) a sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug for emergency medical reasons, or

(v) a sale, purchase, or trade of a drug, an offer to sell, purchase, or trade a drug, or the dispensing of a drug pursuant to a prescription executed in accordance with subsection (b).

For purposes of this paragraph, the term "entity" does not include a wholesale distributor of drugs or a retail pharmacy licensed under State law and the term "emergency medical reasons" includes transfers of a drug between health care entities or from a health care entity to a retail pharmacy undertaken to alleviate temporary shortages of the drug arising from delays in or interruptions of regular distribution schedules.

(d) Distribution of drug samples

(1) Except as provided in paragraphs (2) and (3), no person may distribute any drug sample. For purposes of this subsection, the term "distribute" does not include the providing of a drug sample to a patient by a—

(A) practitioner licensed to prescribe such drug,

(B) health care professional acting at the direction and under the supervision of such a practitioner, or

(C) pharmacy of a hospital or of another health care entity that is acting at the direction of such a practitioner and that received such sample pursuant to paragraph (2) or (3).

(2)(A) The manufacturer or authorized distributor of record of a drug subject to subsection (b) may, in accordance with this paragraph, distribute drug samples by mail or common carrier to practitioners licensed to prescribe such drugs or, at the request of a licensed practitioner, to pharmacies of hospitals or other health care entities. Such a distribution of drug samples may only be made—

(i) in response to a written request for drug samples made on a form which meets the requirements of subparagraph (B), and

(ii) under a system which requires the recipient of the drug sample to execute a written receipt for the drug sample upon its delivery and the return of the receipt to the manufacturer or authorized distributor of record.

(B) A written request for a drug sample required by subparagraph (A)(i) shall contain—

(i) the name, address, professional designation, and signature of the practitioner making the request,

(ii) the identity of the drug sample requested and the quantity requested,

(iii) the name of the manufacturer of the drug sample requested, and

(iv) the date of the request.

(C) Each drug manufacturer or authorized distributor of record which makes distributions by mail or common carrier under this paragraph shall maintain, for a period of 3 years, the request forms submitted for such distributions and the receipts submitted for such distributions and shall maintain a record of distributions of drug samples which identifies the drugs distributed and the recipients of the distributions. Forms, receipts, and records required to be maintained under this subparagraph shall be made available by the drug manufacturer or authorized distributor of record to Federal and State officials engaged in the regulation of drugs and in the enforcement of laws applicable to drugs.

(3) The manufacturer or authorized distributor of record of a drug subject to subsection (b) may, by means other than mail or common carrier, distribute drug samples only if the manufacturer or authorized distributor of record makes the distributions in accordance with subparagraph (A) and carries out the activities described in subparagraphs (B) through (F) as follows:

(A) Drug samples may only be distributed—

(i) to practitioners licensed to prescribe such drugs if they make a written request for the drug samples, or

(ii) at the written request of such a licensed practitioner, to pharmacies of hospitals or other health care entities.

A written request for drug samples shall be made on a form which contains the practitioner's name, address, and professional designation, the identity of the drug sample requested, the quantity of drug samples requested, the name of the manufacturer or authorized distributor of record of the drug sample, the date of the request and signature of the practitioner making the request.

(B) Drug manufacturers or authorized distributors of record shall store drug samples under conditions that will maintain their stability, integrity, and effectiveness and will assure that the drug samples will be free of contamination, deterioration, and adulteration.

(C) Drug manufacturers or authorized distributors of record shall conduct, at least annually, a complete and accurate inventory of all drug samples in the possession of representatives of the manufacturer or authorized distributor of record. Drug manufacturers or authorized distributors of record shall maintain lists of the names and address of each of their representatives who distribute drug samples and of the sites where drug samples are stored. Drug manufacturers or authorized distributors of record shall maintain records for at least 3 years of all drug samples distributed, destroyed, or returned to the manufacturer or authorized distributor of record, of all inventories maintained under this subparagraph, of all thefts or significant losses of drug samples, and of all requests made under subparagraph (A) for drug samples. Records and lists maintained under this subparagraph shall be made available by the drug manufacturer or authorized distributor of record to the Secretary upon request.

(D) Drug manufacturers or authorized distributors of record shall notify the Secretary of any significant loss of drug samples and any known theft of drug samples.

(E) Drug manufacturers or authorized distributors of record shall report to the Secretary any conviction of their representatives for violations of subsection (c)(1) or a State law because of the sale, purchase, or trade of a drug sample or the offer to sell, purchase, or trade a drug sample.

(F) Drug manufacturers or authorized distributors of record shall provide to the Secretary the name and telephone number of the individual responsible for responding to a request for information respecting drug samples.

(4) In this subsection, the term "authorized distributors of record" means those distributors with whom a manufacturer has established an ongoing relationship to distribute such manufacturer's products.

(e) Licensing and reporting requirements for wholesale distributors; fees; definitions

(1) Requirement.—Subject to section 360eee–2 of this title:

(A) In general.—No person may engage in wholesale distribution of a drug subject to subsection (b)(1) in any State unless such person—

(i)(I) is licensed by the State from which the drug is distributed; or

(II) if the State from which the drug is distributed has not established a licensure requirement, is licensed by the Secretary; and

(ii) if the drug is distributed interstate, is licensed by the State into which the drug is distributed if the State into which the drug is distributed requires the licensure of a person that distributes drugs into the State.

(B) Standards.—Each Federal and State license described in subparagraph (A) shall meet the standards, terms, and conditions established by the Secretary under section 360eee–2 of this title.

(2) Reporting and database.—

(A) Reporting.—Beginning January 1, 2015, any person who owns or operates an establishment that engages in wholesale distribution shall—

(i) report to the Secretary, on an annual basis pursuant to a schedule determined by the Secretary—

(I) each State by which the person is licensed and the appropriate identification number of each such license; and

(II) the name, address, and contact information of each facility at which, and all trade names under which, the person conducts business; and

(ii) report to the Secretary within a reasonable period of time and in a reasonable manner, as determined by the Secretary, any significant disciplinary actions, such as the revocation or suspension of a wholesale distributor license, taken by a State or the Federal Government during the reporting period against the wholesale distributor.

(B) Database.—Not later than January 1, 2015, the Secretary shall establish a database of authorized wholesale distributors. Such database shall—

(i) identify each authorized wholesale distributor by name, contact information, and each State where such wholesale distributor is appropriately licensed to engage in wholesale distribution;

(ii) be available to the public on the Internet Web site of the Food and Drug Administration; and

(iii) be regularly updated on a schedule determined by the Secretary.

(C) Coordination.—The Secretary shall establish a format and procedure for appropriate State officials to access the information provided pursuant to subparagraph (A) in a prompt and secure manner.

(D) Confidentiality.—Nothing in this paragraph shall be construed as authorizing the Secretary to disclose any information that is a trade secret or confidential information subject to section 552(b)(4) of title 5 or section 1905 of title 18.

(3) Costs.—

(A) Authorized fees of secretary.—If a State does not establish a licensing program for persons engaged in the wholesale distribution of a drug subject to subsection (b), the Secretary shall license a person engaged in wholesale distribution located in such State and may collect a reasonable fee in such amount necessary to reimburse the Secretary for costs associated with establishing and administering the licensure program and conducting periodic inspections under this section. The Secretary shall adjust fee rates as needed on an annual basis to generate only the amount of revenue needed to perform this service. Fees authorized under this paragraph shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts. Such fees are authorized to remain available until expended. Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation.

(B) State licensing fees.—Nothing in this chapter shall prohibit States from collecting fees from wholesale distributors in connection with State licensing of such distributors.

(4) For the purposes of this subsection and subsection (d), the term "wholesale distribution" means the distribution of a drug subject to subsection (b) to a person other than a consumer or patient, or receipt of a drug subject to subsection (b) by a person other than the consumer or patient, but does not include—

(A) intracompany distribution of any drug between members of an affiliate or within a manufacturer;

(B) the distribution of a drug, or an offer to distribute a drug among hospitals or other health care entities which are under common control;

(C) the distribution of a drug or an offer to distribute a drug for emergency medical reasons, including a public health emergency declaration pursuant to section 319 of the Public Health Service Act [42 U.S.C. 247d], except that, for purposes of this paragraph, a drug shortage not caused by a public health emergency shall not constitute an emergency medical reason;

(D) the dispensing of a drug pursuant to a prescription executed in accordance with subsection (b)(1);

(E) the distribution of minimal quantities of drug by a licensed retail pharmacy to a licensed practitioner for office use;

(F) the distribution of a drug or an offer to distribute a drug by a charitable organization to a nonprofit affiliate of the organization to the extent otherwise permitted by law;

(G) the purchase or other acquisition by a dispenser, hospital, or other health care entity of a drug for use by such dispenser, hospital, or other health care entity;

(H) the distribution of a drug by the manufacturer of such drug;

(I) the receipt or transfer of a drug by an authorized third-party logistics provider provided that such third-party logistics provider does not take ownership of the drug;

(J) a common carrier that transports a drug, provided that the common carrier does not take ownership of the drug;

(K) the distribution of a drug, or an offer to distribute a drug by an authorized repackager that has taken ownership or possession of the drug and repacks it in accordance with section 360eee–1(e) of this title;

(L) salable drug returns when conducted by a dispenser;

(M) the distribution of a collection of finished medical devices, which may include a product or biological product, assembled in kit form strictly for the convenience of the purchaser or user (referred to in this subparagraph as a "medical convenience kit") if—

(i) the medical convenience kit is assembled in an establishment that is registered with the Food and Drug Administration as a device manufacturer in accordance with section 360(b)(2) of this title;

(ii) the medical convenience kit does not contain a controlled substance that appears in a schedule contained in the Comprehensive Drug Abuse Prevention and Control Act of 1970 [21 U.S.C. 801 et seq.];

(iii) in the case of a medical convenience kit that includes a product, the person that manufacturers the kit—

(I) purchased such product directly from the pharmaceutical manufacturer or from a wholesale distributor that purchased the product directly from the pharmaceutical manufacturer; and

(II) does not alter the primary container or label of the product as purchased from the manufacturer or wholesale distributor; and

(iv) in the case of a medical convenience kit that includes a product, the product is—

(I) an intravenous solution intended for the replenishment of fluids and electrolytes;

(II) a product intended to maintain the equilibrium of water and minerals in the body;

(III) a product intended for irrigation or reconstitution;

(IV) an anesthetic;

(V) an anticoagulant;

(VI) a vasopressor; or

(VII) a sympathomimetic;

(N) the distribution of an intravenous drug that, by its formulation, is intended for the replenishment of fluids and electrolytes (such as sodium, chloride, and potassium) or calories (such as dextrose and amino acids);

(O) the distribution of an intravenous drug used to maintain the equilibrium of water and minerals in the body, such as dialysis solutions;

(P) the distribution of a drug that is intended for irrigation, or sterile water, whether intended for such purposes or for injection;

(Q) the distribution of medical gas, as defined in section 360ddd of this title;

(R) facilitating the distribution of a product by providing solely administrative services, including processing of orders and payments; or

(S) the transfer of a product by a hospital or other health care entity, or by a wholesale distributor or manufacturer operating at the direction of the hospital or other health care entity, to a repackager described in section 360eee(16)(B) of this title and registered under section 360 of this title for the purpose of repackaging the drug for use by that hospital, or other health care entity and other health care entities that are under common control, if ownership of the drug remains with the hospital or other health care entity at all times.

(5) Third-party logistics providers.—Notwithstanding paragraphs (1) through (4), each entity that meets the definition of a third-party logistics provider under section 360eee(22) of this title shall obtain a license as a third-party logistics provider as described in section 360eee–3(a) of this title and is not required to obtain a license as a wholesale distributor if the entity never assumes an ownership interest in the product it handles.

(6) Affiliate.—For purposes of this subsection, the term "affiliate" means a business entity that has a relationship with a second business entity if, directly or indirectly—

(A) one business entity controls, or has the power to control, the other business entity; or

(B) a third party controls, or has the power to control, both of the business entities.

(f) Veterinary prescription drugs

(1)(A) A drug intended for use by animals other than man, other than a veterinary feed directive drug intended for use in animal feed or an animal feed bearing or containing a veterinary feed directive drug, which—

(i) because of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary for its use, is not safe for animal use except under the professional supervision of a licensed veterinarian, or

(ii) is limited by an approved application under subsection (b) of section 360b of this title, a conditionally-approved application under section 360ccc of this title, or an index listing under section 360ccc–1 of this title to use under the professional supervision of a licensed veterinarian,

shall be dispensed only by or upon the lawful written or oral order of a licensed veterinarian in the course of the veterinarian's professional practice.

(B) For purposes of subparagraph (A), an order is lawful if the order—

(i) is a prescription or other order authorized by law,

(ii) is, if an oral order, promptly reduced to writing by the person lawfully filling the order, and filed by that person, and

(iii) is refilled only if authorized in the original order or in a subsequent oral order promptly reduced to writing by the person lawfully filling the order, and filed by that person.

(C) The act of dispensing a drug contrary to the provisions of this paragraph shall be deemed to be an act which results in the drug being misbranded while held for sale.

(2) Any drug when dispensed in accordance with paragraph (1) of this subsection—

(A) shall be exempt from the requirements of section 352 of this title, except subsections (a), (g), (h), (i)(2), (i)(3), and (p) of such section, and

(B) shall be exempt from the packaging requirements of subsections (g), (h), and (p) of such section, if—

(i) when dispensed by a licensed veterinarian, the drug bears a label containing the name and address of the practitioner and any directions for use and cautionary statements specified by the practitioner, or

(ii) when dispensed by filling the lawful order of a licensed veterinarian, the drug bears a label containing the name and address of the dispenser, the serial number and date of the order or of its filling, the name of the licensed veterinarian, and the directions for use and cautionary statements, if any, contained in such order.

The preceding sentence shall not apply to any drug dispensed in the course of the conduct of a business of dispensing drugs pursuant to diagnosis by mail.

(3) The Secretary may by regulation exempt drugs for animals other than man subject to section 360b, 360ccc, or 360ccc–1 of this title from the requirements of paragraph (1) when such requirements are not necessary for the protection of the public health.

(4) A drug which is subject to paragraph (1) shall be deemed to be misbranded if at any time prior to dispensing its label fails to bear the statement "Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.". A drug to which paragraph (1) does not apply shall be deemed to be misbranded if at any time prior to dispensing its label bears the statement specified in the preceding sentence.

(g) Regulation of combination products

(1)(A) The Secretary shall, in accordance with this subsection, assign a primary agency center to regulate products that constitute a combination of a drug, device, or biological product.

(B) The Secretary shall conduct the premarket review of any combination product under a single application, whenever appropriate.

(C) For purposes of this subsection, the term "primary mode of action" means the single mode of action of a combination product expected to make the greatest contribution to the overall intended therapeutic effects of the combination product.

(D) The Secretary shall determine the primary mode of action of the combination product. If the Secretary determines that the primary mode of action is that of—

(i) a drug (other than a biological product), the agency center charged with premarket review of drugs shall have primary jurisdiction;

(ii) a device, the agency center charged with premarket review of devices shall have primary jurisdiction; or

(iii) a biological product, the agency center charged with premarket review of biological products shall have primary jurisdiction.

(E) In determining the primary mode of action of a combination product, the Secretary shall not determine that the primary mode of action is that of a drug or biological product solely because the combination product has any chemical action within or on the human body.

(F) If a sponsor of a combination product disagrees with the determination under subparagraph (D)—

(i) such sponsor may request, and the Secretary shall provide, a substantive rationale to such sponsor that references scientific evidence provided by the sponsor and any other scientific evidence relied upon by the Secretary to support such determination; and

(ii)(I) the sponsor of the combination product may propose one or more studies (which may be nonclinical, clinical, or both) to establish the relevance, if any, of the chemical action in achieving the primary mode of action of such product;

(II) if the sponsor proposes any such studies, the Secretary and the sponsor of such product shall collaborate and seek to reach agreement, within a reasonable time of such proposal, not to exceed 90 calendar days, on the design of such studies; and

(III) if an agreement is reached under subclause (II) and the sponsor conducts one or more of such studies, the Secretary shall consider the data resulting from any such study when reevaluating the determination of the primary mode of action of such product, and unless and until such reevaluation has occurred and the Secretary issues a new determination, the determination of the Secretary under subparagraph (D) shall remain in effect.

(2)(A) 1 (i) To establish clarity and certainty for the sponsor, the sponsor of a combination product may request a meeting on such combination product. If the Secretary concludes that a determination of the primary mode of action pursuant to paragraph (1)(D) is necessary, the sponsor may request such meeting only after the Secretary makes such determination. If the sponsor submits a written meeting request, the Secretary shall, not later than 75 calendar days after receiving such request, meet with the sponsor of such combination product.

(ii) A meeting under clause (i) may—

(I) address the standards and requirements for market approval or clearance of the combination product;

(II) address other issues relevant to such combination product, such as requirements related to postmarket modification of such combination product and good manufacturing practices applicable to such combination product; and

(III) identify elements under subclauses (I) and (II) that may be more appropriate for discussion and agreement with the Secretary at a later date given that scientific or other information is not available, or agreement is otherwise not feasible regarding such elements, at the time a request for such meeting is made.

(iii) Any agreement under this subparagraph shall be in writing and made part of the administrative record by the Secretary.

(iv) Any such agreement shall remain in effect, except—

(I) upon the written agreement of the Secretary and the sponsor or applicant; or

(II) pursuant to a decision by the director of the reviewing division of the primary agency center, or a person more senior than such director, in consultation with consulting centers and the Office, as appropriate, that an issue essential to determining whether the standard for market clearance or other applicable standard under this chapter or the Public Health Service Act [42 U.S.C. 201 et seq.] applicable to the combination product has been identified since the agreement was reached, or that deviating from the agreement is otherwise justifiable based on scientific evidence, for public health reasons.

(3) For purposes of conducting the premarket review of a combination product that contains an approved constituent part described in paragraph (4), the Secretary may require that the sponsor of such combination product submit to the Secretary only data or information that the Secretary determines is necessary to meet the standard for clearance or approval, as applicable, under this chapter or the Public Health Service Act, including any incremental risks and benefits posed by such combination product, using a risk-based approach and taking into account any prior finding of safety and effectiveness or substantial equivalence for the approved constituent part relied upon by the applicant in accordance with paragraph (5).

(4) For purposes of paragraph (3), an approved constituent part is—

(A) a drug constituent part of a combination product being reviewed in a single application or request under section 360e, 360(k), or 360c(f)(2) of this title (submitted in accordance with paragraph (5)), that is an approved drug, provided such application or request complies with paragraph (5);

(B) a device constituent part approved under section 360e of this title that is referenced by the sponsor and that is available for use by the Secretary under section 360j(h)(4) of this title; or

(C) any constituent part that was previously approved, cleared, or classified under section 355, 360(k), 360c(f)(2), or 360e of this title for which the sponsor has a right of reference or any constituent part that is a nonprescription drug, as defined in section 379aa(a)(2) of this title.

(5)(A) If an application is submitted under section 360e or 360(k) of this title or a request is submitted under section 360c(f)(2) of this title, consistent with any determination made under paragraph (1)(D), for a combination product containing as a constituent part an approved drug—

(i) the application or request shall include the certification or statement described in section 355(b)(2) of this title; and

(ii) the applicant or requester shall provide notice as described in section 355(b)(3) of this title.

(B) For purposes of this paragraph and paragraph (4), the term "approved drug" means an active ingredient—

(i) that was in an application previously approved under section 355(c) of this title;

(ii) where such application is relied upon by the applicant submitting the application or request described in subparagraph (A);

(iii) for which full reports of investigations that have been made to show whether such drug is safe for use and whether such drug is effective in use were not conducted by or for the applicant submitting the application or request described in subparagraph (A); and

(iv) for which the applicant submitting the application or request described in subparagraph (A) has not obtained a right of reference or use from the person by or for whom the investigations described in clause (iii) were conducted.

(C) The following provisions shall apply with respect to an application or request described in subparagraph (A) to the same extent and in the same manner as if such application or request were an application described in section 355(b)(2) of this title that referenced the approved drug:

(i) Subparagraphs (A), (B), (C), and (D) of section 355(c)(3) of this title.

(ii) Clauses (ii), (iii), and (iv) of section 355(c)(3)(E) of this title.

(iii) Subsections (b) and (c) of section 355a of this title.

(iv) Section 355f(a) of this title.

(v) Section 360cc(a) of this title.

(D) Notwithstanding any other provision of this subsection, an application or request for classification for a combination product described in subparagraph (A) shall be considered an application submitted under section 355(b)(2) of this title for purposes of section 271(e)(2)(A) of title 35.

(6) Nothing in this subsection shall be construed as prohibiting a sponsor from submitting separate applications for the constituent parts of a combination product, unless the Secretary determines that a single application is necessary.

(7) Nothing in this subsection shall prevent the Secretary from using any agency resources of the Food and Drug Administration necessary to ensure adequate review of the safety, effectiveness, or substantial equivalence of an article.

(8)(A) Not later than 60 days after October 26, 2002, the Secretary shall establish within the Office of the Commissioner of Food and Drugs an office to ensure the prompt assignment of combination products to agency centers, the timely and effective premarket review of such products, and consistent and appropriate postmarket regulation of like products subject to the same statutory requirements to the extent permitted by law. Additionally, the office shall, in determining whether a product is to be designated a combination product, consult with the component within the Office of the Commissioner of Food and Drugs that is responsible for such determinations. Such office (referred to in this paragraph as the "Office") shall have appropriate scientific and medical expertise, and shall be headed by a director.

(B) In carrying out this subsection, the Office shall, for each combination product, promptly assign an agency center with primary jurisdiction in accordance with paragraph (1) for the premarket review of such product.

(C)(i) In carrying out this subsection, the Office shall help to ensure timely and effective premarket review that involves more than one agency center by coordinating such reviews, overseeing the timeliness of such reviews, and overseeing the alignment of feedback regarding such reviews.

(ii) In order to ensure the timeliness and alignment of the premarket review of a combination product, the agency center with primary jurisdiction for the product, and the consulting agency center, shall be responsible to the Office with respect to the timeliness and alignment of the premarket review.

(iii) The Office shall ensure that, with respect to a combination product, a designated person or persons in the primary agency center is the primary point or points of contact for the sponsor of such combination product. The Office shall also coordinate communications to and from any consulting center involved in such premarket review, if requested by such primary agency center or any such consulting center. Agency communications and commitments, to the extent consistent with other provisions of law and the requirements of all affected agency centers, from the primary agency center shall be considered as communication from the Secretary on behalf of all agency centers involved in the review.

(iv) The Office shall, with respect to the premarket review of a combination product—

(I) ensure that any meeting between the Secretary and the sponsor of such product is attended by each agency center involved in the review, as appropriate;

(II) ensure that each consulting agency center has completed its premarket review and provided the results of such review to the primary agency center in a timely manner; and

(III) ensure that each consulting center follows the guidance described in clause (vi) and advises, as appropriate, on other relevant regulations, guidances, and policies.

(v) In seeking agency action with respect to a combination product, the sponsor of such product—

(I) shall identify the product as a combination product; and

(II) may request in writing the participation of representatives of the Office in meetings related to such combination product, or to have the Office otherwise engage on such regulatory matters concerning the combination product.

(vi) Not later than 4 years after December 13, 2016, and after a public comment period of not less than 60 calendar days, the Secretary shall issue a final guidance that describes—

(I) the structured process for managing pre-submission interactions with sponsors developing combination products;

(II) the best practices for ensuring that the feedback in such pre-submission interactions represents the Agency's best advice based on the information provided during such pre-submission interactions; 2

(III) the information that is required to be submitted with a meeting request under paragraph (2), how such meetings relate to other types of meetings in the Food and Drug Administration, and the form and content of any agreement reached through a meeting under such paragraph (2); 3

(D) In carrying out this subsection, the Office shall ensure the consistency and appropriateness of postmarket regulation of like products subject to the same statutory requirements to the extent permitted by law.

(E)(i) Any dispute regarding the timeliness of the premarket review of a combination product may be presented to the Office for resolution, unless the dispute is clearly premature.

(ii) During the review process, any dispute regarding the substance of the premarket review may be presented to the Commissioner of Food and Drugs after first being considered by the agency center with primary jurisdiction of the premarket review, under the scientific dispute resolution procedures for such center. The Commissioner of Food and Drugs shall consult with the Director of the Office in resolving the substantive dispute.

(F) The Secretary, acting through the Office, shall review each agreement, guidance, or practice of the Secretary that is specific to the assignment of combination products to agency centers and shall determine whether the agreement, guidance, or practice is consistent with the requirements of this subsection. In carrying out such review, the Secretary shall consult with stakeholders and the directors of the agency centers. After such consultation, the Secretary shall determine whether to continue in effect, modify, revise, or eliminate such agreement, guidance, or practice, and shall publish in the Federal Register a notice of the availability of such modified or revised agreement, guidance or practice. Nothing in this paragraph shall be construed as preventing the Secretary from following each agreement, guidance, or practice until continued, modified, revised, or eliminated.

(G) Not later than one year after October 26, 2002 (except with respect to clause (iv), beginning not later than one year after December 13, 2016), and annually thereafter, the Secretary shall report to the appropriate committees of Congress on the activities and impact of the Office. The report shall include provisions—

(i) describing the numbers and types of combination products under review and the timeliness in days of such assignments, reviews, and dispute resolutions;

(ii) identifying the number of premarket reviews of such products that involved a consulting agency center;

(iii) describing improvements in the consistency of postmarket regulation of combination products; and

(iv) identifying the percentage of combination products for which a dispute resolution, with respect to premarket review, was requested by the combination product's sponsor.

(H) Nothing in this paragraph shall be construed to limit the regulatory authority of any agency center.

(9) As used in this subsection:

(A) The term "agency center" means a center or alternative organizational component of the Food and Drug Administration.

(B) The term "biological product" has the meaning given the term in section 351(i) of the Public Health Service Act (42 U.S.C. 262(i)).

(C) The term "market clearance" includes—

(i) approval of an application under section 355, 357,4 360e, or 360j(g) of this title;

(ii) a finding of substantial equivalence under this part;

(iii) approval of a biologics license application under subsection (a) of section 351 of the Public Health Service Act (42 U.S.C. 262); and

(iv) de novo classification under section 360c(a)(1) of this title.

(D) The terms "premarket review" and "reviews" include all activities of the Food and Drug Administration conducted prior to approval or clearance of an application, notification, or request for classification submitted under section 355, 360(k), 360c(f)(2), 360e, or 360j of this title or under section 351 of the Public Health Service Act [42 U.S.C. 262], including with respect to investigational use of the product.

(h) Regulation of certain products as drugs

(1) Any contrast agent, radioactive drug, or OTC monograph drug shall be deemed to be a drug under section 321(g) of this title and not a device under section 321(h) of this title.

(2) For purposes of this subsection:

(A) The term "contrast agent" means an article that is intended for use in conjunction with a medical imaging device, and—

(i) is a diagnostic radiopharmaceutical, as defined in sections 315.2 and 601.31 of title 21, Code of Federal Regulations (or any successor regulations); or

(ii) is a diagnostic agent that improves the visualization of structure or function within the body by increasing the relative difference in signal intensity within the target tissue, structure, or fluid.

(B) The term "radioactive drug" has the meaning given such term in section 310.3(n) of title 21, Code of Federal Regulations (or any successor regulations), except that such term does not include—

(i) an implant or article similar to an implant;

(ii) an article that applies radiation from outside of the body; or

(iii) the radiation source of an article described in clause (i) or (ii).

(C) The term "OTC monograph drug" has the meaning given such term in section 379j–71 of this title.

(3) Nothing in this subsection shall be construed as allowing for the classification of a product as a drug (as defined in section 321(g) of this title) if such product—

(A) is not described in paragraph (1); and

(B) meets the definition of a device under section 321(h) of this title,

unless another provision of this chapter otherwise indicates a different classification.

(4) The Secretary shall waive the application fee under sections 379h and 379j–42 of this title for applications for drugs that are—

(A) on September 30, 2022, legally marketed as devices; and

(B) deemed drugs pursuant to paragraph (1) 5

(June 25, 1938, ch. 675, §503, 52 Stat. 1051; Oct. 26, 1951, ch. 578, §1, 65 Stat. 648; Pub. L. 87–781, title I, §104(e)(2), Oct. 10, 1962, 76 Stat. 785; Pub. L. 91–601, §6(e), formerly §7(e), Dec. 30, 1970, 84 Stat. 1673, renumbered Pub. L. 97–35, title XII, §1205(c), Aug. 13, 1981, 95 Stat. 716; Pub. L. 100–293, §§4–6, Apr. 22, 1988, 102 Stat. 96–98; Pub. L. 100–670, title I, §105, Nov. 16, 1988, 102 Stat. 3983; Pub. L. 101–629, §16(a), Nov. 28, 1990, 104 Stat. 4526; Pub. L. 102–108, §2(d), Aug. 17, 1991, 105 Stat. 550; Pub. L. 102–300, §6(d), June 16, 1992, 106 Stat. 240; Pub. L. 102–353, §§2(a)–(c), 4, Aug. 26, 1992, 106 Stat. 941, 942; Pub. L. 104–250, §5(a), Oct. 9, 1996, 110 Stat. 3155; Pub. L. 105–115, title I, §§123(e), 126(a), (c)(1), (2), Nov. 21, 1997, 111 Stat. 2324, 2327, 2328; Pub. L. 107–250, title II, §204, Oct. 26, 2002, 116 Stat. 1611; Pub. L. 108–282, title I, §102(b)(5)(F), Aug. 2, 2004, 118 Stat. 903; Pub. L. 113–54, title II, §204(a)(1)–(4), (b), Nov. 27, 2013, 127 Stat. 630–635; Pub. L. 114–255, div. A, title III, §3038(a), Dec. 13, 2016, 130 Stat. 1105; Pub. L. 117–328, div. FF, title III, §3621, Dec. 29, 2022, 136 Stat. 5877.)

Editorial Notes

References in Text

The Comprehensive Drug Abuse Prevention and Control Act of 1970, referred to in subsec. (e)(4)(M)(ii), is Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1236, which is classified principally to chapter 13 (§801 et seq.) of this title. For complete classification of this Act to the Code, see Short Title note set out under section 801 of this title and Tables.

The Public Health Service Act, referred to in subsec. (g)(2)(A)(iv)(II), (3), is act July 1, 1944, ch. 373, 58 Stat. 682, which is classified generally to chapter 6A (§201 et seq.) of Title 42, The Public Health and Welfare. For complete classification of this Act to the Code, see Short Title note set out under section 201 of Title 42 and Tables.

Section 357 of this title, referred to in subsec. (g)(9)(C)(i), was repealed by Pub. L. 105–115, title I, §125(b)(1), Nov. 21, 1997, 111 Stat. 2325.

Codification

In subsec. (b)(5), "sections 4721, 6001, and 6151 of title 26" and "section 4761 of title 26" substituted for "section 3220 of the Internal Revenue Code (26 U.S.C. 3220)" and "section 3238(b) of the Internal Revenue Code (26 U.S.C. 3238(b))", respectively, on authority of section 7852(b) of Title 26, Internal Revenue Code.

Amendments

2022—Subsec. (h). Pub. L. 117–328 added subsec. (h).

2016—Subsec. (g)(1). Pub. L. 114–255, §3038(a)(4), added par. (1) and struck out former par. (1) which read as follows: "The Secretary shall in accordance with this subsection assign an agency center to regulate products that constitute a combination of a drug, device, or biological product. The Secretary shall determine the primary mode of action of the combination product. If the Secretary determines that the primary mode of action is that of—

"(A) a drug (other than a biological product), the agency center charged with premarket review of drugs shall have primary jurisdiction,

"(B) a device, the agency center charged with premarket review of devices shall have primary jurisdiction, or

"(C) a biological product, the agency center charged with premarket review of biological products shall have primary jurisdiction."

Subsec. (g)(2). Pub. L. 114–255, §3038(a)(4), added par. (2). Former par. (2) redesignated (7).

Subsec. (g)(3). Pub. L. 114–255, §3038(a)(1), (4), added par. (3) and struck out former par. (3) which read as follows: "The Secretary shall promulgate regulations to implement market clearance procedures in accordance with paragraphs (1) and (2) not later than 1 year after November 28, 1990."

Subsec. (g)(4) to (6). Pub. L. 114–255, §3038(a)(4), added pars. (4) to (6). Former pars. (4) and (5) redesignated (8) and (9), respectively.

Subsec. (g)(7). Pub. L. 114–255, §3038(a)(2), redesignated par. (2) as (7).

Subsec. (g)(8). Pub. L. 114–255, §3038(a)(3), redesignated par. (4) as (8).

Subsec. (g)(8)(C)(i). Pub. L. 114–255, §3038(a)(5)(A)(i), amended cl. (i) generally. Prior to amendment, cl. (i) read as follows: "In carrying out this subsection, the Office shall ensure timely and effective premarket reviews by overseeing the timeliness of and coordinating reviews involving more than one agency center."

Subsec. (g)(8)(C)(ii). Pub. L. 114–255, §3038(a)(5)(A)(ii), inserted "and alignment" after "the timeliness" in two places.

Subsec. (g)(8)(C)(iii) to (vi). Pub. L. 114–255, §3038(a)(5)(A)(iii), added cls. (iii) to (vi).

Subsec. (g)(8)(G). Pub. L. 114–255, §3038(a)(5)(B)(i), inserted "(except with respect to clause (iv), beginning not later than one year after December 13, 2016)" after "October 26, 2002" in introductory provisions.

Subsec. (g)(8)(G)(iv). Pub. L. 114–255, §3038(a)(5)(B)(ii)–(iv), added cl. (iv).

Subsec. (g)(9). Pub. L. 114–255, §3038(a)(3), redesignated par. (5) as (9).

Subsec. (g)(9)(C). Pub. L. 114–255, §3038(a)(6)(A), substituted semicolon for comma at end of cl. (i), semicolon for ", and" at end of cl. (ii), and "; and" for period at end of cl. (iii), and added cl. (iv).

Subsec. (g)(9)(D). Pub. L. 114–255, §3038(a)(6)(B), added subpar. (D).

2013—Subsec. (d)(4). Pub. L. 113–54, §204(b), added par. (4).

Subsec. (e). Pub. L. 113–54, §204(a)(1)–(4), added pars. (1) to (6) and struck out former pars. (1) to (3). Prior to amendment, pars. (1) to (3) set out certain disclosure and licensing requirements for wholesale distributors and defined "authorized distributors of record" and "wholesale distribution".

2004—Subsec. (f)(1)(A)(ii). Pub. L. 108–282, §102(b)(5)(F)(i), substituted "360b of this title, a conditionally-approved application under section 360ccc of this title, or an index listing under section 360ccc–1 of this title" for "360b of this title".

Subsec. (f)(3). Pub. L. 108–282, §102(b)(5)(F)(ii), substituted "section 360b, 360ccc, or 360ccc–1" for "section 360b".

2002—Subsec. (g)(1). Pub. L. 107–250, §204(1)(A), substituted "shall in accordance with this subsection assign an agency center" for "shall designate a component of the Food and Drug Administration" in first sentence of introductory provisions.

Subsec. (g)(1)(A) to (C). Pub. L. 107–250, §204(1)(B), substituted "the agency center charged" for "the persons charged".

Subsec. (g)(4). Pub. L. 107–250, §204(3), added par. (4). Former par. (4) redesignated (5).

Subsec. (g)(5). Pub. L. 107–250, §204(2), (4), redesignated par. (4) as (5), added subpar. (A), and redesignated former subpars. (A) and (B) as (B) and (C), respectively.

1997—Subsec. (b)(1)(A) to (C). Pub. L. 105–115, §126(c)(1), redesignated subpars. (B) and (C) as (A) and (B), respectively, and struck out former subpar. (A), which read as follows: "is a habit-forming drug to which section 352(d) of this title applies; or".

Subsec. (b)(3). Pub. L. 105–115, §126(c)(2), struck out reference to section 352(d) of this title before "355".

Subsec. (b)(4). Pub. L. 105–115, §126(a), amended par. (4) generally. Prior to amendment, par. (4) read as follows: "A drug which is subject to paragraph (1) of this subsection shall be deemed to be misbranded if at any time prior to dispensing its label fails to bear the statement 'Caution: Federal law prohibits dispensing without prescription'. A drug to which paragraph (1) of this subsection does not apply shall be deemed to be misbranded if at any time prior to dispensing its label bears the caution statement quoted in the preceding sentence."

Subsec. (g)(4)(A). Pub. L. 105–115, §123(e)(1), substituted "section 351(i)" for "section 351(a)" and "262(i)" for "262(a)".

Subsec. (g)(4)(B)(iii). Pub. L. 105–115, §123(e)(2), substituted "biologics license application under subsection (a)" for "product or establishment license under subsection (a) or (d)".

1996—Subsec. (f)(1)(A). Pub. L. 104–250 inserted ", other than a veterinary feed directive drug intended for use in animal feed or an animal feed bearing or containing a veterinary feed directive drug," after "other than man" in introductory provisions.

1992—Subsec. (d)(1). Pub. L. 102–353, §4(1), amended par. (1) generally. Prior to amendment, par. (1) read as follows: "Except as provided in paragraphs (2) and (3), no representative of a drug manufacturer or distributor may distribute any drug sample."

Subsec. (d)(2). Pub. L. 102–353, §4(2), substituted "authorized distributor of record" for "distributor" wherever appearing.

Subsec. (d)(3). Pub. L. 102–353, §4(2), substituted "authorized distributor of record" for "distributor" and "authorized distributors of record" for "distributors" wherever appearing.

Subsec. (e)(1). Pub. L. 102–353, §4(3), amended par. (1) generally. Prior to amendment, par. (1) read as follows: "Each person who is engaged in the wholesale distribution of drugs subject to subsection (b) of this section and who is not an authorized distributor of record of such drugs shall provide to each wholesale distributor of such drugs a statement identifying each sale of the drug (including the date of the sale) before the sale to such wholesale distributor. Each manufacturer shall maintain at its corporate offices a current list of such authorized distributors."

Subsec. (e)(2)(A). Pub. L. 102–353, §2(a), (d), temporarily inserted "or has registered with the Secretary in accordance with paragraph (3)". See Termination Date of 1992 Amendment note below.

Subsec. (e)(3). Pub. L. 102–353, §2(b), (d), temporarily added par. (3). Former par. (3) redesignated (4). See Termination Date of 1992 Amendment note below.

Subsec. (e)(4). Pub. L. 102–353, §4(4), inserted "and subsection (d) of this section" after "For the purposes of this subsection".

Pub. L. 102–353, §2(b), (d), temporarily redesignated par. (3) as (4). See Termination Date of 1992 Amendment note below.

Subsec. (f)(1)(B). Pub. L. 102–353, §2(c), which directed the substitution of "an order" for "and order", could not be executed because "and order" did not appear in subpar. (B).

Subsec. (g)(3). Pub. L. 102–300 substituted "clearance" for "approval".

1991—Subsec. (c). Pub. L. 102–108, §2(d)(3), redesignated subsec. (c), relating to veterinary prescription drugs, as (f). Former subsec. (f) redesignated (g).

Subsec. (c)(2), (3)(B)(v). Pub. L. 102–108, §2(d)(1), made technical amendment to reference to subsection (b) of this section involving corresponding provision of original act.

Subsec. (d)(3)(E). Pub. L. 102–108, §2(d)(2), made technical amendment to reference to subsection (c)(1) of this section involving corresponding provision of original act.

Subsec. (f). Pub. L. 102–108, §2(d)(4), redesignated subsec. (f), relating to regulation of combination products, as (g).

Pub. L. 102–108, §2(d)(3), redesignated subsec. (c), relating to veterinary prescription drugs, as (f).

Subsec. (g). Pub. L. 102–108, §2(d)(4), redesignated subsec. (f), relating to regulation of combination products, as (g).

1990—Pub. L. 101–629, §16(a)(1), substituted "Exemptions and consideration for certain drugs, devices, and biological products" for "Exemptions in case of drugs and devices" in section catchline.

Subsec. (f). Pub. L. 101–629, §16(a)(2), added subsec. (f).

1988—Subsec. (c). Pub. L. 100–670 added subsec. (c) relating to veterinary prescription drugs.

Pub. L. 100–293, §4, added subsec. (c) relating to sales restrictions.

Subsec. (d). Pub. L. 100–293, §5, added subsec. (d).

Subsec. (e). Pub. L. 100–293, §6, added subsec. (e).

1970—Subsec. (b)(2). Pub. L. 91–601 included exemption from packaging requirements of subsec. (p) of section 352 of this title.

1962—Subsec. (b)(1)(C). Pub. L. 87–781 substituted "approved" for "effective".

1951—Subsec. (b). Act Oct. 26, 1951, amended subsec. (b) generally to protect the public from abuses in the sale of potent prescription drugs, and to relieve retail pharmacists and the public from unnecessary restrictions on the dispensation of drugs that are safe to use without supervision of a doctor.

Statutory Notes and Related Subsidiaries

Effective Date of 2013 Amendment

Pub. L. 113–54, title II, §204(c), Nov. 27, 2013, 127 Stat. 636, provided that: "The amendments made by subsections (a) and (b) [enacting section 360eee–2 of this title and amending this section] shall take effect on January 1, 2015."

Effective Date of 1997 Amendment

Amendment by Pub. L. 105–115 effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as a note under section 321 of this title.

Termination Date of 1992 Amendment

Pub. L. 102–353, §2(d), Aug. 26, 1992, 106 Stat. 941, provided that: "Effective September 14, 1994, the amendments made by subsections (a) and (b) [amending this section] shall no longer be in effect."

Effective Date of 1988 Amendment

Pub. L. 100–293, §8, Apr. 22, 1988, 102 Stat. 100, provided that:

"(a) General Rule.—Except as provided in subsection (b), this Act and the amendments made by this Act [amending this section and sections 331, 333, and 381 of this title and enacting provisions set out as notes under this section and section 301 of this title] shall take effect upon the expiration of 90 days after the date of the enactment of this Act [Apr. 22, 1988].

"(b) Exception.—

"(1) Section 503(d) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 353(d)] (as added by section 5 of this Act) shall take effect upon the expiration of 180 days after the date of the enactment of this Act [Apr. 22, 1988].

"(2) The Secretary of Health and Human Services shall by regulation issue the guidelines required by section 503(e)(2)(B) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 353(e)(2)(B)] (as added by section 6 of this Act) not later than 180 days after the date of the enactment of this Act. Section 503(e)(2)(A) of such Act shall take effect upon the expiration of 2 years after the date such regulations are promulgated and take effect."

Effective Date of 1970 Amendment

Amendment by Pub. L. 91–601 effective Dec. 30, 1970, and regulations establishing special packaging standards effective no sooner than 180 days or later than one year from date regulations are final, or an earlier date published in Federal Register, see section 8 of Pub. L. 91–601, set out as an Effective Date note under section 1471 of Title 15, Commerce and Trade.

Effective Date of 1962 Amendment

Amendment by Pub. L. 87–781 effective Oct. 10, 1962, see section 107 of Pub. L. 87–781, set out as a note under section 321 of this title.

Effective Date of 1951 Amendment

Amendment by act Oct. 26, 1951, effective six months after Oct. 26, 1951, see section 3 of act Oct. 26, 1951, set out as a note under section 333 of this title.

Effective Medication Guides

Pub. L. 104–180, title VI, §601, Aug. 6, 1996, 110 Stat. 1593, provided that:

"(a) In General.—Not later than 30 days after the date of enactment of this Act [Aug. 6, 1996], the Secretary of the Department of Health and Human Services shall request that national organizations representing health care professionals, consumer organizations, voluntary health agencies, the pharmaceutical industry, drug wholesalers, patient drug information database companies, and other relevant parties collaborate to develop a long-range comprehensive action plan to achieve goals consistent with the goals of the proposed rule of the Food and Drug Administration on 'Prescription Drug Product Labeling: Medication Guide Requirements' (60 Fed. Reg. 44182; relating to the provision of oral and written prescription information to consumers).

"(b) Goals.—Goals consistent with the proposed rule described in subsection (a) are the distribution of useful written information to 75 percent of individuals receiving new precriptions [sic] by the year 2000 and to 95 percent by the year 2006.

"(c) Plan.—The plan described in subsection (a) shall—

"(1) identify the plan goals;

"(2) assess the effectiveness of the current private-sector approaches used to provide oral and written prescription information to consumers;

"(3) develop guidelines for providing effective oral and written prescription information consistent with the findings of any such assessment;

"(4) contain elements necessary to ensure the transmittal of useful information to the consuming public, including being scientifically accurate, non-promotional in tone and content, sufficiently specific and comprehensive as to adequately inform consumers about the use of the product, and in an understandable, legible format that is readily comprehensible and not confusing to consumers expected to use the product.[;]

"(5) develop a mechanism to assess periodically the quality of the oral and written prescription information and the frequency with which the information is provided to consumers; and

"(6) provide for compliance with relevant State board regulations.

"(d) Limitation on the Authority of the Secretary.—The Secretary of the Department of Health and Human Services shall have no authority to implement the proposed rule described in subsection (a), or to develop any similar regulation, policy statement, or other guideline specifying a uniform content or format for written information voluntarily provided to consumers about prescription drugs if, (1) not later than 120 days after the date of enactment of this Act [Aug. 6, 1996], the national organizations described in subsection (a) develop and submit to the Secretary for Health and Human Services a comprehensive, long-range action plan (as described in subsection (a)) which shall be acceptable to the Secretary of Health and Human Services; (2) the aforementioned plan is submitted to the Secretary of Health and Human Services for review and acceptance: Provided, That the Secretary shall give due consideration to the submitted plan and that any such acceptance shall not be arbitrarily withheld; and (3) the implementation of (a) a plan accepted by the Secretary commences within 30 days of the Secretary's acceptance of such plan, or (b) the plan submitted to the Secretary commences within 60 days of the submission of such plan if the Secretary fails to take any action on the plan within 30 days of the submission of the plan. The Secretary shall accept, reject or suggest modifications to the plan submitted within 30 days of its submission. The Secretary may confer with and assist private parties in the development of the plan described in subsections (a) and (b).

"(e) Secretary Review.—Not later than January 1, 2001, the Secretary of the Department of Health and Human Services shall review the status of private-sector initiatives designed to achieve the goals of the plan described in subsection (a), and if such goals are not achieved, the limitation in subsection (d) shall not apply, and the Secretary shall seek public comment on other initiatives that may be carried out to meet such goals."

Congressional Findings

Pub. L. 100–293, §2, Apr. 22, 1988, 102 Stat. 95, provided that: "The Congress finds the following:

"(1) American consumers cannot purchase prescription drugs with the certainty that the products are safe and effective.

"(2) The integrity of the distribution system for prescription drugs is insufficient to prevent the introduction and eventual retail sale of substandard, ineffective, or even counterfeit drugs.

"(3) The existence and operation of a wholesale submarket, commonly known as the 'diversion market', prevents effective control over or even routine knowledge of the true sources of prescription drugs in a significant number of cases.

"(4) Large amounts of drugs are being reimported to the United States as American goods returned. These imports are a health and safety risk to American consumers because they may have become subpotent or adulterated during foreign handling and shipping.

"(5) The ready market for prescription drug reimports has been the catalyst for a continuing series of frauds against American manufacturers and has provided the cover for the importation of foreign counterfeit drugs.

"(6) The existing system of providing drug samples to physicians through manufacturer's representatives has been abused for decades and has resulted in the sale to consumers of misbranded, expired, and adulterated pharmaceuticals.

"(7) The bulk resale of below wholesale priced prescription drugs by health care entities, for ultimate sale at retail, helps fuel the diversion market and is an unfair form of competition to wholesalers and retailers that must pay otherwise prevailing market prices.

"(8) The effect of these several practices and conditions is to create an unacceptable risk that counterfeit, adulterated, misbranded, subpotent, or expired drugs will be sold to American consumers."

Executive Documents

Transfer of Functions

For transfer of functions of Federal Security Administrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration in the Department of Agriculture to Federal Security Agency, see notes set out under section 321 of this title.

1 So in original. No subpar. (B) has been enacted.

2 So in original. The word "and" probably should appear.

3 So in original. The semicolon probably should be a period.

4 See References in Text note below.

5 So in original. Probably should be followed by a period.
21 U.S.C. § 1054 (2024) — Title 21: FOOD AND DRUGS / Chapter 15: EGG PRODUCTS INSPECTION / Section 1054: Annual report to Congressional committees
Annual report to Congressional committees
Status: in_force

(a) 1 Not later than March 1 of each year following December 29, 1970, the Secretary shall submit to the Committee on Agriculture of the House of Representatives and the Committee on Agriculture, Nutrition, and Forestry of the Senate a comprehensive and detailed written report with respect to—

(1) the processing, storage, handling, and distribution of eggs and egg products subject to the provisions of this chapter; the inspection of establishments operated in connection therewith; the effectiveness of the operation of the inspection, including the effectiveness of the operations of State egg inspection programs; and recommendations for legislation to improve such program; and

(2) the administration of section 1046 of this title (relating to imports) during the immediately preceding calendar year, including but not limited to—

(A) a certification by the Secretary that foreign plants exporting eggs or egg products to the United States have complied with requirements of this chapter and regulations issued thereunder;

(B) the names and locations of plants authorized or permitted to export eggs or egg products to the United States;

(C) the number of inspectors employed by the Department of Agriculture in the calendar year concerned who were assigned to inspect plants referred to in paragraph (B) hereof and the frequency with which each such plant was inspected by such inspectors;

(D) the number of inspectors that were licensed by each country from which any imports were received and that were assigned, during the calendar year concerned, to inspect such imports and the facilities in which such imports were handled; and the frequency and effectiveness of such inspections;

(E) the total volume of eggs and egg products which was imported into the United States during the calendar year concerned from each country, including a separate itemization of the volume of each major category of such imports from each country during such year, and a detailed report of rejections of plants and products because of failure to meet appropriate standards prescribed by this chapter; and

(F) recommendations for legislation to improve such program.

(Pub. L. 91–597, §26, Dec. 29, 1970, 84 Stat. 1634; Pub. L. 103–437, §8(4), Nov. 2, 1994, 108 Stat. 4588.)

Editorial Notes

References in Text

This chapter, referred to in subsec. (a)(1), (2)(A), (E), was in the original "this Act", meaning Pub. L. 91–597, Dec. 29, 1970, 84 Stat. 1620, which is classified principally to this chapter. For complete classification of this Act to the Code, see Short Title note set out under section 1031 of this title and Tables.

Amendments

1994—Pub. L. 103–437 substituted "Agriculture, Nutrition, and Forestry" for "Agriculture and Forestry" in introductory provisions.

Statutory Notes and Related Subsidiaries

Effective Date

For effective date of this section, see section 29 of Pub. L. 91–597, set out as a note under section 1031 of this title.

1 So in original. No subsec. (b) has been enacted.
21 U.S.C. § 2404 (2024) — Title 21: FOOD AND DRUGS / Chapter 29: INTERNATIONAL SPORTS DOPING / Section 2404: Coordination and sharing of information with USADA
Coordination and sharing of information with USADA
Status: in_force

Except as otherwise prohibited by law and except in cases in which the integrity of a criminal investigation would be affected, in furtherance of the obligation of the United States under Article 7 of the Convention, the Department of Justice, the Department of Homeland Security, and the Food and Drug Administration shall coordinate with USADA with regard to any investigation related to a potential violation of section 2402 of this title, to include sharing with USADA all information in the possession of the Department of Justice, the Department of Homeland Security, or the Food and Drug Administration which may be relevant to any such potential violation.

(Pub. L. 116–206, §6, Dec. 4, 2020, 134 Stat. 1000.)
21 U.S.C. § 204 (2024) — Title 21: FOOD AND DRUGS / Chapter 7: PRACTICE OF PHARMACY AND SALE OF POISONS IN CONSULAR DISTRICTS IN CHINA / Section 204: Issuance of license
Issuance of license
Status: in_force

If the applicant for license as a pharmacist has complied with the requirements of section 203 of this title, the consul shall issue to him a license which shall entitle him to practice pharmacy in the consular districts of the United States in China, subject to the provisions of this chapter.

(Mar. 3, 1915, ch. 74, §3, 38 Stat. 819.)
21 U.S.C. § 360c (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter V: DRUGS AND DEVICES / Section 360c: Classification of devices intended for human use
Classification of devices intended for human use
Status: in_force

(a) Classes of devices

(1) There are established the following classes of devices intended for human use:

(A) Class I, General Controls.—

(i) A device for which the controls authorized by or under section 351, 352, 360, 360f, 360h, 360i, or 360j of this title or any combination of such sections are sufficient to provide reasonable assurance of the safety and effectiveness of the device.

(ii) A device for which insufficient information exists to determine that the controls referred to in clause (i) are sufficient to provide reasonable assurance of the safety and effectiveness of the device or to establish special controls to provide such assurance, but because it—

(I) is not purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health, and

(II) does not present a potential unreasonable risk of illness or injury,

is to be regulated by the controls referred to in clause (i).

(B) Class II, Special Controls.—A device which cannot be classified as a class I device because the general controls by themselves are insufficient to provide reasonable assurance of the safety and effectiveness of the device, and for which there is sufficient information to establish special controls to provide such assurance, including the promulgation of performance standards, postmarket surveillance, patient registries, development and dissemination of guidelines (including guidelines for the submission of clinical data in premarket notification submissions in accordance with section 360(k) of this title), recommendations, and other appropriate actions as the Secretary deems necessary to provide such assurance. For a device that is purported or represented to be for a use in supporting or sustaining human life, the Secretary shall examine and identify the special controls, if any, that are necessary to provide adequate assurance of safety and effectiveness and describe how such controls provide such assurance.

(C) Class III, Premarket Approval.—A device which because—

(i) it (I) cannot be classified as a class I device because insufficient information exists to determine that the application of general controls are sufficient to provide reasonable assurance of the safety and effectiveness of the device, and (II) cannot be classified as a class II device because insufficient information exists to determine that the special controls described in subparagraph (B) would provide reasonable assurance of its safety and effectiveness, and

(ii)(I) is purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health, or

(II) presents a potential unreasonable risk of illness or injury,

is to be subject, in accordance with section 360e of this title, to premarket approval to provide reasonable assurance of its safety and effectiveness.

If there is not sufficient information to establish a performance standard for a device to provide reasonable assurance of its safety and effectiveness, the Secretary may conduct such activities as may be necessary to develop or obtain such information.

(2) For purposes of this section and sections 360d and 360e of this title, the safety and effectiveness of a device are to be determined—

(A) with respect to the persons for whose use the device is represented or intended,

(B) with respect to the conditions of use prescribed, recommended, or suggested in the labeling of the device, and

(C) weighing any probable benefit to health from the use of the device against any probable risk of injury or illness from such use.

(3)(A) Except as authorized by subparagraph (B), the effectiveness of a device is, for purposes of this section and sections 360d and 360e of this title, to be determined, in accordance with regulations promulgated by the Secretary, on the basis of well-controlled investigations, including 1 or more clinical investigations where appropriate, by experts qualified by training and experience to evaluate the effectiveness of the device, from which investigations it can fairly and responsibly be concluded by qualified experts that the device will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling of the device.

(B) If the Secretary determines that there exists valid scientific evidence (other than evidence derived from investigations described in subparagraph (A))—

(i) which is sufficient to determine the effectiveness of a device, and

(ii) from which it can fairly and responsibly be concluded by qualified experts that the device will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling of the device,

then, for purposes of this section and sections 360d and 360e of this title, the Secretary may authorize the effectiveness of the device to be determined on the basis of such evidence.

(C) In making a determination of a reasonable assurance of the effectiveness of a device for which an application under section 360e of this title has been submitted, the Secretary shall consider whether the extent of data that otherwise would be required for approval of the application with respect to effectiveness can be reduced through reliance on postmarket controls.

(D)(i) The Secretary, upon the written request of any person intending to submit an application under section 360e of this title, shall meet with such person to determine the type of valid scientific evidence (within the meaning of subparagraphs (A) and (B)) that will be necessary to demonstrate for purposes of approval of an application the effectiveness of a device for the conditions of use proposed by such person. The written request shall include a detailed description of the device, a detailed description of the proposed conditions of use of the device, a proposed plan for determining whether there is a reasonable assurance of effectiveness, and, if available, information regarding the expected performance from the device. Within 30 days after such meeting, the Secretary shall specify in writing the type of valid scientific evidence that will provide a reasonable assurance that a device is effective under the conditions of use proposed by such person.

(ii) Any clinical data, including one or more well-controlled investigations, specified in writing by the Secretary for demonstrating a reasonable assurance of device effectiveness shall be specified as result of a determination by the Secretary that such data are necessary to establish device effectiveness. The Secretary shall consider, in consultation with the applicant, the least burdensome appropriate means of evaluating device effectiveness that would have a reasonable likelihood of resulting in approval.

(iii) For purposes of clause (ii), the term "necessary" means the minimum required information that would support a determination by the Secretary that an application provides reasonable assurance of the effectiveness of the device.

(iv) Nothing in this subparagraph shall alter the criteria for evaluating an application for premarket approval of a device.

(v) The determination of the Secretary with respect to the specification of valid scientific evidence under clauses (i) and (ii) shall be binding upon the Secretary, unless such determination by the Secretary could be contrary to the public health.

(b) Classification panels

(1) For purposes of—

(A) determining which devices intended for human use should be subject to the requirements of general controls, performance standards, or premarket approval, and

(B) providing notice to the manufacturers and importers of such devices to enable them to prepare for the application of such requirements to devices manufactured or imported by them,

the Secretary shall classify all such devices (other than devices classified by subsection (f)) into the classes established by subsection (a). For the purpose of securing recommendations with respect to the classification of devices, the Secretary shall establish panels of experts or use panels of experts established before May 28, 1976, or both. Section 1013 of title 5 shall not apply to the duration of a panel established under this paragraph.

(2) The Secretary shall appoint to each panel established under paragraph (1) persons who are qualified by training and experience to evaluate the safety and effectiveness of the devices to be referred to the panel and who, to the extent feasible, possess skill in the use of, or experience in the development, manufacture, or utilization of, such devices. The Secretary shall make appointments to each panel so that each panel shall consist of members with adequately diversified expertise in such fields as clinical and administrative medicine, engineering, biological and physical sciences, and other related professions. In addition, each panel shall include as nonvoting members a representative of consumer interests and a representative of interests of the device manufacturing industry. Scientific, trade, and consumer organizations shall be afforded an opportunity to nominate individuals for appointment to the panels. No individual who is in the regular full-time employ of the United States and engaged in the administration of this chapter may be a member of any panel. The Secretary shall designate one of the members of each panel to serve as chairman thereof.

(3) Panel members (other than officers or employees of the United States), while attending meetings or conferences of a panel or otherwise engaged in its business, shall be entitled to receive compensation at rates to be fixed by the Secretary, but not at rates exceeding the daily equivalent of the rate in effect for grade GS–18 of the General Schedule, for each day so engaged, including traveltime; and while so serving away from their homes or regular places of business each member may be allowed travel expenses (including per diem in lieu of subsistence) as authorized by section 5703 of title 5, for persons in the Government service employed intermittently.

(4) The Secretary shall furnish each panel with adequate clerical and other necessary assistance.

(5)(A) Classification panels covering each type of device shall be scheduled to meet at such times as may be appropriate for the Secretary to meet applicable statutory deadlines.

(B) When a device is specifically the subject of review by a classification panel, the Secretary shall—

(i) ensure that adequate expertise is represented on the classification panel to assess—

(I) the disease or condition which the device is intended to cure, treat, mitigate, prevent, or diagnose; and

(II) the technology of the device; and

(ii) provide an opportunity for the person whose device is specifically the subject of panel review to provide recommendations on the expertise needed among the voting members of the panel.

(C) For purposes of subparagraph (B)(i), the term "adequate expertise" means that the membership of the classification panel includes—

(i) two or more voting members, with a specialty or other expertise clinically relevant to the device under review; and

(ii) at least one voting member who is knowledgeable about the technology of the device.

(D) The Secretary shall provide an annual opportunity for patients, representatives of patients, and sponsors of medical devices that may be specifically the subject of a review by a classification panel to provide recommendations for individuals with appropriate expertise to fill voting member positions on classification panels.

(6)(A) Any person whose device is specifically the subject of review by a classification panel shall have—

(i) the same access to data and information submitted to a classification panel (except for data and information that are not available for public disclosure under section 552 of title 5) as the Secretary;

(ii) the opportunity to submit, for review by a classification panel, information that is based on the data or information provided in the application submitted under section 360e of this title by the person, which information shall be submitted to the Secretary for prompt transmittal to the classification panel; and

(iii) the same opportunity as the Secretary to participate in meetings of the panel, including, subject to the discretion of the panel chairperson, by designating a representative who will be provided a time during the panel meeting to address the panel for the purpose of correcting misstatements of fact or providing clarifying information, and permitting the person or representative to call on experts within the person's organization to address such specific issues in the time provided.

(B)(i) Any meeting of a classification panel with respect to the review of a device shall—

(I) provide adequate time for initial presentations by the person whose device is specifically the subject of such review and by the Secretary; and

(II) encourage free and open participation by all interested persons.

(ii) Following the initial presentations described in clause (i), the panel may—

(I) pose questions to a designated representative described in subparagraph (A)(iii); and

(II) consider the responses to such questions in the panel's review of the device.

(7) After receiving from a classification panel the conclusions and recommendations of the panel on a matter that the panel has reviewed, the Secretary shall review the conclusions and recommendations, shall make a final decision on the matter in accordance with section 360e(d)(2) of this title, and shall notify the affected persons of the decision in writing and, if the decision differs from the conclusions and recommendations of the panel, shall include the reasons for the difference.

(8) A classification panel under this subsection shall not be subject to the annual chartering and annual report requirements of the 1 chapter 10 of title 5.

(c) Classification panel organization and operation

(1) The Secretary shall organize the panels according to the various fields of clinical medicine and fundamental sciences in which devices intended for human use are used. The Secretary shall refer a device to be classified under this section to an appropriate panel established or authorized to be used under subsection (b) for its review and for its recommendation respecting the classification of the device. The Secretary shall by regulation prescribe the procedure to be followed by the panels in making their reviews and recommendations. In making their reviews of devices, the panels, to the maximum extent practicable, shall provide an opportunity for interested persons to submit data and views on the classification of the devices.

(2)(A) Upon completion of a panel's review of a device referred to it under paragraph (1), the panel shall, subject to subparagraphs (B) and (C), submit to the Secretary its recommendation for the classification of the device. Any such recommendation shall (i) contain (I) a summary of the reasons for the recommendation, (II) a summary of the data upon which the recommendation is based, and (III) an identification of the risks to health (if any) presented by the device with respect to which the recommendation is made, and (ii) to the extent practicable, include a recommendation for the assignment of a priority for the application of the requirements of section 360d or 360e of this title to a device recommended to be classified in class II or class III.

(B) A recommendation of a panel for the classification of a device in class I shall include a recommendation as to whether the device should be exempted from the requirements of section 360, 360i, or 360j(f) of this title.

(C) In the case of a device which has been referred under paragraph (1) to a panel, and which—

(i) is intended to be implanted in the human body or is purported or represented to be for a use in supporting or sustaining human life, and

(ii)(I) has been introduced or delivered for introduction into interstate commerce for commercial distribution before May 28, 1976, or

(II) is within a type of device which was so introduced or delivered before such date and is substantially equivalent to another device within that type,

such panel shall recommend to the Secretary that the device be classified in class III unless the panel determines that classification of the device in such class is not necessary to provide reasonable assurance of its safety and effectiveness. If a panel does not recommend that such a device be classified in class III, it shall in its recommendation to the Secretary for the classification of the device set forth the reasons for not recommending classification of the device in such class.

(3) The panels shall submit to the Secretary within one year of the date funds are first appropriated for the implementation of this section their recommendations respecting all devices of a type introduced or delivered for introduction into interstate commerce for commercial distribution before May 28, 1976.

(d) Panel recommendation; publication; priorities

(1) Upon receipt of a recommendation from a panel respecting a device, the Secretary shall publish in the Federal Register the panel's recommendation and a proposed regulation classifying such device and shall provide interested persons an opportunity to submit comments on such recommendation and the proposed regulation. After reviewing such comments, the Secretary shall, subject to paragraph (2), by regulation classify such device.

(2)(A) A regulation under paragraph (1) classifying a device in class I shall prescribe which, if any, of the requirements of section 360, 360i, or 360j(f) of this title shall not apply to the device. A regulation which makes a requirement of section 360, 360i, or 360j(f) of this title inapplicable to a device shall be accompanied by a statement of the reasons of the Secretary for making such requirement inapplicable.

(B) A device described in subsection (c)(2)(C) shall be classified in class III unless the Secretary determines that classification of the device in such class is not necessary to provide reasonable assurance of its safety and effectiveness. A proposed regulation under paragraph (1) classifying such a device in a class other than class III shall be accompanied by a full statement of the reasons of the Secretary (and supporting documentation and data) for not classifying such device in such class and an identification of the risks to health (if any) presented by such device.

(3) In the case of devices classified in class II and devices classified under this subsection in class III and described in section 360e(b)(1) of this title the Secretary may establish priorities which, in his discretion, shall be used in applying sections 360d and 360e of this title, as appropriate, to such devices.

(e) Classification changes

(1)(A)(i) Based on new information respecting a device, the Secretary may, upon the initiative of the Secretary or upon petition of an interested person, change the classification of such device, and revoke, on account of the change in classification, any regulation or requirement in effect under section 360d or 360e of this title with respect to such device, by administrative order published in the Federal Register following publication of a proposed reclassification order in the Federal Register, a meeting of a device classification panel described in subsection (b), and consideration of comments to a public docket, notwithstanding subchapter II of chapter 5 of title 5. The proposed reclassification order published in the Federal Register shall set forth the proposed reclassification, and a substantive summary of the valid scientific evidence concerning the proposed reclassification, including—

(I) the public health benefit of the use of the device, and the nature and, if known, incidence of the risk of the device;

(II) in the case of a reclassification from class II to class III, why general controls pursuant to subsection (a)(1)(A) and special controls pursuant to subsection (a)(1)(B) together are not sufficient to provide a reasonable assurance of safety and effectiveness for such device; and

(III) in the case of reclassification from class III to class II, why general controls pursuant to subsection (a)(1)(A) and special controls pursuant to subsection (a)(1)(B) together are sufficient to provide a reasonable assurance of safety and effectiveness for such device.

(ii) An order under this subsection changing the classification of a device from class III to class II may provide that such classification shall not take effect until the effective date of a performance standard established under section 360d of this title for such device.

(B) Authority to issue such administrative order shall not be delegated below the Director of the Center for Devices and Radiological Health, acting in consultation with the Commissioner.

(2) By an order issued under paragraph (1), the Secretary may change the classification of a device from class III—

(A) to class II if the Secretary determines that special controls would provide reasonable assurance of the safety and effectiveness of the device and that general controls would not provide reasonable assurance of the safety and effectiveness of the device, or

(B) to class I if the Secretary determines that general controls would provide reasonable assurance of the safety and effectiveness of the device.

(f) Initial classification and reclassification of certain devices

(1) Any device intended for human use which was not introduced or delivered for introduction into interstate commerce for commercial distribution before May 28, 1976, is classified in class III unless—

(A) the device—

(i) is within a type of device (I) which was introduced or delivered for introduction into interstate commerce for commercial distribution before such date and which is to be classified pursuant to subsection (b), or (II) which was not so introduced or delivered before such date and has been classified in class I or II, and

(ii) is substantially equivalent to another device within such type;

(B) the Secretary in response to a petition submitted under paragraph (3) has classified such device in class I or II; or

(C) the device is classified pursuant to a request submitted under paragraph (2).

A device classified in class III under this paragraph shall be classified in that class until the effective date of an order of the Secretary under paragraph (2) or (3) classifying the device in class I or II.

(2)(A)(i) Any person who submits a report under section 360(k) of this title for a type of device that has not been previously classified under this chapter, and that is classified into class III under paragraph (1), may request, after receiving written notice of such a classification, the Secretary to classify the device.

(ii) In lieu of submitting a report under section 360(k) of this title and submitting a request for classification under clause (i) for a device, if a person determines there is no legally marketed device upon which to base a determination of substantial equivalence (as defined in subsection (i)), a person may submit a request under this clause for the Secretary to classify the device.

(iii) Upon receipt of a request under clause (i) or (ii), the Secretary shall classify the device subject to the request under the criteria set forth in subparagraphs (A) through (C) of subsection (a)(1) within 120 days.

(iv) Notwithstanding clause (iii), the Secretary may decline to undertake a classification request submitted under clause (ii) if the Secretary identifies a legally marketed device that could provide a reasonable basis for review of substantial equivalence under paragraph (1), or when the Secretary determines that the device submitted is not of low to moderate risk or that general controls would be inadequate to control the risks and special controls to mitigate the risks cannot be developed.

(v) The person submitting the request for classification under this subparagraph may recommend to the Secretary a classification for the device and shall, if recommending classification in class II, include in the request an initial draft proposal for applicable special controls, as described in subsection (a)(1)(B), that are necessary, in conjunction with general controls, to provide reasonable assurance of safety and effectiveness and a description of how the special controls provide such assurance. Any such request shall describe the device and provide detailed information and reasons for the recommended classification.

(B)(i) The Secretary shall by written order classify the device involved. Such classification shall be the initial classification of the device for purposes of paragraph (1) and any device classified under this paragraph shall be a predicate device for determining substantial equivalence under paragraph (1).

(ii) A device that remains in class III under this subparagraph shall be deemed to be adulterated within the meaning of section 351(f)(1)(B) of this title until approved under section 360e of this title or exempted from such approval under section 360j(g) of this title.

(C) Within 30 days after the issuance of an order classifying a device under this paragraph, the Secretary shall publish a notice in the Federal Register announcing such classification.

(3)(A) The Secretary may initiate the reclassification of a device classified into class III under paragraph (1) of this subsection or the manufacturer or importer of a device classified under paragraph (1) may petition the Secretary (in such form and manner as he shall prescribe) for the issuance of an order classifying the device in class I or class II. Within thirty days of the filing of such a petition, the Secretary shall notify the petitioner of any deficiencies in the petition which prevent the Secretary from making a decision on the petition.

(B)(i) Upon determining that a petition does not contain any deficiency which prevents the Secretary from making a decision on the petition, the Secretary may for good cause shown refer the petition to an appropriate panel established or authorized to be used under subsection (b). A panel to which such a petition has been referred shall not later than ninety days after the referral of the petition make a recommendation to the Secretary respecting approval or denial of the petition. Any such recommendation shall contain (I) a summary of the reasons for the recommendation, (II) a summary of the data upon which the recommendation is based, and (III) an identification of the risks to health (if any) presented by the device with respect to which the petition was filed. In the case of a petition for a device which is intended to be implanted in the human body or which is purported or represented to be for a use in supporting or sustaining human life, the panel shall recommend that the petition be denied unless the panel determines that the classification in class III of the device is not necessary to provide reasonable assurance of its safety and effectiveness. If the panel recommends that such petition be approved, it shall in its recommendation to the Secretary set forth its reasons for such recommendation.

(ii) The requirements of paragraphs (1) and (2) of subsection (c) (relating to opportunities for submission of data and views and recommendations respecting priorities and exemptions from sections 360, 360i, and 360j(f) of this title) shall apply with respect to consideration by panels of petitions submitted under subparagraph (A).

(C)(i) Within ninety days from the date the Secretary receives the recommendation of a panel respecting a petition (but not later than 210 days after the filing of such petition) the Secretary shall by order deny or approve the petition. If the Secretary approves the petition, the Secretary shall order the classification of the device into class I or class II in accordance with the criteria prescribed by subsection (a)(1)(A) or (a)(1)(B). In the case of a petition for a device which is intended to be implanted in the human body or which is purported or represented to be for a use in supporting or sustaining human life, the Secretary shall deny the petition unless the Secretary determines that the classification in class III of the device is not necessary to provide reasonable assurance of its safety and effectiveness. An order approving such petition shall be accompanied by a full statement of the reasons of the Secretary (and supporting documentation and data) for approving the petition and an identification of the risks to health (if any) presented by the device to which such order applies.

(ii) The requirements of paragraphs (1) and (2)(A) of subsection (d) (relating to publication of recommendations, opportunity for submission of comments, and exemption from sections 360, 360i, and 360j(f) of this title) shall apply with respect to action by the Secretary on petitions submitted under subparagraph (A).

(4) If a manufacturer reports to the Secretary under section 360(k) of this title that a device is substantially equivalent to another device—

(A) which the Secretary has classified as a class III device under subsection (b),

(B) which was introduced or delivered for introduction into interstate commerce for commercial distribution before December 1, 1990, and

(C) for which no final regulation requiring premarket approval has been promulgated under section 360e(b) of this title,

the manufacturer shall certify to the Secretary that the manufacturer has conducted a reasonable search of all information known or otherwise available to the manufacturer respecting such other device and has included in the report under section 360(k) of this title a summary of and a citation to all adverse safety and effectiveness data respecting such other device and respecting the device for which the section 360(k) report is being made and which has not been submitted to the Secretary under section 360i of this title. The Secretary may require the manufacturer to submit the adverse safety and effectiveness data described in the report.

(5) The Secretary may not withhold a determination of the initial classification of a device under paragraph (1) because of a failure to comply with any provision of this chapter unrelated to a substantial equivalence decision, including a finding that the facility in which the device is manufactured is not in compliance with good manufacturing requirements as set forth in regulations of the Secretary under section 360j(f) of this title (other than a finding that there is a substantial likelihood that the failure to comply with such regulations will potentially present a serious risk to human health).

(6)(A) Subject to the succeeding subparagraphs of this paragraph, the Secretary shall, by written order, classify an accessory under this section based on the risks of the accessory when used as intended and the level of regulatory controls necessary to provide a reasonable assurance of safety and effectiveness of the accessory, notwithstanding the classification of any other device with which such accessory is intended to be used.

(B) The classification of any accessory distinct from another device by regulation or written order issued prior to December 13, 2016, shall continue to apply unless and until the accessory is reclassified by the Secretary, notwithstanding the classification of any other device with which such accessory is intended to be used. Nothing in this paragraph shall preclude the Secretary's authority to initiate the classification of an accessory through regulation or written order, as appropriate.

(C)(i) In the case of a device intended to be used with an accessory, where the accessory has been included in an application for premarket approval of such device under section 360e of this title or a report under section 360(k) of this title for clearance of such device and the Secretary has not classified such accessory distinctly from another device in accordance with subparagraph (A), the person filing the application or report (as applicable) at the time such application or report is filed—

(I) may include a written request for the proper classification of the accessory pursuant to subparagraph (A);

(II) shall include in any such request such information as may be necessary for the Secretary to evaluate, based on the least burdensome approach, the appropriate class for the accessory under subsection (a); and

(III) shall, if the request under subclause (I) is requesting classification of the accessory in class II, include in the application an initial draft proposal for special controls, if special controls would be required pursuant to subsection (a)(1)(B).

(ii) The Secretary's response under section 360e(d) or section 360(n) of this title (as applicable) to an application or report described in clause (i) shall also contain the Secretary's granting or denial of the request for classification of the accessory involved.

(iii) The Secretary's evaluation of an accessory under clause (i) shall constitute an order establishing a new classification for such accessory for the specified intended use or uses of such accessory and for any accessory with the same intended use or uses as such accessory.

(D) For accessories that have been granted marketing authorization as part of a submission for another device with which the accessory involved is intended to be used, through an application for such other device under section 360e(c) of this title, a report under section 360(k) of this title, or a request for classification under paragraph (2) of this subsection, the following shall apply:

(i) Not later than the date that is one year after August 18, 2017, and at least once every 5 years thereafter, and as the Secretary otherwise determines appropriate, pursuant to this paragraph, the Secretary shall publish in the Federal Register a notice proposing a list of such accessories that the Secretary determines may be suitable for a distinct classification in class I and the proposed regulations for such classifications. In developing such list, the Secretary shall consider recommendations from sponsors of device submissions and other stakeholders for accessories to be included on such list. The notices shall provide for a period of not less than 60 calendar days for public comment. Within 180 days after the end of the comment period, the Secretary shall publish in the Federal Register a final action classifying such suitable accessories into class I.

(ii) A manufacturer or importer of an accessory that has been granted such marketing authorization may submit to the Secretary a written request for the appropriate classification of the accessory based on the risks and appropriate level of regulatory controls as described in subparagraph (A), and shall, if the request is requesting classification of the accessory in class II, include in the submission an initial draft proposal for special controls, if special controls would be required pursuant to subsection (a)(1)(B). Such request shall include such information as may be necessary for the Secretary to evaluate, based on the least burdensome approach, the appropriate class for the accessory under subsection (a). The Secretary shall provide an opportunity for a manufacturer or importer to meet with appropriate personnel of the Food and Drug Administration to discuss the appropriate classification of such accessory prior to submitting a written request under this clause for classification of the accessory.

(iii) The Secretary shall respond to a request made under clause (ii) not later than 85 calendar days after receiving such request by issuing a written order classifying the accessory or denying the request. If the Secretary does not agree with the recommendation for classification submitted by the manufacturer or importer, the response shall include a detailed description and justification for such determination. Within 30 calendar days after granting such a request, the Secretary shall publish a notice in the Federal Register announcing such response.

(E) Nothing in this paragraph may be construed as precluding a manufacturer of an accessory of a new type from using the classification process described in subsection (f)(2) to obtain classification of such accessory in accordance with the criteria and requirements set forth in that subsection.

(g) Information

Within sixty days of the receipt of a written request of any person for information respecting the class in which a device has been classified or the requirements applicable to a device under this chapter, the Secretary shall provide such person a written statement of the classification (if any) of such device and the requirements of this chapter applicable to the device.

(h) Definitions

For purposes of this section and sections 351, 360, 360d, 360e, 360f, 360i, and 360j of this title

(1) a reference to "general controls" is a reference to the controls authorized by or under sections 351, 352, 360, 360f, 360h, 360i, and 360j of this title,

(2) a reference to "class I", "class II", or "class III" is a reference to a class of medical devices described in subparagraph (A), (B), or (C) of subsection (a)(1), and

(3) a reference to a "panel under section 360c of this title" is a reference to a panel established or authorized to be used under this section.

(i) Substantial equivalence

(1)(A) For purposes of determinations of substantial equivalence under subsection (f) and section 360j(l) of this title, the term "substantially equivalent" or "substantial equivalence" means, with respect to a device being compared to a predicate device, that the device has the same intended use as the predicate device and that the Secretary by order has found that the device—

(i) has the same technological characteristics as the predicate device, or

(ii)(I) has different technological characteristics and the information submitted that the device is substantially equivalent to the predicate device contains information, including appropriate clinical or scientific data if deemed necessary by the Secretary or a person accredited under section 360m of this title, that demonstrates that the device is as safe and effective as a legally marketed device, and (II) does not raise different questions of safety and effectiveness than the predicate device.

(B) For purposes of subparagraph (A), the term "different technological characteristics" means, with respect to a device being compared to a predicate device, that there is a significant change in the materials, design, energy source, or other features of the device from those of the predicate device.

(C) To facilitate reviews of reports submitted to the Secretary under section 360(k) of this title, the Secretary shall consider the extent to which reliance on postmarket controls may expedite the classification of devices under subsection (f)(1) of this section.

(D)(i) Whenever the Secretary requests information to demonstrate that devices with differing technological characteristics are substantially equivalent, the Secretary shall only request information that is necessary to making substantial equivalence determinations. In making such request, the Secretary shall consider the least burdensome means of demonstrating substantial equivalence and request information accordingly.

(ii) For purposes of clause (i), the term "necessary" means the minimum required information that would support a determination of substantial equivalence between a new device and a predicate device.

(iii) Nothing in this subparagraph shall alter the standard for determining substantial equivalence between a new device and a predicate device.

(E)(i) Any determination by the Secretary of the intended use of a device shall be based upon the proposed labeling submitted in a report for the device under section 360(k) of this title. However, when determining that a device can be found substantially equivalent to a legally marketed device, the director of the organizational unit responsible for regulating devices (in this subparagraph referred to as the "Director") may require a statement in labeling that provides appropriate information regarding a use of the device not identified in the proposed labeling if, after providing an opportunity for consultation with the person who submitted such report, the Director determines and states in writing—

(I) that there is a reasonable likelihood that the device will be used for an intended use not identified in the proposed labeling for the device; and

(II) that such use could cause harm.

(ii) Such determination shall—

(I) be provided to the person who submitted the report within 10 days from the date of the notification of the Director's concerns regarding the proposed labeling;

(II) specify the limitations on the use of the device not included in the proposed labeling; and

(III) find the device substantially equivalent if the requirements of subparagraph (A) are met and if the labeling for such device conforms to the limitations specified in subclause (II).

(iii) The responsibilities of the Director under this subparagraph may not be delegated.

(F) Not later than 270 days after November 21, 1997, the Secretary shall issue guidance specifying the general principles that the Secretary will consider in determining when a specific intended use of a device is not reasonably included within a general use of such device for purposes of a determination of substantial equivalence under subsection (f) or section 360j(l) of this title.

(2) A device may not be found to be substantially equivalent to a predicate device that has been removed from the market at the initiative of the Secretary or that has been determined to be misbranded or adulterated by a judicial order.

(3)(A) As part of a submission under section 360(k) of this title respecting a device, the person required to file a premarket notification under such section shall provide an adequate summary of any information respecting safety and effectiveness or state that such information will be made available upon request by any person.

(B) Any summary under subparagraph (A) respecting a device shall contain detailed information regarding data concerning adverse health effects and shall be made available to the public by the Secretary within 30 days of the issuance of a determination that such device is substantially equivalent to another device.

(j) Training and oversight of least burdensome requirements

(1) The Secretary shall—

(A) ensure that each employee of the Food and Drug Administration who is involved in the review of premarket submissions, including supervisors, receives training regarding the meaning and implementation of the least burdensome requirements under subsections (a)(3)(D) and (i)(1)(D) of this section and section 360e(c)(5) of this title; and

(B) periodically assess the implementation of the least burdensome requirements, including the employee training under subparagraph (A), to ensure that the least burdensome requirements are fully and consistently applied.

(2) Not later than 18 months after December 13, 2016, the ombudsman for any organizational unit of the Food and Drug Administration responsible for the premarket review of devices shall—

(A) conduct an audit of the training described in paragraph (1)(A), including the effectiveness of such training in implementing the least burdensome requirements;

(B) include in such audit interviews of persons who are representatives of the device industry regarding their experiences in the device premarket review process, including with respect to the application of least burdensome concepts to premarket review and decisionmaking;

(C) include in such audit a list of the measurement tools the Secretary uses to assess the implementation of the least burdensome requirements, including under paragraph (1)(B) and section 360g–1(a)(3) of this title, and may also provide feedback on the effectiveness of such tools in the implementation of the least burdensome requirements;

(D) summarize the findings of such audit in a final audit report; and

(E) within 30 calendar days of completion of such final audit report, make such final audit report available—

(i) to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives; and

(ii) on the Internet website of the Food and Drug Administration.

(k) Dual submission for certain devices

For a device authorized for emergency use under section 360bbb–3 of this title for which, in accordance with section 360bbb–3(m) of this title, the Secretary has deemed a laboratory examination or procedure associated with such device to be in the category of examinations and procedures described in section 263a(d)(3) of title 42, the sponsor of such device may, when submitting a request for classification under subsection (f)(2), submit a single submission containing—

(1) the information needed for such a request; and

(2) sufficient information to enable the Secretary to determine whether such laboratory examination or procedure satisfies the criteria to be categorized under section 263a(d)(3) of title 42.

(June 25, 1938, ch. 675, §513, as added Pub. L. 94–295, §2, May 28, 1976, 90 Stat. 540; amended Pub. L. 101–629, §§4(a), 5(a)–(c)(1), (3), 12(a), 18(a), Nov. 28, 1990, 104 Stat. 4515, 4517, 4518, 4523, 4528; Pub. L. 102–300, §6(e), June 16, 1992, 106 Stat. 240; Pub. L. 103–80, §3(s), Aug. 13, 1993, 107 Stat. 778; Pub. L. 105–115, title II, §§205(a), (b), 206(b), (c), 207, 208, 217, Nov. 21, 1997, 111 Stat. 2336, 2337, 2339, 2340, 2350; Pub. L. 107–250, title II, §208, Oct. 26, 2002, 116 Stat. 1613; Pub. L. 112–144, title VI, §§602, 607–608(a)(2)(A), July 9, 2012, 126 Stat. 1051, 1054–1056; Pub. L. 114–255, div. A, title III, §§3055, 3058(a), 3060(c), 3101(a)(2)(I), Dec. 13, 2016, 130 Stat. 1127, 1128, 1133, 1154; Pub. L. 115–52, title VII, §707(a), (b), title IX, §901(h), Aug. 18, 2017, 131 Stat. 1060, 1062, 1077; Pub. L. 117–286, §4(a)(155), Dec. 27, 2022, 136 Stat. 4323; Pub. L. 117–328, div. FF, title III, §3301, Dec. 29, 2022, 136 Stat. 5831.)

Editorial Notes

Amendments

2022—Subsec. (b)(1). Pub. L. 117–286, §4(a)(155)(A), substituted "Section 1013 of title 5" for "Section 14 of the Federal Advisory Committee Act" in concluding provisions.

Subsec. (b)(8). Pub. L. 117–286, §4(a)(155)(B), substituted "chapter 10 of title 5." for "Federal Advisory Committee Act."

Subsec. (k). Pub. L. 117–328 added subsec. (k).

2017—Subsec. (b)(5)(D). Pub. L. 115–52, §901(h), substituted "medical devices that may be specifically the subject of a review by a classification panel" for "medical device submissions".

Subsec. (b)(9). Pub. L. 115–52, §707(b), struck out par. (9) which read as follows: "The Secretary shall classify an accessory under this section based on the intended use of the accessory, notwithstanding the classification of any other device with which such accessory is intended to be used."

Subsec. (f)(6). Pub. L. 115–52, §707(a), added par. (6).

2016—Subsec. (b)(5). Pub. L. 114–255, §3055(a), designated existing provisions as subpar. (A) and added subpars. (B) to (D).

Subsec. (b)(6)(A)(iii). Pub. L. 114–255, §3055(b)(1), inserted before period at end ", including, subject to the discretion of the panel chairperson, by designating a representative who will be provided a time during the panel meeting to address the panel for the purpose of correcting misstatements of fact or providing clarifying information, and permitting the person or representative to call on experts within the person's organization to address such specific issues in the time provided".

Subsec. (b)(6)(B). Pub. L. 114–255, §3055(b)(2), added subpar. (B) and struck out former subpar. (B) which read as follows: "Any meetings of a classification panel shall provide adequate time for initial presentations and for response to any differing views by persons whose devices are specifically the subject of a classification panel review, and shall encourage free and open participation by all interested persons."

Subsec. (b)(9). Pub. L. 114–255, §3060(c), added par. (9).

Subsec. (f)(2)(A)(i). Pub. L. 114–255, §3101(a)(2)(I)(i), struck out "within 30 days" after "may request,".

Subsec. (f)(2)(A)(iv). Pub. L. 114–255, §3101(a)(2)(I)(ii), substituted "low to moderate" for "low-moderate".

Subsec. (j). Pub. L. 114–255, §3058(a), added subsec. (j).

2012—Subsec. (a)(3)(D)(iii) to (v). Pub. L. 112–144, §602(a), added cls. (iii) and (iv) and redesignated former cl. (iii) as (v).

Subsec. (e)(1). Pub. L. 112–144, §608(a)(1), amended par. (1) generally. Prior to amendment, par. (1) read as follows: "Based on new information respecting a device, the Secretary may, upon his own initiative or upon petition of an interested person, by regulation (A) change such device's classification, and (B) revoke, because of the change in classification, any regulation or requirement in effect under section 360d or 360e of this title with respect to such device. In the promulgation of such a regulation respecting a device's classification, the Secretary may secure from the panel to which the device was last referred pursuant to subsection (c) of this section a recommendation respecting the proposed change in the device's classification and shall publish in the Federal Register any recommendation submitted to the Secretary by the panel respecting such change. A regulation under this subsection changing the classification of a device from class III to class II may provide that such classification shall not take effect until the effective date of a performance standard established under section 360d of this title for such device."

Subsec. (e)(2). Pub. L. 112–144, §608(a)(2)(A), substituted "an order issued" for "regulation promulgated" in introductory provisions.

Subsec. (f)(1)(C). Pub. L. 112–144, §607(b), added subpar. (C).

Subsec. (f)(2)(A). Pub. L. 112–144, §607(a)(1)–(3), designated existing provisions as cl. (i), struck out "under the criteria set forth in subparagraphs (A) through (C) of subsection (a)(1) of this section. The person may, in the request, recommend to the Secretary a classification for the device. Any such request shall describe the device and provide detailed information and reasons for the recommended classification" before period at end, and added cls. (ii) to (v).

Subsec. (f)(2)(B)(i). Pub. L. 112–144, §607(a)(4), substituted "The Secretary" for "Not later than 60 days after the date of the submission of the request under subparagraph (A), the Secretary".

Subsec. (i)(1)(D). Pub. L. 112–144, §602(b), designated existing provisions as cl. (i) and added cls. (ii) and (iii).

2002—Subsec. (i)(1)(E)(iv). Pub. L. 107–250 struck out cl. (iv) which read as follows: "This subparagraph has no legal effect after the expiration of the five-year period beginning on November 21, 1997."

1997—Subsec. (a)(3)(A). Pub. L. 105–115, §217, substituted "1 or more clinical investigations" for "clinical investigations".

Subsec. (a)(3)(C), (D). Pub. L. 105–115, §205(a), added subpars. (C) and (D).

Subsec. (b)(5) to (8). Pub. L. 105–115, §208, added pars. (5) to (8).

Subsec. (f)(1). Pub. L. 105–115, §207(1)(B), substituted "paragraph (2) or (3)" for "paragraph (2)" in closing provisions.

Subsec. (f)(1)(B). Pub. L. 105–115, §207(1)(A), substituted "paragraph (3)" for "paragraph (2)".

Subsec. (f)(2) to (4). Pub. L. 105–115, §207(2), (3), added par. (2) and redesignated former pars. (2) and (3) as (3) and (4), respectively.

Subsec. (f)(5). Pub. L. 105–115, §206(b), added par. (5).

Subsec. (i)(1)(A)(ii). Pub. L. 105–115, §206(c)(1), substituted "appropriate clinical or scientific data" for "clinical data", inserted "or a person accredited under section 360m of this title" after "Secretary", and substituted "effectiveness" for "efficacy".

Subsec. (i)(1)(C) to (E). Pub. L. 105–115, §205(b), added subpars. (C) to (E).

Subsec. (i)(1)(F). Pub. L. 105–115, §206(c)(2), added subpar. (F).

1993—Subsec. (b)(3). Pub. L. 103–80 substituted "5703" for "5703(b)".

1992—Subsec. (f)(3). Pub. L. 102–300 redesignated clauses (i) to (iii) as subpars. (A) to (C), respectively, and substituted "the section 360(k) report" for "the 360(k) report" in closing provisions.

1990—Subsec. (a)(1)(A)(ii). Pub. L. 101–629, §5(a)(1), substituted "or to establish special controls" for "or to establish a performance standard".

Subsec. (a)(1)(B). Pub. L. 101–629, §5(a)(2), amended subpar. (B) generally. Prior to amendment, subpar. (B) read as follows: "Class II, Performance Standards.—A device which cannot be classified as a class I device because the controls authorized by or under sections 351, 352, 360, 360f, 360h, 360i, and 360j of this title by themselves are insufficient to provide reasonable assurance of the safety and effectiveness of the device, for which there is sufficient information to establish a performance standard to provide such assurance, and for which it is therefore necessary to establish for the device a performance standard under section 360d of this title to provide reasonable assurance of its safety and effectiveness."

Subsec. (a)(1)(C)(i). Pub. L. 101–629, §5(a)(3), amended cl. (i) generally. Prior to amendment, cl. (i) read as follows: "it (I) cannot be classified as a class I device because insufficient information exists to determine that the controls authorized by or under sections 351, 352, 360, 360f, 360h, 360i, and 360j of this title are sufficient to provide reasonable assurance of the safety and effectiveness of the device and (II) cannot be classified as a class II device because insufficient information exists for the establishment of a performance standard to provide reasonable assurance of its safety and effectiveness, and".

Subsec. (e). Pub. L. 101–629, §5(b), designated existing provisions as par. (1), redesignated cls. (1) and (2) as (A) and (B), respectively, and added par. (2).

Subsec. (f). Pub. L. 101–629, §5(c)(3), inserted "and reclassification" before "of" in heading.

Subsec. (f)(2)(A). Pub. L. 101–629, §5(c)(1), substituted "The Secretary may initiate the reclassification of a device classified into class III under paragraph (1) of this subsection or the manufacturer" for "The manufacturer".

Subsec. (f)(2)(B)(i). Pub. L. 101–629, §18(a), substituted "the Secretary may for good cause shown" for "the Secretary shall".

Subsec. (f)(3). Pub. L. 101–629, §4(a), added par. (3).

Subsec. (i). Pub. L. 101–629, §12(a), added subsec. (i).

Statutory Notes and Related Subsidiaries

Effective Date of 2017 Amendment

Pub. L. 115–52, title VII, §707(c), Aug. 18, 2017, 131 Stat. 1062, provided that: "The amendments made by subsections (a) and (b) [amending this section] shall take effect on the date that is 60 days after the date of enactment of this Act [Aug. 18, 2017]."

Effective Date of 1997 Amendment

Amendment by Pub. L. 105–115 effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as a note under section 321 of this title.

Short Title of 1976 Amendment

Pub. L. 94–295, §1(a), May 28, 1976, 90 Stat. 539, provided that: "This Act [enacting sections 360c to 360k, 379, and 379a of this title and section 3512 of Title 42, The Public Health and Welfare, and amending sections 321, 331, 334, 351, 352, 358, 360, 374, 379e, and 381 of this title and section 55 of Title 15, Commerce and Trade] may be cited as the 'Medical Device Amendments of 1976'."

Regulations

Pub. L. 101–629, §12(b), Nov. 28, 1990, 104 Stat. 4524, provided that: "Within 12 months of the date of the enactment of this Act [Nov. 28, 1990], the Secretary of Health and Human Services shall issue regulations establishing the requirements of the summaries under section 513(i)(3) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360c(i)(3)], as added by the amendment made by subsection (a)."

Devices Reclassified Prior to July 9, 2012

Pub. L. 112–144, title VI, §608(a)(3), July 9, 2012, 126 Stat. 1056, provided that:

"(A) In general.—The amendments made by this subsection [amending this section and sections 360d and 360g of this title] shall have no effect on a regulation promulgated with respect to the classification of a device under section 513(e) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360c(e)] prior to the date of enactment of this Act [July 9, 2012].

"(B) Applicability of other provisions.—In the case of a device reclassified under section 513(e) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360c(e)] by regulation prior to the date of enactment of this Act [July 9, 2012], section 517(a)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360g(a)(1)) shall apply to such regulation promulgated under section 513(e) of such Act with respect to such device in the same manner such section 517(a)(1) applies to an administrative order issued with respect to a device reclassified after the date of enactment of this Act."

Daily Wear Soft or Daily Wear Nonhydrophilic Plastic Contact Lenses

Pub. L. 101–629, §4(b)(3), Nov. 28, 1990, 104 Stat. 4517, provided that:

"(A) Notwithstanding section 520(l)(5) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360j(l)(5)], the Secretary of Health and Human Services shall not retain any daily wear soft or daily wear nonhydrophilic plastic contact lens in class III under such Act [this chapter] unless the Secretary finds that it meets the criteria set forth in section 513(a)(1)(C) of such Act [21 U.S.C. 360c(a)(1)(C)]. The finding and the grounds for the finding shall be published in the Federal Register. For any such lens, the Secretary shall make the determination respecting reclassification required in section 520(l)(5)(B) of such Act within 24 months of the date of the enactment of this paragraph [Nov. 28, 1990].

"(B) The Secretary of Health and Human Services may by notice published in the Federal Register extend the two-year period prescribed by subparagraph (A) for a lens for an additional period not to exceed one year.

"(C)(i) Before classifying a lens in class II pursuant to subparagraph (A), the Secretary of Health and Human Services shall pursuant to section 513(a)(1)(B) of such Act assure that appropriate regulatory safeguards are in effect which provide reasonable assurance of the safety and effectiveness of such lens, including clinical and preclinical data if deemed necessary by the Secretary.

"(ii) Prior to classifying a lens in class I pursuant to subparagraph (A), the Secretary shall assure that appropriate regulatory safeguards are in effect which provide reasonable assurance of the safety and effectiveness of such lens, including clinical and preclinical data if deemed necessary by the Secretary.

"(D) Notwithstanding section 520(l)(5) of such Act, if the Secretary of Health and Human Services has not made the finding and published the finding required by subparagraph (A) within 36 months of the date of the enactment of this subparagraph [Nov. 28, 1990], the Secretary shall issue an order placing the lens in class II.

"(E) Any person adversely affected by a final regulation under this paragraph revising the classification of a lens may challenge the revision of the classification of such lens only by filing a petition under section 513(e) for a classification change."

References in Other Laws to GS–16, 17, or 18 Pay Rates

References in laws to the rates of pay for GS–16, 17, or 18, or to maximum rates of pay under the General Schedule, to be considered references to rates payable under specified sections of Title 5, Government Organization and Employees, see section 529 [title I, §101(c)(1)] of Pub. L. 101–509, set out in a note under section 5376 of Title 5.

1 So in original. The word "the" probably should not appear.
21 U.S.C. § 342 (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter IV: FOOD / Section 342: Adulterated food
Adulterated food
Status: in_force

A food shall be deemed to be adulterated—

(a) Poisonous, insanitary, etc., ingredients

(1) If it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance such food shall not be considered adulterated under this clause if the quantity of such substance in such food does not ordinarily render it injurious to health.1 (2)(A) if it bears or contains any added poisonous or added deleterious substance (other than a substance that is a pesticide chemical residue in or on a raw agricultural commodity or processed food, a food additive, a color additive, or a new animal drug) that is unsafe within the meaning of section 346 of this title; or (B) if it bears or contains a pesticide chemical residue that is unsafe within the meaning of section 346a(a) of this title; or (C) if it is or if it bears or contains (i) any food additive that is unsafe within the meaning of section 348 of this title; or (ii) a new animal drug (or conversion product thereof) that is unsafe within the meaning of section 360b of this title; or (3) if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food; or (4) if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health; or (5) if it is, in whole or in part, the product of a diseased animal or of an animal which has died otherwise than by slaughter; or (6) if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or (7) if it has been intentionally subjected to radiation, unless the use of the radiation was in conformity with a regulation or exemption in effect pursuant to section 348 of this title.

(b) Absence, substitution, or addition of constituents

(1) If any valuable constituent has been in whole or in part omitted or abstracted therefrom; or (2) if any substance has been substituted wholly or in part therefor; or (3) if damage or inferiority has been concealed in any manner; or (4) if any substance has been added thereto or mixed or packed therewith so as to increase its bulk or weight, or reduce its quality or strength, or make it appear better or of greater value than it is.

(c) Color additives

If it is, or it bears or contains, a color additive which is unsafe within the meaning of section 379e(a) of this title.

(d) Confectionery containing alcohol or nonnutritive substance

If it is confectionery, and—

(1) has partially or completely imbedded therein any nonnutritive object, except that this subparagraph shall not apply in the case of any nonnutritive object if, in the judgment of the Secretary as provided by regulations, such object is of practical functional value to the confectionery product and would not render the product injurious or hazardous to health;

(2) bears or contains any alcohol other than alcohol not in excess of one-half of 1 per centum by volume derived solely from the use of flavoring extracts, except that this clause shall not apply to confectionery which is introduced or delivered for introduction into, or received or held for sale in, interstate commerce if the sale of such confectionery is permitted under the laws of the State in which such confectionery is intended to be offered for sale; or

(3) bears or contains any nonnutritive substance, except that this subparagraph shall not apply to a safe nonnutritive substance which is in or on confectionery by reason of its use for some practical functional purpose in the manufacture, packaging, or storage of such confectionery if the use of the substance does not promote deception of the consumer or otherwise result in adulteration or misbranding in violation of any provision of this chapter, except that the Secretary may, for the purpose of avoiding or resolving uncertainty as to the application of this subparagraph, issue regulations allowing or prohibiting the use of particular nonnutritive substances.

(e) Oleomargarine containing filthy, putrid, etc., matter

If it is oleomargarine or margarine or butter and any of the raw material used therein consisted in whole or in part of any filthy, putrid, or decomposed substance, or such oleomargarine or margarine or butter is otherwise unfit for food.

(f) Dietary supplement or ingredient: safety

(1) If it is a dietary supplement or contains a dietary ingredient that—

(A) presents a significant or unreasonable risk of illness or injury under—

(i) conditions of use recommended or suggested in labeling, or

(ii) if no conditions of use are suggested or recommended in the labeling, under ordinary conditions of use;

(B) is a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury;

(C) the Secretary declares to pose an imminent hazard to public health or safety, except that the authority to make such declaration shall not be delegated and the Secretary shall promptly after such a declaration initiate a proceeding in accordance with sections 554 and 556 of title 5 to affirm or withdraw the declaration; or

(D) is or contains a dietary ingredient that renders it adulterated under paragraph (a)(1) under the conditions of use recommended or suggested in the labeling of such dietary supplement.

In any proceeding under this subparagraph, the United States shall bear the burden of proof on each element to show that a dietary supplement is adulterated. The court shall decide any issue under this paragraph on a de novo basis.

(2) Before the Secretary may report to a United States attorney a violation of paragraph 2 (1)(A) for a civil proceeding, the person against whom such proceeding would be initiated shall be given appropriate notice and the opportunity to present views, orally and in writing, at least 10 days before such notice, with regard to such proceeding.

(g) Dietary supplement: manufacturing practices

(1) If it is a dietary supplement and it has been prepared, packed, or held under conditions that do not meet current good manufacturing practice regulations, including regulations requiring, when necessary, expiration date labeling, issued by the Secretary under subparagraph (2).

(2) The Secretary may by regulation prescribe good manufacturing practices for dietary supplements. Such regulations shall be modeled after current good manufacturing practice regulations for food and may not impose standards for which there is no current and generally available analytical methodology. No standard of current good manufacturing practice may be imposed unless such standard is included in a regulation promulgated after notice and opportunity for comment in accordance with chapter 5 of title 5.

(h) Reoffer of food previously denied admission

If it is an article of food imported or offered for import into the United States and the article of food has previously been refused admission under section 381(a) of this title, unless the person reoffering the article affirmatively establishes, at the expense of the owner or consignee of the article, that the article complies with the applicable requirements of this chapter, as determined by the Secretary.

(i) Noncompliance with sanitary transportation practices

If it is transported or offered for transport by a shipper, carrier by motor vehicle or rail vehicle, receiver, or any other person engaged in the transportation of food under conditions that are not in compliance with regulations promulgated under section 350e of this title.

(June 25, 1938, ch. 675, §402, 52 Stat. 1046; Mar. 16, 1950, ch. 61, §3(d), 64 Stat. 21; July 22, 1954, ch. 559, §2, 68 Stat. 511; July 9, 1956, ch. 530, 70 Stat. 512; Pub. L. 85–929, §3(a), (b), Sept. 6, 1958, 72 Stat. 1784; Pub. L. 86–2, Mar. 17, 1959, 73 Stat. 3; Pub. L. 86–618, title I, §§102(a)(1), (2), 105(c), July 12, 1960, 74 Stat. 397, 398, 404; Pub. L. 89–477, June 29, 1966, 80 Stat. 231; Pub. L. 90–399, §104, July 13, 1968, 82 Stat. 352; Pub. L. 99–252, §10, Feb. 27, 1986, 100 Stat. 35; Pub. L. 102–571, title I, §107(4), Oct. 29, 1992, 106 Stat. 4499; Pub. L. 103–80, §3(i), Aug. 13, 1993, 107 Stat. 776; Pub. L. 103–417, §§4, 9, Oct. 25, 1994, 108 Stat. 4328, 4332; Pub. L. 104–170, title IV, §404, Aug. 3, 1996, 110 Stat. 1514; Pub. L. 107–188, title III, §309, June 12, 2002, 116 Stat. 673; Pub. L. 109–59, title VII, §7202(a), Aug. 10, 2005, 119 Stat. 1911.)

Editorial Notes

Amendments

2005—Par. (i). Pub. L. 109–59 added par. (i).

2002—Par. (h). Pub. L. 107–188 added par. (h).

1996—Par. (a). Pub. L. 104–170 added subpar. (2) and struck out former subpar. (2) which read as follows: "(2)(A) if it bears or contains any added poisonous or added deleterious substance (other than one which is (i) a pesticide chemical in or on a raw agricultural commodity; (ii) a food additive; (iii) a color additive; or (iv) a new animal drug) which is unsafe within the meaning of section 346 of this title, or (B) if it is a raw agricultural commodity and it bears or contains a pesticide chemical which is unsafe within the meaning of section 346a(a) of this title, or (C) if it is, or if it bears or contains, any food additive which is unsafe within the meaning of section 348 of this title: Provided, That where a pesticide chemical has been used in or on a raw agricultural commodity in conformity with an exemption granted or a tolerance prescribed under section 346a of this title and such raw agricultural commodity has been subjected to processing such as canning, cooking, freezing, dehydrating, or milling, the residue of such pesticide chemical remaining in or on such processed food shall, notwithstanding the provisions of sections 346 and 348 of this title, not be deemed unsafe if such residue in or on the raw agricultural commodity has been removed to the extent possible in good manufacturing practice and the concentration of such residue in the processed food when ready to eat is not greater than the tolerance prescribed for the raw agricultural commodity, or (D) if it is, or it bears or contains, a new animal drug (or conversion product thereof) which is unsafe within the meaning of section 360b of this title;". That part of Pub. L. 104–170 which directed the substitution of "or (3) if it consists" for "(3) if it consists" was executed by making the substitution for "(3) If it consists" to reflect the probable intent of Congress.

1994—Par. (f). Pub. L. 103–417, §4, added par. (f).

Par. (g). Pub. L. 103–417, §9, added par. (g).

1993—Par. (a). Pub. L. 103–80, §3(i)(1), substituted a period for "; or" at end of subpar. (1) and "If it" for "if it" at beginning of par. (3). That part of Pub. L. 103–80, §3(i)(1), which directed the substitution of a period for "; or" at end of subpar. (2) could not be executed because "; or" did not appear.

Par. (d)(1). Pub. L. 103–80, §3(i)(2), substituted ", except that this subparagraph" for ": Provided, That this clause".

Par. (d)(3). Pub. L. 103–80, §3(i)(3), substituted ", except that this subparagraph shall not apply" for ": Provided, That this clause shall not apply" and ", except that the Secretary may, for the purpose of avoiding or resolving uncertainty as to the application of this subparagraph" for ": And provided further, That the Secretary may, for the purpose of avoiding or resolving uncertainty as to the application of this clause".

1992—Par. (c). Pub. L. 102–571 substituted "379e(a)" for "376(a)".

1986—Par. (d)(2). Pub. L. 99–252 inserted provision that this clause not apply to confectionery introduced or delivered for introduction into or received or held for sale in, interstate commerce if the sale is permitted under the laws of the State in which the confectionery is intended to be offered for sale.

1968—Par. (a)(2). Pub. L. 90–399 added cls. (A)(iv) and (D).

1966—Par. (d). Pub. L. 89–477 permitted the imbedding of nonnutritive objects in confectionery foods if in the judgment of the Secretary of Health, Education, and Welfare, as provided by regulation, the imbedding of the object is of practical functional value to the confectionery product and would not render it injurious or hazardous to health, raised to one-half of 1 per centum by volume the upper limit for the allowable use of alcohol derived solely from the use of flavoring extracts, allowed the use of safe nonnutritive substances in and on confectionery foods by reason of their use for some practical and functional purpose in the manufacture, packaging, or storage of the confectionery foods if the use of the substances does not promote deception of the consumer or otherwise result in adulteration or misbranding, authorized the Secretary to issue regulations on the use of particular nonnutritive substances, and removed reference to nonnutritive masticatory substances added to chewing gum and harmless flavoring, harmless resinous glaze not in excess of four-tenths of 1 per centum, natural gum, authorized coloring, and pectin.

1960—Par. (a). Pub. L. 86–618, §102(a)(1), substituted "other than one which is (i) a pesticide chemical in or on a raw agricultural commodity; (ii) a food additive; or (iii) a color additive" for "(except a pesticide chemical in or on a raw agricultural commodity and except a food additive)" in cl. (2)(A).

Par. (c). Pub. L. 86–618, §102(a)(2), amended par. (c) generally, substituting provisions deeming a food adulterated if it is, or it bears or contains, a color additive which is unsafe within the meaning of section 376 of this title for provisions which related to food that bears or contains a coal-tar color other than one from a batch that has been certified in accordance with regulations as provided by section 346 of this title, and struck out provisos which related to the use of color on oranges.

Par. (d). Pub. L. 86–618, §105(c), substituted "authorized coloring" for "harmless coloring".

1959—Par. (c). Pub. L. 86–2 extended from Mar. 1, 1959, to May 1, 1959, the period during which par. is inapplicable to oranges which have been colored with F.D. & C. Red 32, and inserted proviso requiring Secretary to establish regulations prescribing the conditions under which Citrus Red No. 2 may be safely used in coloring certain mature oranges, and providing for separately listing and for certification of batches of such color.

1958—Par. (a). Pub. L. 85–929, among other changes, inserted cl. (2)(C) relating to food additive unsafe within the meaning of section 348 of this title, and to pesticide chemical, and added cl. (7) relating to radiated food.

1956—Par. (c). Act July 9, 1956, inserted second proviso relating to coloring of oranges.

1954—Par. (a)(2). Act July 22, 1954, provided in the case of any raw agricultural commodity bearing or containing a pesticide chemical, that such commodity shall be deemed to be adulterated if such pesticide chemical is unsafe within the meaning of section 346a of this title.

1950—Par. (e). Act Mar. 16, 1950, added par. (e).

Statutory Notes and Related Subsidiaries

Effective Date of 2005 Amendment

Amendment by Pub. L. 109–59 effective Oct. 1, 2005, see section 7204 of Pub. L. 109–59, set out as a note under section 331 of this title.

Effective Date of 1968 Amendment

Amendment by Pub. L. 90–399 effective on first day of thirteenth calendar month after July 13, 1968, see section 108(a) of Pub. L. 90–399, set out as an Effective Date and Transitional Provisions note under section 360b of this title.

Effective Date of 1960 Amendment

Amendment by Pub. L. 86–618 effective July 12, 1960, subject to the provisions of section 203 of Pub. L. 86–618, see section 202 of Pub. L. 86–618, set out as a note under section 379e of this title.

Effective Date of Nematocide, Plant Regulator, Defoliant, and Desiccant Amendment of 1959

Effective date of par. (a)(2) as in force prior to July 22, 1954, with respect to particular commercial use of a nematocide, plant regulator, defoliant, or desiccant in or on a raw agricultural commodity made before Jan. 1, 1958, see section 3(b) of Pub. L. 86–139, Aug. 7, 1959, 73 Stat. 288.

Effective Date of 1958 Amendment

Pub. L. 85–929, §6, Sept. 6, 1958, 72 Stat. 1788, as amended by Pub. L. 87–19, §2, Apr. 7, 1961, 75 Stat. 42; Pub. L. 88–625, §2, Oct. 3, 1964, 78 Stat. 1002, provided that:

"(a) Except as provided in subsections (b) and (c) of this section, this Act [amending this section, sections 321, 331, 346, and 348 of this title, and section 210 of Title 42, The Public Health and Welfare, and enacting provisions set out as notes under sections 321 and 451 of this title] shall take effect on the date of its enactment [Sept. 6, 1958].

"(b) Except as provided in subsection (c) of this section, section 3 of this Act [amending this section and section 346 of this title] shall take effect on the one hundred and eightieth day after the date of enactment of this Act [Sept. 6, 1958].

"(c) With respect to any particular commercial use of a food additive, if such use was made of such additive before January 1, 1958, section 3 of this Act [amending this section and section 346 of this title] shall take effect—

"(1) Either (A) one year after the effective date established in subsection (b) of this section, or (B) at the end of such additional period (but not later than two years from such effective date established in subsection (b)) as the Secretary of Health, Education, and Welfare [now Health and Human Services] may prescribe on the basis of a finding that such extension involves no undue risk to the public health and that conditions exist which necessitate the prescribing of such an additional period, or

"(2) on the date on which an order with respect to such use under section 409 of the Federal Food, Drug, and Cosmetic Act [section 348 of this title] becomes effective,

whichever date first occurs. Whenever the Secretary has, pursuant to clause (1)(B) of this subsection, extended the effective date of section 3 of this Act [amending this section] to March 5, 1961, or has on that date a request for such extension pending before him, with respect to any such particular use of a food additive, he may, notwithstanding the parenthetical time limitation in that clause, further extend such effective date, not beyond June 30, 1964, under the authority of that clause (but subject to clause (2)) with respect to such use of the additive (or a more limited specified use or uses thereof) if, in addition to making the findings required by clause (1)(B), he finds (i) that bona fide action to determine the applicability of such section 409 [section 348 of this title] to such use or uses, or to develop the scientific data necessary for action under such section, was commenced by an interested person before March 6, 1960, and was thereafter pursued with reasonable diligence, and (ii) that in the Secretary's judgment such extension is consistent with the objective of carrying to completion in good faith, as soon as reasonably practicable, the scientific investigations necessary as a basis for action under such section 409 [section 348 of this title]: Provided, That if the Secretary has, pursuant to this sentence, granted an extension to June 30, 1964, he may, upon making the findings required by clause (1)(B) of this subsection and clauses (i) and (ii) of this sentence, further extend such effective date, but not beyond December 31, 1965. The Secretary may at any time terminate an extension so granted if he finds that it should not have been granted, or that by reason of a change in circumstances the basis for such extension no longer exists, or that there has been a failure to comply with a requirement for submission of progress reports or with other conditions attached to such extension."

Effective Date of 1954 Amendment

Act July 22, 1954, ch. 559, §5, 68 Stat. 517, provided that: "This Act [amending this section and section 321 of this title and enacting sections 346a and 346b of this title] shall take effect upon the date of its enactment [July 22, 1954], except that with respect to pesticide chemicals for which tolerances or exemptions have not been established under section 408 of the Federal Food, Drug, and Cosmetic Act [section 346a of this title], the amendment to section 402(a) of such Act [par. (a) of this section] made by section 2 of this Act shall not be effective—

"(1) for the period of one year following the date of the enactment of this Act [July 22, 1954]; or

"(2) for such additional period following such period of one year, but not extending beyond two years after the date of the enactment of this Act [July 22, 1954] as the Secretary of Health, Education, and Welfare [now Health and Human Services] may prescribe on the basis of a finding that conditions exist which necessitate the prescribing of such additional period."

Effective Date of 1950 Amendment

Amendment by act Mar. 16, 1950, effective July 1, 1950, see section 7 of act Mar. 16, 1950, set out as an Effective Date note under section 347 of this title.

Effective Date; Postponement

Par. (c) effective Jan. 1, 1940, see act June 23, 1939, ch. 242, 53 Stat. 853, set out as an Effective Date; Postponement in Certain Cases note under section 301 of this title.

Short Title

Pub. L. 88–625, §1, Oct. 3, 1964, 78 Stat. 1002, provided: "That this Act [amending provisions set out as a note under this section and section 135 of Title 7, Agriculture] may be cited as the 'Food Additives Transitional Provisions Amendment of 1964'."

Updating Guidance Relating to Fish and Fisheries Products Hazards and Controls

Pub. L. 111–353, title I, §103(h), Jan. 4, 2011, 124 Stat. 3898, provided that: "The Secretary shall, not later than 180 days after the date of enactment of this Act [Jan. 4, 2011], update the Fish and Fisheries Products Hazards and Control Guidance to take into account advances in technology that have occurred since the previous publication of such Guidance by the Secretary."

Guidance Relating to Post Harvest Processing of Raw Oysters

Pub. L. 111–353, title I, §114, Jan. 4, 2011, 124 Stat. 3921, provided that:

"(a) In General.—Not later than 90 days prior to the issuance of any guidance, regulation, or suggested amendment by the Food and Drug Administration to the National Shellfish Sanitation Program's Model Ordinance, or the issuance of any guidance or regulation by the Food and Drug Administration relating to the Seafood Hazard Analysis Critical Control Points Program of the Food and Drug Administration (parts 123 and 1240 of title 21, Code of Federal Regulations (or any successor regulations)[)], where such guidance, regulation or suggested amendment relates to post harvest processing for raw oysters, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report which shall include—

"(1) an assessment of how post harvest processing or other equivalent controls feasibly may be implemented in the fastest, safest, and most economical manner;

"(2) the projected public health benefits of any proposed post harvest processing;

"(3) the projected costs of compliance with such post harvest processing measures;

"(4) the impact post harvest processing is expected to have on the sales, cost, and availability of raw oysters;

"(5) criteria for ensuring post harvest processing standards will be applied equally to shellfish imported from all nations of origin;

"(6) an evaluation of alternative measures to prevent, eliminate, or reduce to an acceptable level the occurrence of foodborne illness; and

"(7) the extent to which the Food and Drug Administration has consulted with the States and other regulatory agencies, as appropriate, with regard to post harvest processing measures.

"(b) Limitation.—Subsection (a) shall not apply to the guidance described in section 103(h) [section 103(h) of Pub. L. 111–353, set out as a note above].

"(c) Review and Evaluation.—Not later than 30 days after the Secretary issues a proposed regulation or guidance described in subsection (a), the Comptroller General of the United States shall—

"(1) review and evaluate the report described in (a) and report to Congress on the findings of the estimates and analysis in the report;

"(2) compare such proposed regulation or guidance to similar regulations or guidance with respect to other regulated foods, including a comparison of risks the Secretary may find associated with seafood and the instances of those risks in such other regulated foods; and

"(3) evaluate the impact of post harvest processing on the competitiveness of the domestic oyster industry in the United States and in international markets.

"(d) Waiver.—The requirement of preparing a report under subsection (a) shall be waived if the Secretary issues a guidance that is adopted as a consensus agreement between Federal and State regulators and the oyster industry, acting through the Interstate Shellfish Sanitation Conference.

"(e) Public Access.—Any report prepared under this section shall be made available to the public."

Domestic Fish or Fish Product Compliance With Food Safety Standards or Procedures Deemed To Have Met Requirements for Federal Commodity Purchase Programs

Pub. L. 104–180, title VII, §733, Aug. 6, 1996, 110 Stat. 1601, provided that: "Hereafter, notwithstanding any other provision of law, any domestic fish or fish product produced in compliance with food safety standards or procedures accepted by the Food and Drug Administration as satisfying the requirements of the 'Procedures for the Safe and Sanitary Processing and Importing of Fish and Fish Products' (published by the Food and Drug Administration as a final regulation in the Federal Register of December 18, 1995), shall be deemed to have met any inspection requirements of the Department of Agriculture or other Federal agency for any Federal commodity purchase program, including the program authorized under section 32 of the Act of August 24, 1935 (7 U.S.C. 612c) except that the Department of Agriculture or other Federal agency may utilize lot inspection to establish a reasonable degree of certainty that fish or fish products purchased under a Federal commodity purchase program, including the program authorized under section 32 of the Act of August 24, 1935 (7 U.S.C. 612c), meet Federal product specifications."

Executive Documents

Transfer of Functions

For transfer of functions of Federal Security Administrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration in the Department of Agriculture to Federal Security Agency, see notes set out under section 321 of this title.

1 So in original. The period probably should be "; or".

2 So in original. Probably should be "subparagraph".
21 U.S.C. § 1174 (2024) — Title 21: FOOD AND DRUGS / Chapter 16: DRUG ABUSE PREVENTION, TREATMENT, AND REHABILITATION / Subchapter IV: OTHER FEDERAL PROGRAMS / Section 1174: Transferred
Transferred
Status: transferred

Editorial Notes

Codification

Section 1174, Pub. L. 92–255, title IV, §407, Mar. 21, 1972, 86 Stat. 78; Pub. L. 94–237, §6(a), Mar. 19, 1976, 90 Stat. 244; Pub. L. 94–581, title I, §111(c)(2), Oct. 21, 1976, 90 Stat. 2852, which prohibited discrimination against drug abusers by general hospitals, was redesignated section 526 of the Public Health Service Act by Pub. L. 98–24, §2(b)(16)(B), Apr. 26, 1983, 97 Stat. 182, and is classified to section 290ee–2 of Title 42, The Public Health and Welfare.

Section 1175, Pub. L. 92–255, title IV, §408, Mar. 21, 1972, 86 Stat. 79; Pub. L. 93–282, title III, §303(a), (b), May 14, 1974, 88 Stat. 137, 138; Pub. L. 94–237, §4(c)(5)(A), (B), Mar. 19, 1976, 90 Stat. 244; Pub. L. 94–581, title I, §111(c)(3), Oct. 21, 1976, 90 Stat. 2852; Pub. L. 97–35, title IX, §973(d), Aug. 13, 1981, 95 Stat. 598, which related to confidentiality of patients' records, was redesignated section 527 of the Public Health Service Act by Pub. L. 98–24, §2(b)(16)(B), Apr. 26, 1983, 97 Stat. 182, and is classified to section 290ee–3 of Title 42.
21 U.S.C. § 379e (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter VII: GENERAL AUTHORITY / Section 379e: Listing and certification of color additives for foods, drugs, devices, and cosmetics
Listing and certification of color additives for foods, drugs, devices, and cosmetics
Status: in_force

(a) Unsafe color additives

A color additive shall, with respect to any particular use (for which it is being used or intended to be used or is represented as suitable) in or on food or drugs or devices or cosmetics, be deemed unsafe for the purposes of the application of section 342(c), 351(a)(4), or 361(e) of this title, as the case may be, unless—

(1)(A) there is in effect, and such additive and such use are in conformity with, a regulation issued under subsection (b) of this section listing such additive for such use, including any provision of such regulation prescribing the conditions under which such additive may be safely used, and (B) such additive either (i) is from a batch certified, in accordance with regulations issued pursuant to subsection (c), for such use, or (ii) has, with respect to such use, been exempted by the Secretary from the requirement of certification; or

(2) such additive and such use thereof conform to the terms of an exemption which is in effect pursuant to subsection (f) of this section.

While there are in effect regulations under subsections (b) and (c) of this section relating to a color additive or an exemption pursuant to subsection (f) with respect to such additive, an article shall not, by reason of bearing or containing such additive in all respects in accordance with such regulations or such exemption, be considered adulterated within the meaning of clause (1) of section 342(a) of this title if such article is a food, or within the meaning of section 361(a) of this title if such article is a cosmetic other than a hair dye (as defined in the last sentence of section 361(a) of this title). A color additive for use in or on a device shall be subject to this section only if the color additive comes in direct contact with the body of man or other animals for a significant period of time. The Secretary may by regulation designate the uses of color additives in or on devices which are subject to this section.

(b) Listing of colors; regulations; issuance, amendment or repeal; referral to advisory committee; report and recommendations; appointment and compensation of advisory committee

(1) The Secretary shall, by regulation, provide for separately listing color additives for use in or on food, color additives for use in or on drugs, or devices, and color additives for use in or on cosmetics, if and to the extent that such additives are suitable and safe for any such use when employed in accordance with such regulations.

(2)(A) Such regulations may list any color additive for use generally in or on food, or in or on drugs or devices, or in or on cosmetics, if the Secretary finds that such additive is suitable and may safely be employed for such general use.

(B) If the data before the Secretary do not establish that the additive satisfies the requirements for listing such additive on the applicable list pursuant to subparagraph (A) of this paragraph, or if the proposal is for listing such additive for a more limited use or uses, such regulations may list such additive only for any more limited use or uses for which it is suitable and may safely be employed.

(3) Such regulations shall, to the extent deemed necessary by the Secretary to assure the safety of the use or uses for which a particular color additive is listed, prescribe the conditions under which such additive may be safely employed for such use or uses (including, but not limited to, specifications, hereafter in this section referred to as tolerance limitations, as to the maximum quantity or quantities which may be used or permitted to remain in or on the article or articles in or on which it is used; specifications as to the manner in which such additive may be added to or used in or on such article or articles; and directions or other labeling or packaging requirements for such additive).

(4) The Secretary shall not list a color additive under this section for a proposed use unless the data before him establish that such use, under the conditions of use specified in the regulations, will be safe: Provided, however, That a color additive shall be deemed to be suitable and safe for the purpose of listing under this subsection for use generally in or on food, while there is in effect a published finding of the Secretary declaring such substance exempt from the term "food additive" because of its being generally recognized by qualified experts as safe for its intended use, as provided in section 321(s) of this title.

(5)(A) In determining, for the purposes of this section, whether a proposed use of a color additive is safe, the Secretary shall consider, among other relevant factors—

(i) the probable consumption of, or other relevant exposure from, the additive and of any substance formed in or on food, drugs or devices, or cosmetics because of the use of the additive;

(ii) the cumulative effect, if any, of such additive in the diet of man or animals, taking into account the same or any chemically or pharmacologically related substance or substances in such diet;

(iii) safety factors which, in the opinion of experts qualified by scientific training and experience to evaluate the safety of color additives for the use or uses for which the additive is proposed to be listed, are generally recognized as appropriate for the use of animal experimentation data; and

(iv) the availability of any needed practicable methods of analysis for determining the identity and quantity of (I) the pure dye and all intermediates and other impurities contained in such color additive, (II) such additive in or on any article of food, drug or device, or cosmetic, and (III) any substance formed in or on such article because of the use of such additive.

(B) A color additive (i) shall be deemed unsafe, and shall not be listed, for any use which will or may result in ingestion of all or part of such additive, if the additive is found by the Secretary to induce cancer when ingested by man or animal, or if it is found by the Secretary, after tests which are appropriate for the evaluation of the safety of additives for use in food, to induce cancer in man or animal, and (ii) shall be deemed unsafe, and shall not be listed, for any use which will not result in ingestion of any part of such additive, if, after tests which are appropriate for the evaluation of the safety of additives for such use, or after other relevant exposure of man or animal to such additive, it is found by the Secretary to induce cancer in man or animal: Provided, That clause (i) of this subparagraph (B) shall not apply with respect to the use of a color additive as an ingredient of feed for animals which are raised for food production, if the Secretary finds that, under the conditions of use and feeding specified in proposed labeling and reasonably certain to be followed in practice, such additive will not adversely affect the animals for which such feed is intended, and that no residue of the additive will be found (by methods of examination prescribed or approved by the Secretary by regulations, which regulations shall not be subject to subsection (d)) in any edible portion of such animals after slaughter or in any food yielded by or derived from the living animal.

(C)(i) In any proceeding for the issuance, amendment, or repeal of a regulation listing a color additive, whether commenced by a proposal of the Secretary on his own initiative or by a proposal contained in a petition, the petitioner, or any other person who will be adversely affected by such proposal or by the Secretary's order issued in accordance with paragraph (1) of section 371(e) of this title if placed in effect, may request, within the time specified in this subparagraph, that the petition or order thereon, or the Secretary's proposal, be referred to an advisory committee for a report and recommendations with respect to any matter arising under subparagraph (B) of this paragraph, which is involved in such proposal or order and which requires the exercise of scientific judgment. Upon such request, or if the Secretary within such time deems such a referral necessary, the Secretary shall forthwith appoint an advisory committee under subparagraph (D) of this paragraph and shall refer to it, together with all the data before him, such matter arising under subparagraph (B) for study thereof and for a report and recommendations on such matter. A person who has filed a petition or who has requested the referral of a matter to an advisory committee pursuant to this subparagraph (C), as well as representatives of the Department, shall have the right to consult with such advisory committee in connection with the matter referred to it. The request for referral under this subparagraph, or the Secretary's referral on his own initiative, may be made at any time before, or within thirty days after, publication of an order of the Secretary acting upon the petition or proposal.

(ii) Within sixty days after the date of such referral, or within an additional thirty days if the committee deems such additional time necessary, the committee shall, after independent study of the data furnished to it by the Secretary and other data before it, certify to the Secretary a report and recommendations, together with all underlying data and a statement of the reasons or basis for the recommendations. A copy of the foregoing shall be promptly supplied by the Secretary to any person who has filed a petition, or who has requested such referral to the advisory committee. Within thirty days after such certification, and after giving due consideration to all data then before him, including such report, recommendations, underlying data, and statement, and to any prior order issued by him in connection with such matter, the Secretary shall by order confirm or modify any order theretofore issued or, if no such prior order has been issued, shall by order act upon the petition or other proposal.

(iii) Where—

(I) by reason of subparagraph (B) of this paragraph, the Secretary has initiated a proposal to remove from listing a color additive previously listed pursuant to this section; and

(II) a request has been made for referral of such proposal to an advisory committee;

the Secretary may not act by order on such proposal until the advisory committee has made a report and recommendations to him under clause (ii) of this subparagraph and he has considered such recommendations, unless the Secretary finds that emergency conditions exist necessitating the issuance of an order notwithstanding this clause.

(D) The advisory committee referred to in subparagraph (C) of this paragraph shall be composed of experts selected by the National Academy of Sciences, qualified in the subject matter referred to the committee and of adequately diversified professional background, except that in the event of the inability or refusal of the National Academy of Sciences to act, the Secretary shall select the members of the committee. The size of the committee shall be determined by the Secretary. Members of any advisory committee established under this chapter, while attending conferences or meetings of their committees or otherwise serving at the request of the Secretary, shall be entitled to receive compensation at rates to be fixed by the Secretary but at rates not exceeding the daily equivalent of the rate specified at the time of such service for grade GS–18 of the General Schedule, including traveltime; and while away from their homes or regular places of business they may be allowed travel expenses, including per diem in lieu of subsistence, as authorized by section 5703 of title 5 for persons in the Government service employed intermittently. The members shall not be subject to any other provisions of law regarding the appointment and compensation of employees of the United States. The Secretary shall furnish the committee with adequate clerical and other assistance, and shall by rules and regulations prescribe the procedure to be followed by the committee.

(6) The Secretary shall not list a color additive under this subsection for a proposed use if the data before him show that such proposed use would promote deception of the consumer in violation of this chapter or would otherwise result in misbranding or adulteration within the meaning of this chapter.

(7) If, in the judgment of the Secretary, a tolerance limitation is required in order to assure that a proposed use of a color additive will be safe, the Secretary—

(A) shall not list the additive for such use if he finds that the data before him do not establish that such additive, if used within a safe tolerance limitation, would achieve the intended physical or other technical effect; and

(B) shall not fix such tolerance limitation at a level higher than he finds to be reasonably required to accomplish the intended physical or other technical effect.

(8) If, having regard to the aggregate quantity of color additive likely to be consumed in the diet or to be applied to the human body, the Secretary finds that the data before him fail to show that it would be safe and otherwise permissible to list a color additive (or pharmacologically related color additives) for all the uses proposed therefor and at the levels of concentration proposed, the Secretary shall, in determining for which use or uses such additive (or such related additives) shall be or remain listed, or how the aggregate allowable safe tolerance for such additive or additives shall be allocated by him among the uses under consideration, take into account, among other relevant factors (and subject to the paramount criterion of safety), (A) the relative marketability of the articles involved as affected by the proposed uses of the color additive (or of such related additives) in or on such articles, and the relative dependence of the industries concerned on such uses; (B) the relative aggregate amounts of such color additive which he estimates would be consumed in the diet or applied to the human body by reason of the various uses and levels of concentration proposed; and (C) the availability, if any, of other color additives suitable and safe for one or more of the uses proposed.

(c) Certification of colors

The Secretary shall further, by regulation, provide (1) for the certification, with safe diluents or without diluents, of batches of color additives listed pursuant to subsection (b) and conforming to the requirements for such additives established by regulations under such subsection and this subsection, and (2) for exemption from the requirement of certification in the case of any such additive, or any listing or use thereof, for which he finds such requirement not to be necessary in the interest of the protection of the public health: Provided, That, with respect to any use in or on food for which a listed color additive is deemed to be safe by reason of the proviso to paragraph (4) of subsection (b), the requirement of certification shall be deemed not to be necessary in the interest of public health protection.

(d) Procedure for issuance, amendment, or repeal of regulations

The provisions of section 371(e), (f), and (g) of this title shall, subject to the provisions of subparagraph (C) of subsection (b)(5) of this section, apply to and in all respects govern proceedings for the issuance, amendment, or repeal of regulations under subsection (b) or (c) of this section (including judicial review of the Secretary's action in such proceedings) and the admissibility of transcripts of the record of such proceedings in other proceedings, except that—

(1) if the proceeding is commenced by the filing of a petition, notice of the proposal made by the petition shall be published in general terms by the Secretary within thirty days after such filing, and the Secretary's order (required by paragraph (1) of section 371(e) of this title) acting upon such proposal shall, in the absence of prior referral (or request for referral) to an advisory committee, be issued within ninety days after the date of such filing, except that the Secretary may (prior to such ninetieth day), by written notice to the petitioner, extend such ninety-day period to such time (not more than one hundred and eighty days after the date of filing of the petition) as the Secretary deems necessary to enable him to study and investigate the petition;

(2) any report, recommendations, underlying data, and reasons certified to the Secretary by an advisory committee appointed pursuant to subparagraph (D) of subsection (b)(5) of this section, shall be made a part of the record of any hearing if relevant and material, subject to the provisions of section 556(d) of title 5. The advisory committee shall designate a member to appear and testify at any such hearing with respect to the report and recommendations of such committee upon request of the Secretary, the petitioner, or the officer conducting the hearing, but this shall not preclude any other member of the advisory committee from appearing and testifying at such hearing;

(3) the Secretary's order after public hearing (acting upon objections filed to an order made prior to hearing) shall be subject to the requirements of section 348(f)(2) of this title; and

(4) the scope of judicial review of such order shall be in accordance with the fourth sentence of paragraph (2), and with the provisions of paragraph (3), of section 348(g) of this title.

(e) Fees

The admitting to listing and certification of color additives, in accordance with regulations prescribed under this chapter, shall be performed only upon payment of such fees, which shall be specified in such regulations, as may be necessary to provide, maintain, and equip an adequate service for such purposes.

(f) Exemptions

The Secretary shall by regulations (issued without regard to subsection (d)) provide for exempting from the requirements of this section any color additive or any specific type of use thereof, and any article of food, drug, or device, or cosmetic bearing or containing such additive, intended solely for investigational use by qualified experts when in his opinion such exemption is consistent with the public health.

(June 25, 1938, ch. 675, §721, formerly §706, 52 Stat. 1058; Pub. L. 86–618, title I, §103(b), July 12, 1960, 74 Stat. 399; Pub. L. 87–781, title I, §104(f)(2), Oct. 10, 1962, 76 Stat. 785; Pub. L. 91–515, title VI, §601(d)(2), Oct. 30, 1970, 84 Stat. 1311; Pub. L. 94–295, §9(a), May 28, 1976, 90 Stat. 583; Pub. L. 96–88, title V, §509(b), Oct. 17, 1979, 93 Stat. 695; Pub. L. 102–300, §6(b)(2), June 16, 1992, 106 Stat. 240; renumbered §721, Pub. L. 102–571, title I, §106(4), Oct. 29, 1992, 106 Stat. 4498; Pub. L. 103–80, §3(bb), Aug. 13, 1993, 107 Stat. 778.)

Editorial Notes

Codification

Section was formerly classified to section 376 of this title prior to renumbering by Pub. L. 102–571.

In subsec. (d)(2), "section 556(d) of title 5" substituted for "section 7(c) of the Administrative Procedure Act (5 U.S.C., sec. 1006(c))" on authority of Pub. L. 89–554, §7(b), Sept. 6, 1966, 80 Stat. 631, the first section of which enacted Title 5, Government Organization and Employees.

Amendments

1993—Subsec. (b)(5)(D). Pub. L. 103–80 substituted "section 5703" for "section 5703(b)".

1992—Subsec. (b)(5)(C)(i). Pub. L. 102–300 struck out "of Health, Education, and Welfare" after "representatives of the Department".

1976—Subsec. (a). Pub. L. 94–295, §9(a)(2), (3), inserted reference to devices and inserted provisions directing that color additives for use in or on devices be subject to this section only if the color additives come in direct contact with the body of man or other animals for a significant period of time and authorizing the Secretary to designate by regulation the uses of color additives in or on devices which are subject to this section.

Subsec. (b). Pub. L. 94–295, §9(a)(1), (2), substituted "drug or device" for "drug" and "drugs or devices" for "drugs" wherever appearing.

Subsec. (f). Pub. L. 94–295, §9(a)(1), substituted "drug or device" for "drug".

1970—Subsec. (b)(5)(D). Pub. L. 91–515 substituted provisions authorizing members of an advisory committee to receive compensation at rates fixed by the Secretary, with a specific maximum amount, and travel expenses, including per diem in lieu of subsistence, as authorized by section 5703(b) of Title 5, for provisions authorizing such members to receive as compensation a reasonable per diem for time actually spent on committee work, and necessary traveling and subsistence expenses while serving away from their places of residence.

1962—Subsec. (b)(5)(B). Pub. L. 87–781 provided that clause (i) of this subparagraph shall not apply to a color additive in feed of animals raised for food production, if under the conditions of use specified in proposed labeling, and which conditions are reasonably certain to be followed in practice, such additive will not adversely affect the animals and no residue will be found in any edible portion of such animal after slaughter or in any food from the living animal.

1960—Pub. L. 86–618 amended section generally. Prior to amendment, section read as follows: "The admitting to listing and certification of coal-tar colors, in accordance with regulations prescribed under this chapter, shall be performed only upon payment of such fees, which shall be specified in such regulations, as may be necessary to provide, maintain, and equip an adequate service for such purposes."

Statutory Notes and Related Subsidiaries

Effective Date of 1962 Amendment

Amendment by Pub. L. 87–781 effective Oct. 10, 1962, see section 107 of Pub. L. 87–781, set out as a note under section 321 of this title.

Effective Date of 1960 Amendment, Transitional Provisions, and Effect on Other Laws

Pub. L. 86–618, title II, July 12, 1960, 74 Stat. 404, provided that:

"Sec. 201. [Definitions.] As used in this title, the term 'basic Act' means the Federal Food, Drug, and Cosmetic Act [this chapter]; the term 'enactment date' means the date of enactment of this Act [July 12, 1960]; and other terms, insofar as also used in the basic Act (whether before or after enactment of this Act) shall have the same meaning as they have, or had when in effect, under the basic Act.

"Sec. 202. [Effective Date.] This Act [amending this section and sections 321, 331, 333, 342, 343, 346, 351, 352, 361, 362, and 371 of this title and repealing sections 354 and 364 of this title] shall, subject to the provisions of section 203, take effect on the enactment date [July 12, 1960].

"Sec. 203. [Provisional Listings of Commercially Established Colors.] (a)(1) The purpose of this section is to make possible, on an interim basis for a reasonable period, through provisional listings, the use of commercially established color additives to the extent consistent with the public health, pending the completion of the scientific investigations needed as a basis for making determinations as to listing of such additives under the basic Act as amended by this Act. A provisional listing (including a deemed provisional listing) of a color additive under this section for any use shall, unless sooner terminated or expiring under the provisions of this section, expire (A) on the closing date (as defined in paragraph (2) of this subsection) or (B) on the effective date of a listing of such additive for such use under section 706 [now 721] of the basic Act, [this section], whichever date first occurs.

"(2) For the purposes of this section, the term 'closing date' means (A) the last day of the two and one-half year period beginning on the enactment date [July 12, 1960] or (B), with respect to a particular provisional listing (or deemed provisional listing) of a color additive or use thereof, such later closing date as the Secretary may from time to time establish pursuant to the authority of this paragraph. The Secretary may by regulation, upon application of an interested person or on his own initiative, from time to time postpone the original closing date with respect to a provisional listing (or deemed provisional listing) under this section of a specified color additive, or of a specified use or uses of such additive, for such period or periods as he finds necessary to carry out the purpose of this section, if in the Secretary's judgment such action is consistent with the objective of carrying to completion in good faith, as soon as reasonably practicable, the scientific investigations necessary for making a determination as to listing such additive, or such specified use or uses thereof, under section 706 [now 721] of the basic Act [this section]. The Secretary may terminate a postponement of the closing date at any time if he finds that such postponement should not have been granted, or that by reason of a change in circumstances the basis for such postponement no longer exists, or that there has been a failure to comply with a requirement for submission of progress reports or with other conditions attached to such postponement.

"(b) Subject to the other provisions of this section—

"(1) any color additive which, on the day preceding the enactment date [July 12, 1960], was listed and certifiable for any use or uses under section 406(b), 504, or 604 [section 346(b), 354, or 364 of this title], or under the third proviso of section 402(c) [section 342(c) of this title], of the basic Act, and of which a batch or batches had been certified for such use or uses prior to the enactment date [July 12, 1960], and

"(2) any color additive which was commercially used or sold prior to the enactment date [July 12, 1960] for any use or uses in or on any food, drug, or cosmetic, and which either, (A), on the day preceding the enactment date [July 12, 1960], was not a material within the purview of any of the provisions of the basic Act enumerated in paragraph (1) of this subsection, or (B) is the color additive known as synthetic beta-carotene,

shall, beginning on the enactment date [July 12, 1960], be deemed to be provisionally listed under this section as a color additive for such use or uses.

"(c) Upon request of any person, the Secretary, by regulations issued under subsection (d), shall without delay, if on the basis of the data before him he deems such action consistent with the protection of the public health, provisionally list a material as a color additive for any use for which it was listed, and for which a batch or batches of such material had been certified, under section 406(b), 504, or 604 of the basic Act [section 346(b), 354, or 364 of this title] prior to the enactment date [July 12, 1960], although such color was no longer listed and certifiable for such use under such sections on the day preceding the enactment date. Such provisional listing shall take effect on the date of publication.

"(d)(1) The Secretary shall, by regulations issued or amended from time to time under this section—

"(A) insofar as practicable promulgate and keep current a list or lists of the color additives, and of the particular uses thereof, which he finds are deemed provisionally listed under subsection (b), and the presence of a color additive on such a list with respect to a particular use shall, in any proceeding under the basic Act, be conclusive evidence that such provisional listing is in effect;

"(B) provide for the provisional listing of the color additives and particular uses thereof specified in subsection (c);

"(C) provide, with respect to particular uses for which color additives are or are deemed to be provisionally listed, such temporary tolerance limitations (including such limitations at zero level) and other conditions of use and labeling or packaging requirements, if any, as in his judgment are necessary to protect the public health pending listing under section 706 [now 721] of the basic Act [this section];

"(D) provide for the certification of batches of such color additives (with or without diluents) for the uses for which they are so listed or deemed to be listed under this section, except that such an additive which is a color additive deemed provisionally listed under subsection (b)(2) of this section shall be deemed exempt from the requirement of such certification while not subject to a tolerance limitation; and

"(E) provide for the termination of a provisional listing (or deemed provisional listing) of a color additive or particular use thereof forthwith whenever in his judgment such action is necessary to protect the public health.

"(2)(A) Except as provided in subparagraph (C) of this paragraph, regulations under this section shall, from time to time, be issued, amended, or repealed by the Secretary without regard to the requirements of the basic Act [subsec. (e) of this section], but for the purposes of the application of section 706(e) [now 721(e)] of the basic Act (relating to fees) and of determining the availability of appropriations of fees (and of advance deposits to cover fees), proceedings, regulations, and certifications under this section shall be deemed to be proceedings, regulations, and certifications under such section 706 [now 721, this section]. Regulations providing for fees (and advance deposits to cover fees), which on the day preceding the enactment date [July 12, 1960] were in effect pursuant to section 706 [now 721] of the basic Act [this section], shall be deemed to be regulations under such section 706 [now 721, this section] as amended by this Act, and appropriations of fees (and advance deposits) available for the purposes specified in such section 706 [now 721] as in effect prior to the enactment date [July 12, 1960] shall be available for the purposes specified in such section 706 [now 721, this section] as so amended.

"(B) If the Secretary, by regulation—

"(i) has terminated a provisional listing (or deemed provisional listing) of a color additive or particular use thereof pursuant to paragraph (1)(E) of this subsection; or

"(ii) has, pursuant to paragraph (1)(C) or paragraph (3) of this subsection, initially established or rendered more restrictive a tolerance limitation or other restriction or requirement with respect to a provisional listing (or deemed provisional listing) which listing had become effective prior to such action,

any person adversely affected by such action may, prior to the expiration of the period specified in clause (A) of subsection (a)(2) of this section, file with the Secretary a petition for amendment of such regulation so as to revoke or modify such action of the Secretary, but the filing of such petition shall not operate to stay or suspend the effectiveness of such action. Such petition shall, in accordance with regulations, set forth the proposed amendment and shall contain data (or refer to data which are before the Secretary or of which he will take official notice), which show that the revocation or modification proposed is consistent with the protection of the public health. The Secretary shall, after publishing such proposal and affording all interested persons an opportunity to present their views thereon orally or in writing, act upon such proposal by published order.

"(C) Any person adversely affected by an order entered under subparagraph (B) of this paragraph may, within thirty days after its publication, file objections thereto with the Secretary, specifying with particularity the provisions of the order deemed objectionable, stating reasonable grounds for such objections, and requesting a public hearing upon such objections. The Secretary shall hold a public hearing on such objections and shall, on the basis of the evidence adduced at such hearing, act on such objections by published order. Such order may reinstate a terminated provisional listing, or increase or dispense with a previously established temporary tolerance limitation, or make less restrictive any other limitation established by him under paragraph (1) or (3) of this subsection, only if in his judgment the evidence so adduced shows that such action will be consistent with the protection of the public health. An order entered under this subparagraph shall be subject to judicial review in accordance with section 701(f) of the basic Act [section 371(f) of this title] except that the findings and order of the Secretary shall be sustained only if based upon a fair evaluation of the entire record at such hearing. No stay or suspension of such order shall be ordered by the court pending conclusion of such judicial review.

"(D) On and after the enactment date [July 12, 1960], regulations, provisional listings, and certifications (or exemptions from certification) in effect under this section shall, for the purpose of determining whether an article is adulterated or misbranded within the meaning of the basic Act by reason of its being, bearing, or containing a color additive, have the same effect as would regulations, listings, and certifications (or exemptions from certification) under section 706 [now 721] of the basic Act [this section]. A regulation, provisional listing or termination thereof, tolerance limitation, or certification or exemption therefrom, under this section shall not be the basis for any presumption or inference in any proceeding under section 706(b) or (c) [now 721(b), (c)] of the basic Act [subsec. (b) or (c) of this section].

"(3) For the purpose of enabling the Secretary to carry out his functions under paragraphs (1)(A) and (C) of this subsection with respect to color additives deemed provisionally listed, he shall, as soon as practicable after enactment of this Act [July 12, 1960], afford by public notice a reasonable opportunity to interested persons to submit data relevant thereto. If the data so submitted or otherwise before him do not, in his judgment, establish a reliable basis for including such a color additive or particular use or uses thereof in a list or lists promulgated under paragraph (1)(A), or for determining the prevailing level or levels of use thereof prior to the enactment date [July 12, 1960] with a view to prescribing a temporary tolerance or tolerances for such use or uses under paragraph (1)(C), the Secretary shall establish a temporary tolerance limitation at zero level for such use or uses until such time as he finds that it would not be inconsistent with the protection of the public health to increase or dispense with such temporary tolerance limitation.

"Sec. 204. [Effect on Meat Inspection and Poultry Products Inspection Acts.] Nothing in this Act [amending this section and sections 321, 331, 333, 342, 343, 346, 351, 352, 361, 362, and 371 of this title and repealing sections 354 and 364 of this title] shall be construed to exempt any meat or meat food product, poultry or poultry product, or any person from any requirement imposed by or pursuant to the Meat Inspection Act of March 4, 1907, 34 Stat. 1260, as amended or extended (21 U.S.C. 71 and the following) [see section 601 et seq. of this title] or the Poultry Products Inspection Act (21 U.S.C. 451 and the following)."

Effective Date; Acceleration

This section was made "immediately effective" by act May 2, 1939, ch. 107, title I, §1, 53 Stat. 631.

Termination of Advisory Committees

Advisory committees in existence on Jan. 5, 1973, to terminate not later than the expiration of the 2-year period following Jan. 5, 1973, and advisory committees established after Jan. 5, 1973, to terminate not later than the expiration of the 2-year period beginning on the date of their establishment, unless in the case of a committee established by the President or an officer of the Federal Government, such committee is renewed by appropriate action prior to the expiration of such 2-year period, or in the case of a committee established by Congress, its duration is otherwise provided by law. See section 1013 of Title 5, Government Organization and Employees.

References in Other Laws to GS–16, 17, or 18 Pay Rates

References in laws to the rates of pay for GS–16, 17, or 18, or to maximum rates of pay under the General Schedule, to be considered references to rates payable under specified sections of Title 5, Government Organization and Employees, see section 529 [title I, §101(c)(1)] of Pub. L. 101–509, set out in a note under section 5376 of Title 5.
21 U.S.C. § 1102 (2024) — Title 21: FOOD AND DRUGS / Chapter 16: DRUG ABUSE PREVENTION, TREATMENT, AND REHABILITATION / Subchapter I: GENERAL PROVISIONS / Section 1102: Congressional declaration of national policy
Congressional declaration of national policy
Status: in_force

The Congress declares that it is the policy of the United States and the purpose of this chapter to focus the comprehensive resources of the Federal Government and bring them to bear on drug abuse with the objective of significantly reducing the incidence, as well as the social and personal costs, of drug abuse in the United States, and to develop and assure the implementation of a comprehensive, coordinated long-term Federal strategy to combat drug abuse. To reach these goals, the Congress further declares that it is the policy of the United States and the purpose of this chapter to meet the problems of drug abuse through—

(1) comprehensive Federal, State, and local planning for, and effective use of, Federal assistance to States and to community-based programs to meet the urgent needs of special populations, in coordination with all other governmental and nongovernmental sources of assistance;

(2) the development and support of community-based prevention programs;

(3) the development and encouragement of effective occupational prevention and treatment programs within the Government and in cooperation with the private sector; and

(4) increased Federal commitment to research into the behavioral and biomedical etiology of, the treatment of, and the mental and physical health and social and economic consequences of, drug abuse.

(Pub. L. 92–255, title I, §102, Mar. 21, 1972, 86 Stat. 66; Pub. L. 94–237, §2, Mar. 19, 1976, 90 Stat. 241; Pub. L. 96–181, §3, Jan. 2, 1980, 93 Stat. 1309.)

Editorial Notes

References in Text

This chapter, referred to in text, was in the original "this Act", meaning Pub. L. 92–255, Mar. 21, 1972, 86 Stat. 65, known as the Drug Abuse Prevention, Treatment, and Rehabilitation Act, which comprises this chapter. For complete classification of this Act to the Code, see Short Title note set out under section 1101 of this title and Tables.

Amendments

1980—Pub. L. 96–181 inserted additional declarations of policy prescribing methods and programs by which the goals are to be reached.

1976—Pub. L. 94–237 substituted "objective of significantly reducing the incidence, as well as the social and personal costs, of drug abuse in the United States, and to develop and assure the implementation of" for "immediate objective of significantly reducing the incidence of drug abuse in the United States within the shortest possible period of time, and to develop".