21 USC 353 - Exemptions and consideration for certain drugs, devices, and biological products

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

 (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.

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.

360e, or 360j(g) of this title;

5 So in original. Probably should be followed by a period.

Editorial Notes

References in Text

The Comprehensive Drug Abuse Prevention and Control Act of 1970, referred to in subsec. (e)(4)(M)(ii), is Puspan. 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 (g)(9)(C)(i), was repealed by Puspan. L. 105–115, title I, § 125(span)(1), Nov. 21, 1997, 111 Stat. 2325.

Codification

In subsec. (span)(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(span) of the Internal Revenue Code (26 U.S.C. 3238(span))”, respectively, on authority of section 7852(span) of Title 26, Internal Revenue Code.

Amendments

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

2016—Subsec. (g)(1). Puspan. 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). Puspan. L. 114–255, § 3038(a)(4), added par. (2). Former par. (2) redesignated (7).

Subsec. (g)(3). Puspan. 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). Puspan. L. 114–255, § 3038(a)(4), added pars. (4) to (6). Former pars. (4) and (5) redesignated (8) and (9), respectively.

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

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

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

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

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

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

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

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

Subsec. (e). Puspan. 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). Puspan. L. 108–282, § 102(span)(5)(F)(i), substituted “360span 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 “360span of this title”.

Subsec. (f)(3). Puspan. L. 108–282, § 102(span)(5)(F)(ii), substituted “section 360span, 360ccc, or 360ccc–1” for “section 360span”.

2002—Subsec. (g)(1). Puspan. 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). Puspan. L. 107–250, § 204(1)(B), substituted “the agency center charged” for “the persons charged”.

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

Subsec. (g)(5). Puspan. 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. (span)(1)(A) to (C). Puspan. 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. (span)(3). Puspan. L. 105–115, § 126(c)(2), struck out reference to section 352(d) of this title before “355”.

Subsec. (span)(4). Puspan. 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). Puspan. 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). Puspan. 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). Puspan. 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). Puspan. 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). Puspan. L. 102–353, § 4(2), substituted “authorized distributor of record” for “distributor” wherever appearing.

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

Subsec. (e)(1). Puspan. 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 (span) 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). Puspan. 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). Puspan. L. 102–353, § 2(span), (d), temporarily added par. (3). Former par. (3) redesignated (4). See Termination Date of 1992 Amendment note below.

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

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

Subsec. (f)(1)(B). Puspan. 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). Puspan. L. 102–300 substituted “clearance” for “approval”.

1991—Subsec. (c). Puspan. 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). Puspan. L. 102–108, § 2(d)(1), made technical amendment to reference to subsection (span) of this section involving corresponding provision of original act.

Subsec. (d)(3)(E). Puspan. 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). Puspan. L. 102–108, § 2(d)(4), redesignated subsec. (f), relating to regulation of combination products, as (g).

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

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

1990—Puspan. 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). Puspan. L. 101–629, § 16(a)(2), added subsec. (f).

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

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

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

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

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

1962—Subsec. (span)(1)(C). Puspan. L. 87–781 substituted “approved” for “effective”.

1951—Subsec. (span). Act Oct. 26, 1951, amended subsec. (span) 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

Puspan. L. 113–54, title II, § 204(c), Nov. 27, 2013, 127 Stat. 636, provided that: “The amendments made by subsections (a) and (span) [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 Puspan. L. 105–115 effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Puspan. L. 105–115, set out as a note under section 321 of this title.

Termination Date of 1992 Amendment

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

Effective Date of 1988 Amendment

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

“(a)General Rule.—Except as provided in subsection (span), 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].

“(span)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 Puspan. 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 Puspan. 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 Puspan. L. 87–781 effective Oct. 10, 1962, see section 107 of Puspan. 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

Puspan. 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).

“(span)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 span, 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 span 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 (span) 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 (span).

“(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

Puspan. 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.