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21 U.S.C. § 353c — Prereview of television advertisements
Federal law — U.S. Code and appendices · legal_authorities
**(a) In general** The Secretary may require the submission of any television advertisement for a drug (including any script, story board, rough, or a completed video production of the television advertisement) to the Secretary for review under this section not later than 45 days before dissemination of the television advertisement.
**(b) Review** In conducting a review of a television advertisement under this section, the Secretary may make recommendations with respect to information included in the label of the drug—
(1) on changes that are—
(A) necessary to protect the consumer good and well-being; or
(B) consistent with prescribing information for the product under review; and
(2) if appropriate and if information exists, on statements for inclusion in the advertisement to address the specific efficacy of the drug as it relates to specific population groups, including elderly populations, children, and racial and ethnic minorities.
**(c) No authority to require changes** Except as provided by subsection (e), this section does not authorize the Secretary to make or direct changes in any material submitted pursuant to subsection (a).
**(d) Elderly populations, children, racially and ethnically diverse communities** In formulating recommendations under subsection (b), the Secretary shall take into consideration the impact of the advertised drug on elderly populations, children, and racially and ethnically diverse communities.
**(e) Specific disclosures**
(1) **Serious risk; safety protocol** — In conducting a review of a television advertisement under this section, if the Secretary determines that the advertisement would be false or misleading without a specific disclosure about a serious risk listed in the labeling of the drug involved, the Secretary may
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 353c
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Source file: Laws/federal/codes/united-states-code/title-21/section-353c-prereview-of-television-advertisements--22f4ebcc2b.md
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Source location: Title 21, Chapter 9, § 353c; chapter-009-federal-food-drug-and-cosmetic-act.md
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**(a) In general** The Secretary may require the submission of any television advertisement for a drug (including any script, story board, rough, or a completed video production of the television advertisement) to the Secretary for review under this section not later than 45 days before dissemination of the television advertisement.
**(b) Review** In conducting a review of a television advertisement under this section, the Secretary may make recommendations with respect to information included in the label of the drug—
(1) on changes that are—
(A) necessary to protect the consumer good and well-being; or
(B) consistent with prescribing information for the product under review; and
(2) if appropriate and if information exists, on statements for inclusion in the advertisement to address the specific efficacy of the drug as it relates to specific population groups, including elderly populations, children, and racial and ethnic minorities.
**(c) No authority to require changes** Except as provided by subsection (e), this section does not authorize the Secretary to make or direct changes in any material submitted pursuant to subsection (a).
**(d) Elderly populations, children, racially and ethnically diverse communities** In formulating recommendations under subsection (b), the Secretary shall take into consideration the impact of the advertised drug on elderly populations, children, and racially and ethnically diverse communities.
**(e) Specific disclosures**
(1) **Serious risk; safety protocol** — In conducting a review of a television advertisement under this section, if the Secretary determines that the advertisement would be false or misleading without a specific disclosure about a serious risk listed in the labeling of the drug involved, the Secretary may require inclusion of such disclosure in the advertisement.
(2) **Date of approval** — In conducting a review of a television advertisement under this section, the Secretary may require the advertisement to include, for a period not to exceed 2 years from the date of the approval of the drug under [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim) or [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim), a specific disclosure of such date of approval if the Secretary determines that the advertisement would otherwise be false or misleading.
**(f) Rule of construction** Nothing in this section may be construed as having any effect on requirements under [section 352(n) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section352/n&num=0&edition=prelim) or on the authority of the Secretary under section 314.550, 314.640, 601.45, or 601.94 of title 21, Code of Federal Regulations (or successor regulations).
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Necessity of effective approval of application** No person shall introduce or deliver for introduction into interstate commerce any new drug, unless an approval of an application filed pursuant to subsection (b) or (j) is effective with respect to such drug.
**(b) Filing application; contents**
(1)
(A) Any person may file with the Secretary an application with respect to any drug subject to the provisions of subsection (a). Such persons shall submit to the Secretary as part of the application—
(i) full reports of investigations which have been made to show whether such drug is safe for use and whether such drug is effective in use;
(ii) a full list of the articles used as components of such drug;
(iii) a full statement of the composition of such drug;
(iv) a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug;
(v) such samples of such drug and of the articles used as components thereof as the Secretary may require;
(vi) specimens of the labeling proposed to be used for such drug;
(vii) any assessments required under [section 355c of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355c&num=0&edition=prelim); and
(viii) the patent number and expiration date of each patent for which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner of the patent engaged in the manufacture, use, or sale of the drug, and that—
(I) claims the drug for which the applicant submitted the application and is a drug substance (active ingredient) patent or a drug product (formulation or composition) patent; or
(II) claims a method of using such drug for which approv
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 355
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Federal law — U.S. Code and appendices · legal_authorities
**(a) In general** Sections 352(f)(1), 355, and 360eee–1 of this title shall not apply to a drug compounded by or under the direct supervision of a licensed pharmacist in a facility that elects to register as an outsourcing facility if each of the following conditions is met:
(1) **Registration and reporting** — The drug is compounded in an outsourcing facility that is in compliance with the requirements of subsection (b).
(2) **Bulk drug substances** — The drug is compounded in an outsourcing facility that does not compound using bulk drug substances (as defined in section 207.3(a)(4) of title 21, Code of Federal Regulations (or any successor regulation)), unless—
(A)
(i) the bulk drug substance appears on a list established by the Secretary identifying bulk drug substances for which there is a clinical need, by—
(I) publishing a notice in the Federal Register proposing bulk drug substances to be included on the list, including the rationale for such proposal;
(II) providing a period of not less than 60 calendar days for comment on the notice; and
(III) publishing a notice in the Federal Register designating bulk drug substances for inclusion on the list; or
(ii) the drug compounded from such bulk drug substance appears on the drug shortage list in effect under [section 356e of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section356e&num=0&edition=prelim) at the time of compounding, distribution, and dispensing;
(B) if an applicable monograph exists under the United States Pharmacopeia, the National Formulary, or another compendium or pharmacopeia recognized by the Secretary for purposes of this paragraph, the bulk drug substances each comply with the monograph;
(C) the bulk drug substances a
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 353b
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Biologics license**
(1) No person shall introduce or deliver for introduction into interstate commerce any biological product unless—
(A) a biologics license under this subsection or subsection (k) is in effect for the biological product; and
(B) each package of the biological product is plainly marked with—
(i) the proper name of the biological product contained in the package;
(ii) the name, address, and applicable license number of the manufacturer of the biological product; and
(iii) the expiration date of the biological product.
(2)
(A) The Secretary shall establish, by regulation, requirements for the approval, suspension, and revocation of biologics licenses.
(B) *Pediatric studies.—* — A person that submits an application for a license under this paragraph shall submit to the Secretary as part of the application any assessments required under section 505B of the Federal Food, Drug, and Cosmetic Act [[21 U.S.C. 355c](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355c&num=0&edition=prelim)].
(C) The Secretary shall approve a biologics license application—
(i) on the basis of a demonstration that—
(I) the biological product that is the subject of the application is safe, pure, and potent; and
(II) the facility in which the biological product is manufactured, processed, packed, or held meets standards designed to assure that the biological product continues to be safe, pure, and potent; and
(ii) if the applicant (or other appropriate person) consents to the inspection of the facility that is the subject of the application, in accordance with subsection (c).
(D) *Postmarket studies and clinical trials; labeling; risk evaluation and mitigation strategy.—* — A person that sub
Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 262
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Federal law — U.S. Code and appendices · legal_authorities
The following acts and the causing thereof are prohibited:
**(a)** The introduction or delivery for introduction into interstate commerce of any food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded.
**(b)** The adulteration or misbranding of any food, drug, device, tobacco product, or cosmetic in interstate commerce.
**(c)** The receipt in interstate commerce of any food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded, and the delivery or proffered delivery thereof for pay or otherwise.
**(d)** The introduction or delivery for introduction into interstate commerce of any article in violation of section 344, 350d, 355,,11 So in original. 360bbb–3, or 364c of this title.
**(e)** The refusal to permit access to or copying of any record as required by section 350a, 350c, 350f(j), 350e, 354, 360bbb–3, 364a, 373, 374(a), 379aa, or 379aa–1 of this title; or the failure to establish or maintain any record, or make any report, required under section 350a, 350c(b), 350f, 350e, 354, 355(i) or (k), 360b(a)(4)(C), 360b(j), (l) or (m), 360ccc–1(i), 360e(f), 360i, 360bbb–3, 364a, 364g, 379aa, 379aa–1, 387i, or 387t of this title or the refusal to permit access to or verification or copying of any such required record; or the violation of any recordkeeping requirement under section 2223 22 See References in Text note below. of this title (except when such violation is committed by a farm).
**(f)** The refusal to permit entry or inspection as authorized by [section 374 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section374&num=0&edition=prelim).
**(g)** The manufacture within any Territory of any food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded.
*
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 331
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Violation of [section 331 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section331&num=0&edition=prelim); second violation; intent to defraud or mislead**
(1) Any person who violates a provision of [section 331 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section331&num=0&edition=prelim) shall be imprisoned for not more than one year or fined not more than $1,000, or both.
(2) Notwithstanding the provisions of paragraph (1) of this section,11 So in original. Words “of this section” probably should not appear. if any person commits such a violation after a conviction of him under this section has become final, or commits such a violation with the intent to defraud or mislead, such person shall be imprisoned for not more than three years or fined not more than $10,000, or both.
**(b) Prescription drug marketing violations**
(1) Notwithstanding subsection (a), any person who violates [section 331(t) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section331/t&num=0&edition=prelim) by—
(A) knowingly importing a drug in violation of [section 381(d)(1) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section381/d/1&num=0&edition=prelim),
(B) knowingly selling, purchasing, or trading a drug or drug sample or knowingly offering to sell, purchase, or trade a drug or drug sample, in violation of [section 353(c)(1) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section353/c/1&num=0&edition=prelim),
(C) knowingly selling, purchasing, or trading a coupon, knowingly offering to sell, purchase, or trade such a coupon, or knowingly counterfeiting such a coupon, in violation of [section
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 333
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Federal law — U.S. Code and appendices · legal_authorities
Page 182
TITLE 21—FOOD AND DRUGS
§ 353c
1 So in original.
2 So in original. Two subsecs. (d) have been enacted.
physicians with background and knowledge in
compounding, and patient and public health
advocacy organizations.
(3) Interim list
(A) In general
Before the effective date of the regulations
finalized to implement subsection (a)(6), the
Secretary may designate drugs, categories of
drugs, or conditions as described such 1 sub-
section by—
(i) publishing a notice of such sub-
stances, drugs, categories of drugs, or con-
ditions proposed for designation, including
the rationale for such designation, in the
Federal Register;
(ii) providing a period of not less than 60
calendar days for comment on the notice;
and
(iii) publishing a notice in the Federal
Register
designating
such
drugs,
cat-
egories of drugs, or conditions.
(B) Sunset of notice
Any notice provided under subparagraph
(A) shall not be effective after the earlier
of—
(i) the date that is 5 years after Novem-
ber 27, 2013; or
(ii) the effective date of the final regula-
tions issued to implement subsection
(a)(6).
(4) Updates
The Secretary shall review, and update as
necessary, the regulations containing the lists
of drugs, categories of drugs, or conditions de-
scribed in subsection (a)(6) regularly, but not
less than once every 4 years. Nothing in the
previous sentence prohibits submissions to the
Secretary, before or during any 4-year period
described in such sentence, requesting updates
to such lists.
(d) 2 Definitions
In this section:
(1) The term ‘‘compounding’’ includes the
combining, admixing, mixing, diluting, pool-
ing, reconstituting, or otherwise altering of a
drug or bulk drug substance to create a drug.
(2) The term ‘‘essentially a copy of an ap-
pro
Source: Supplied 2024 U.S. Code historical extraction · 21 U.S.C. § 353c
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