21 U.S.C. § 352 — Misbranded drugs and devices

Page 158 TITLE 21—FOOD AND DRUGS § 352 1 So in original. The term ‘‘health care economic information’’ appears only in par. (1). 1968—Par. (a). Pub. L. 90–399 added cls. (5) and (6). 1962—Par. (a). Pub. L. 87–781 designated existing pro- visions of cl. (2) as (A) and added (B). 1960—Par. (a). Pub. L. 86–618 substituted provisions in cl. (4) relating to unsafe color additives for provisions which related to a coal-tar color other than one from a batch that has been certified in accordance with regu- lations as provided by section 354 of this title. Statutory Notes and Related Subsidiaries EFFECTIVE AND TERMINATION DATES OF 1997 AMENDMENT Pub. L. 105–115, title I, § 121(b)(2), Nov. 21, 1997, 111 Stat. 2320, provided that: ‘‘Section 501(a)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351(a)(2)(C)) shall not apply 4 years after the date of en- actment of this Act [Nov. 21, 1997] or 2 years after the date on which the Secretary of Health and Human Services establishes the requirements described in sub- section (c)(1)(B) [section 121(c)(1)(B) of Pub. L. 105–115, set out as a note under section 355 of this title], which- ever is later.’’ 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 an Effective Date of 1997 Amendment note under section 321 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 sec- tion 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 1962 AMENDMENT; EXCEPTIONS Amendment by Pub. L. 87–781 effective on first day of seventh calendar month following October 1962, see sec- tion 107 of Pub. L. 87–781, set out as a note under sec- tion 321 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; POSTPONEMENT Par. (a)(4) effective Jan. 1, 1940, see act June 23, 1939, ch. 242, 53 Stat. 853, set out as an Effective Date; Post- ponement in Certain Cases note under section 301 of this title. APPROVAL BY REGULATION PRIOR TO JULY 9, 2012 Pub. L. 112–144, title VI, § 608(b)(3), July 9, 2012, 126 Stat. 1059, provided that: ‘‘The amendments made by this subsection [amending this section and section 360e of this title] shall have no effect on a regulation that was promulgated prior to the date of enactment of this Act [July 9, 2012] requiring that a device have an ap- proval under section 515 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e) of an application for pre- market approval.’’ GUIDANCE Pub. L. 112–144, title VII, § 707(b), July 9, 2012, 126 Stat. 1068, provided that: ‘‘Not later than 1 year after the date of enactment of this section [July 9, 2012], the Secretary of Health and Human Services shall issue guidance that defines the circumstances that would constitute delaying, denying, or limiting inspection, or refusing to permit entry or inspection, for purposes of section 501(j) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 351(j)] (as added by subsection (a)).’’ Executive Documents TRANSFER OF FUNCTIONS For transfer of functions of Federal Security Admin- istrator 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. § 352. Misbranded drugs and devices A drug or device shall be deemed to be mis- branded— (a) False or misleading label (1) If its labeling is false or misleading in any particular. Health care economic information provided to a payor, formulary committee, or other similar entity with knowledge and exper- tise in the area of health care economic anal- ysis, carrying out its responsibilities for the se- lection of drugs or devices for coverage or reim- bursement, shall not be considered to be false or misleading under this paragraph if the health care economic information relates to an indica- tion approved under section 355, 360(k), 360c(f)(2), or 360e of this title or section 262 of title 42 for such drug or device, is based on competent and reliable scientific evidence, and includes, where applicable, a conspicuous and prominent state- ment describing any material differences be- tween the health care economic information and the labeling approved for the drug or device under section 355, 360(k), 360c(f)(2), or 360e of this title or section 262 of title 42. The requirements set forth in section 355, 360(k), 360c(f)(2), or 360e of this title or section 262 of title 42 shall not apply to health care economic information pro- vided to such a payor, committee, or entity in accordance with this paragraph. Information that is relevant to the substantiation of the health care economic information presented pursuant to this paragraph shall be made avail- able to the Secretary upon request. (2)(A) For purposes of this paragraph,1 the term ‘‘health care economic information’’ means any analysis (including the clinical data, inputs, clinical or other assumptions, methods, results, and other components underlying or comprising the analysis) that identifies, meas- ures, or describes the economic consequences, which may be based on the separate or aggre- gated clinical consequences of the represented health outcomes, of the use of a drug or device. Such analysis may be comparative to the use of another drug or device, to another health care intervention, or to no intervention. (B) Such term does not include any analysis that relates only to an indication that is not ap- proved under section 355, 360(k), 360c(f)(2), or 360e of this title or section 262 of title 42 for such drug or device. (b) Package form; contents of label If in package form unless it bears a label con- taining (1) the name and place of business of the manufacturer, packer, or distributor; and (2) an accurate statement of the quantity of the con- tents in terms of weight, measure, or numerical count: Provided, That under clause (2) of this paragraph reasonable variations shall be per- mitted, and exemptions as to small packages shall be established, by regulations prescribed by the Secretary. Page 159 TITLE 21—FOOD AND DRUGS § 352 (c) Prominence of information on label If any word, statement, or other information required by or under authority of this chapter to appear on the label or labeling is not promi- nently placed thereon with such conspicuous- ness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and un- derstood by the ordinary individual under cus- tomary conditions of purchase and use. (d) Repealed. Pub. L. 105–115, title I, § 126(b), Nov. 21, 1997, 111 Stat. 2327 (e) Designation of drugs or devices by estab- lished names (1)(A) If it is a drug, unless its label bears, to the exclusion of any other nonproprietary name (except the applicable systematic chemical name or the chemical formula)— (i) the established name (as defined in sub- paragraph (3)) of the drug, if there is such a name; (ii) the established name and quantity or, if determined to be appropriate by the Sec- retary, the proportion of each active ingre- dient, including the quantity, kind, and pro- portion of any alcohol, and also including whether active or not the established name and quantity or if determined to be appro- priate by the Secretary, the proportion of any bromides, ether, chloroform, acetanilide, ace- tophenetidin, amidopyrine, antipyrine, atro- pine, hyoscine, hyoscyamine, arsenic, digi- talis, digitalis glucosides, mercury, ouabain, strophanthin, strychnine, thyroid, or any de- rivative or preparation of any such substances, contained therein, except that the require- ment for stating the quantity of the active in- gredients, other than the quantity of those specifically named in this subclause, shall not apply to nonprescription drugs not intended for human use; and (iii) the established name of each inactive ingredient listed in alphabetical order on the outside container of the retail package and, if determined to be appropriate by the Sec- retary, on the immediate container, as pre- scribed in regulation promulgated by the Sec- retary, except that nothing in this subclause shall be deemed to require that any trade se- cret be divulged, and except that the require- ments of this subclause with respect to alpha- betical order shall apply only to nonprescrip- tion drugs that are not also cosmetics and that this subclause shall not apply to non- prescription drugs not intended for human use. (B) For any prescription drug the established name of such drug or ingredient, as the case may be, on such label (and on any labeling on which a name for such drug or ingredient is used) shall be printed prominently and in type at least half as large as that used thereon for any proprietary name or designation for such drug or ingredient, except that to the extent that compliance with the requirements of sub- clause (ii) or (iii) of clause (A) or this clause is impracticable, exemptions shall be established by regulations promulgated by the Secretary. (2) If it is a device and it has an established name, unless its label bears, to the exclusion of any other nonproprietary name, its established name (as defined in subparagraph (4)) promi- nently printed in type at least half as large as that used thereon for any proprietary name or designation for such device, except that to the extent compliance with the requirements of this subparagraph is impracticable, exemptions shall be established by regulations promulgated by the Secretary. (3) As used in subparagraph (1), the term ‘‘es- tablished name’’, with respect to a drug or in- gredient thereof, means (A) the applicable offi- cial name designated pursuant to section 358 of this title, or (B), if there is no such name and such drug, or such ingredient, is an article rec- ognized in an official compendium, then the offi- cial title thereof in such compendium, or (C) if neither clause (A) nor clause (B) of this subpara- graph applies, then the common or usual name, if any, of such drug or of such ingredient, except that where clause (B) of this subparagraph ap- plies to an article recognized in the United States Pharmacopeia and in the Homoeopathic Pharmacopoeia under different official titles, the official title used in the United States Phar- macopeia shall apply unless it is labeled and of- fered for sale as a homoeopathic drug, in which case the official title used in the Homoeopathic Pharmacopoeia shall apply. (4) As used in subparagraph (2), the term ‘‘es- tablished name’’ with respect to a device means (A) the applicable official name of the device designated pursuant to section 358 of this title, (B) if there is no such name and such device is an article recognized in an official compendium, then the official title thereof in such compen- dium, or (C) if neither clause (A) nor clause (B) of this subparagraph applies, then any common or usual name of such device. (f) Directions for use and warnings on label Unless its labeling bears (1) adequate direc- tions for use; and (2) such adequate warnings against use in those pathological conditions or by children where its use may be dangerous to health, or against unsafe dosage or methods or duration of administration or application, in such manner and form, as are necessary for the protection of users, except that where any re- quirement of clause (1) of this paragraph, as ap- plied to any drug or device, is not necessary for the protection of the public health, the Sec- retary shall promulgate regulations exempting such drug or device from such requirement. Re- quired labeling for prescription devices intended for use in health care facilities or by a health care professional and required labeling for in vitro diagnostic devices intended for use by health care professionals or in blood establish- ments may be made available solely by elec- tronic means, provided that the labeling com- plies with all applicable requirements of law, and that the manufacturer affords such users the opportunity to request the labeling in paper form, and after such request, promptly provides the requested information without additional cost. (g) Representations as recognized drug; packing and labeling; inconsistent requirements for designation of drug If it purports to be a drug the name of which is recognized in an official compendium, unless Page 160 TITLE 21—FOOD AND DRUGS § 352 it is packaged and labeled as prescribed therein. The method of packing may be modified with the consent of the Secretary. Whenever a drug is recognized in both the United States Pharma- copoeia and the Homoeopathic Pharmacopoeia of the United States, it shall be subject to the requirements of the United States Pharma- copoeia with respect to packaging and labeling unless it is labeled and offered for sale as a homoeopathic drug, in which case it shall be subject to the provisions of the Homoeopathic Pharmacopoeia of the United States, and not those of the United States Pharmacopoeia, ex- cept that in the event of inconsistency between the requirements of this paragraph and those of paragraph (e) as to the name by which the drug or its ingredients shall be designated, the re- quirements of paragraph (e) shall prevail. (h) Deteriorative drugs; packing and labeling If it has been found by the Secretary to be a drug liable to deterioration, unless it is pack- aged in such form and manner, and its label bears a statement of such precautions, as the Secretary shall by regulations require as nec- essary for the protection of the public health. No such regulation shall be established for any drug recognized in an official compendium until the Secretary shall have informed the appro- priate body charged with the revision of such compendium of the need for such packaging or labeling requirements and such body shall have failed within a reasonable time to prescribe such requirements. (i) Drug; misleading container; imitation; offer for sale under another name (1) If it is a drug and its container is so made, formed, or filled as to be misleading; or (2) if it is an imitation of another drug; or (3) if it is of- fered for sale under the name of another drug. (j) Health-endangering when used as prescribed If it is dangerous to health when used in the dosage or manner, or with the frequency or du- ration prescribed, recommended, or suggested in the labeling thereof. (k), (l) Repealed. Pub. L. 105–115, title I, § 125(a)(2)(B), (b)(2)(D), Nov. 21, 1997, 111 Stat. 2325 (m) Color additives; packing and labeling If it is a color additive the intended use of which is for the purpose of coloring only, unless its packaging and labeling are in conformity with such packaging and labeling requirements applicable to such color additive, as may be con- tained in regulations issued under section 379e of this title. (n) Prescription drug advertisements: estab- lished name; quantitative formula; side ef- fects, contraindications, and effectiveness; prior approval; false advertising; labeling; construction of the Convention on Psycho- tropic Substances In the case of any prescription drug distrib- uted or offered for sale in any State, unless the manufacturer, packer, or distributor thereof in- cludes in all advertisements and other descrip- tive printed matter issued or caused to be issued by the manufacturer, packer, or distributor with respect to that drug a true statement of (1) the established name as defined in paragraph (e), printed prominently and in type at least half as large as that used for any trade or brand name thereof, (2) the formula showing quantitatively each ingredient of such drug to the extent re- quired for labels under paragraph (e), and (3) such other information in brief summary relat- ing to side effects, contraindications, and effec- tiveness as shall be required in regulations which shall be issued by the Secretary in ac- cordance with section 371(a) of this title, and in the case of published direct-to-consumer adver- tisements the following statement printed in conspicuous text: ‘‘You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1–800- FDA-1088.’’, except that (A) except in extraor- dinary circumstances, no regulation issued under this paragraph shall require prior ap- proval by the Secretary of the content of any advertisement, and (B) no advertisement of a prescription drug, published after the effective date of regulations issued under this paragraph applicable to advertisements of prescription drugs, shall with respect to the matters speci- fied in this paragraph or covered by such regula- tions, be subject to the provisions of sections 52 to 57 of title 15. This paragraph (n) shall not be applicable to any printed matter which the Sec- retary determines to be labeling as defined in section 321(m) of this title. Nothing in the Con- vention on Psychotropic Substances, signed at Vienna, Austria, on February 21, 1971, shall be construed to prevent drug price communications to consumers. In the case of an advertisement for a drug subject to section 353(b)(1) of this title presented directly to consumers in television or radio format and stating the name of the drug and its conditions of use, the major statement relating to side effects and contraindications shall be presented in a clear, conspicuous, and neutral manner. (o) Drugs or devices from nonregistered estab- lishments If it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 360 of this title, if it is a drug and was imported or offered for import by a commercial importer of drugs not duly registered under section 381(s) of this title, if it was not included in a list required by section 360(j) of this title, if a notice or other in- formation respecting it was not provided as re- quired by such section or section 360(k) of this title, or if it does not bear such symbols from the uniform system for identification of devices prescribed under section 360(e) of this title as the Secretary by regulation requires. (p) Packaging or labeling of drugs in violation of regulations If it is a drug and its packaging or labeling is in violation of an applicable regulation issued pursuant to section 1472 or 1473 of title 15. (q) Restricted devices using false or misleading advertising or used in violation of regula- tions In the case of any restricted device distributed or offered for sale in any State, if (1) its adver- Page 161 TITLE 21—FOOD AND DRUGS § 352 tising is false or misleading in any particular, or (2) it is sold, distributed, or used in violation of regulations prescribed under section 360j(e) of this title. (r) Restricted devices not carrying requisite ac- companying statements in advertisements and other descriptive printed matter In the case of any restricted device distributed or offered for sale in any State, unless the man- ufacturer, packer, or distributor thereof in- cludes in all advertisements and other descrip- tive printed matter issued or caused to be issued by the manufacturer, packer, or distributor with respect to that device (1) a true statement of the device’s established name as defined in sub- section (e), printed prominently and in type at least half as large as that used for any trade or brand name thereof, and (2) a brief statement of the intended uses of the device and relevant warnings, precautions, side effects, and contra- indications and, in the case of specific devices made subject to a finding by the Secretary after notice and opportunity for comment that such action is necessary to protect the public health, a full description of the components of such de- vice or the formula showing quantitatively each ingredient of such device to the extent required in regulations which shall be issued by the Sec- retary after an opportunity for a hearing. Ex- cept in extraordinary circumstances, no regula- tion issued under this paragraph shall require prior approval by the Secretary of the content of any advertisement and no advertisement of a restricted device, published after the effective date of this paragraph shall, with respect to the matters specified in this paragraph or covered by regulations issued hereunder, be subject to the provisions of sections 52 through 55 of title 15. This paragraph shall not be applicable to any printed matter which the Secretary determines to be labeling as defined in section 321(m) of this title. (s) Devices subject to performance standards not bearing requisite labeling If it is a device subject to a performance standard established under section 360d of this title, unless it bears such labeling as may be prescribed in such performance standard. (t) Devices for which there has been a failure or refusal to give required notification or to furnish required material or information If it is a device and there was a failure or re- fusal (1) to comply with any requirement pre- scribed under section 360h of this title respect- ing the device, (2) to furnish any material or in- formation required by or under section 360i of this title respecting the device, or (3) to comply with a requirement under section 360l of this title. (u) Identification of manufacturer (1) Subject to paragraph (2), if it is a reproc- essed single-use device, unless it, or an attach- ment thereto, prominently and conspicuously bears the name of the manufacturer of the re- processed device, a generally recognized abbre- viation of such name, or a unique and generally recognized symbol identifying such manufac- turer. (2) If the original device or an attachment thereto does not prominently and conspicuously bear the name of the manufacturer of the origi- nal device, a generally recognized abbreviation of such name, or a unique and generally recog- nized symbol identifying such manufacturer, a reprocessed device may satisfy the requirements of paragraph (1) through the use of a detachable label on the packaging that identifies the manu- facturer and is intended to be affixed to the medical record of a patient. (v) Reprocessed single-use devices If it is a reprocessed single-use device, unless all labeling of the device prominently and con- spicuously bears the statement ‘‘Reprocessed de- vice for single use. Reprocessed by ll.’’ The name of the manufacturer of the reprocessed de- vice shall be placed in the space identifying the person responsible for reprocessing. (w) New animal drugs If it is a new animal drug— (1) that is conditionally approved under sec- tion 360ccc of this title and its labeling does not conform with the approved application or section 360ccc(f) of this title, or that is not conditionally approved under section 360ccc of this title and its label bears the statement set forth in section 360ccc(f)(1)(A) of this title; (2) that is indexed under section 360ccc–1 of this title and its labeling does not conform with the index listing under section 360ccc–1(e) of this title or 360ccc–1(h) of this title, or that has not been indexed under section 360ccc–1 of this title and its label bears the statement set forth in section 360ccc–1(h) of this title; or (3) for which an application has been ap- proved under section 360b of this title and the labeling of such drug does not include the ap- plication number in the format: ‘‘Approved by FDA under (A)NADA # xxx–xxx’’, except that this subparagraph shall not apply to rep- resentative labeling required under section 514.1(b)(3)(v)(b) of title 21, Code of Federal Reg- ulations (or any successor regulation) for ani- mal feed bearing or containing a new animal drug. (x) Nonprescription drugs If it is a nonprescription drug (as defined in section 379aa of this title) that is marketed in the United States, unless the label of such drug includes a domestic address or domestic phone number through which the responsible person (as described in section 379aa of this title) may receive a report of a serious adverse event (as defined in section 379aa of this title) with such drug. (y) Drugs subject to approved risk evaluation and mitigation strategy If it is a drug subject to an approved risk eval- uation and mitigation strategy pursuant to sec- tion 355(p) of this title and the responsible per- son (as such term is used in section 355–1 of this title) fails to comply with a requirement of such strategy provided for under subsection (d), (e), or (f) of section 355–1 of this title. (z) Postmarket studies and clinical trials; new safety information in labeling If it is a drug, and the responsible person (as such term is used in section 355(o) of this title) Page 162 TITLE 21—FOOD AND DRUGS § 352 is in violation of a requirement established under paragraph (3) (relating to postmarket studies and clinical trials) or paragraph (4) (re- lating to labeling) of section 355(o) of this title with respect to such drug. (aa) Unpaid fees; failure to submit identifying in- formation If it is a drug, or an active pharmaceutical in- gredient, and it was manufactured, prepared, propagated, compounded, or processed in a facil- ity for which fees have not been paid as required by section 379j–42(a)(4) of this title or for which identifying information required by section 379j–42(f) of this title has not been submitted, or it contains an active pharmaceutical ingredient that was manufactured, prepared, propagated, compounded, or processed in such a facility. (bb) False or misleading advertisement or pro- motion of compounded drug If the advertising or promotion of a com- pounded drug is false or misleading in any par- ticular. (cc) Failure to bear product identifier If it is a drug and it fails to bear the product identifier as required by section 360eee–1 of this title. (dd) Improper labeling of antimicrobial drugs If it is an antimicrobial drug, as defined in section 360a–2(f) of this title, and its labeling fails to conform with the requirements under section 360a–2(d) of this title. (ee) Nonprescription drug subject to regulation If it is a nonprescription drug that is subject to section 355h of this title, is not the subject of an application approved under section 355 of this title, and does not comply with the require- ments under section 355h of this title. (ff) Drugs manufactured, prepared, propagated, compounded, or processed in facilities for which fees have not been paid If it is a drug and it was manufactured, pre- pared, propagated, compounded, or processed in a facility for which fees have not been paid as required by section 379j–72 of this title. (gg) Product information prior to approval (1) Unless its labeling bears adequate direc- tions for use in accordance with paragraph (f), except that (in addition to drugs or devices that conform with exemptions pursuant to such para- graph) no drug or device shall be deemed to be misbranded under such paragraph through the provision of truthful and not misleading product information to a payor, formulary committee, or other similar entity with knowledge and ex- pertise in the area of health care economic anal- ysis carrying out its responsibilities for the se- lection of drugs or devices for coverage or reim- bursement if the product information relates to an investigational drug or device or investiga- tional use of a drug or device that is approved, cleared, granted marketing authorization, or li- censed under section 355, 360(k), 360c(f)(2), or 360e of this title or section 262 of title 42 (as applica- ble), provided— (A) the product information includes— (i) a clear statement that the investiga- tional drug or device or investigational use of a drug or device has not been approved, cleared, granted marketing authorization, or licensed under section 355, 360(k), 360c(f)(2), or 360e of this title or section 262 of title 42 (as applicable) and that the safety and effec- tiveness of such drug or device for such use has not been established; (ii) information related to the stage of de- velopment of the drug or device involved, such as— (I) the status of any study or studies in which the investigational drug or device or investigational use is being investigated; (II) how the study or studies relate to the overall plan for the development of the drug or device; and (III) whether an application, premarket notification, or request for classification for the investigational drug or device or investigational use has been submitted to the Secretary and when such a submission is planned; (iii) in the case of information that in- cludes factual presentations of results from studies, which shall not be selectively pre- sented, a description of— (I) all material aspects of study design, methodology, and results; and (II) all material limitations related to the study design, methodology, and re- sults; (iv) where applicable, a prominent state- ment disclosing the indication or indications for which the Secretary has approved, grant- ed marketing authorization, cleared, or li- censed the product pursuant to section 355, 360(k), 360c(f)(2), or 360e of this title or sec- tion 262 of title 42, and a copy of the most current required labeling; and (v) updated information, if previously com- municated information becomes materially outdated as a result of significant changes or as a result of new information regarding the product or its review status; and (B) the product information does not in- clude— (i) information that represents that an un- approved product— (I) has been approved, cleared, granted marketing authorization, or licensed under section 355, 360(k), 360c(f)(2), or 360e of this title or section 262 of title 42 (as ap- plicable); or (II) has otherwise been determined to be safe or effective for the purpose or pur- poses for which the drug or device is being studied; or (ii) information that represents that an unapproved use of a drug or device that has been so approved, granted marketing au- thorization, cleared, or licensed— (I) is so approved, granted marketing au- thorization, cleared, or licensed; or (II) that the product is safe or effective for the use or uses for which the drug or device is being studied. (2) For purposes of this paragraph, the term ‘‘product information’’ includes— (A) information describing the drug or de- vice (such as drug class, device description, and features); Page 163 TITLE 21—FOOD AND DRUGS § 352 (B) information about the indication or indi- cations being investigated; (C) the anticipated timeline for a possible approval, clearance, marketing authorization, or licensure pursuant to section 355, 360(k), 360c, or 360e of this title or section 262 of title 42; (D) drug or device pricing information; (E) patient utilization projections; (F) product-related programs or services; and (G) factual presentations of results from studies that do not characterize or make con- clusions regarding safety or efficacy. (June 25, 1938, ch. 675, § 502, 52 Stat. 1050; June 23, 1939, ch. 242, § 3, 53 Stat. 854; Dec. 22, 1941, ch. 613, § 2, 55 Stat. 851; July 6, 1945, ch. 281, § 2, 59 Stat. 463; Mar. 10, 1947, ch. 16, § 2, 61 Stat. 11; July 13, 1949, ch. 305, § 1, 63 Stat. 409; Aug. 5, 1953, ch. 334, § 1, 67 Stat. 389; Pub. L. 86–618, title I, § 102(b)(2), July 12, 1960, 74 Stat. 398; Pub. L. 87–781, title I, §§ 105(c), 112(a), (b), 131(a), title III, § 305, Oct. 10, 1962, 76 Stat. 785, 790, 791, 795; Pub. L. 90–399, § 105(a), July 13, 1968, 82 Stat. 352; Pub. L. 91–601, § 6(d), formerly § 7(d), Dec. 30, 1970, 84 Stat. 1673, renumbered Pub. L. 97–35, title XII, § 1205(c), Aug. 13, 1981, 95 Stat. 716; Pub. L. 94–295, §§ 3(e), 4(b)(2), 5(a), 9(b)(2), May 28, 1976, 90 Stat. 577, 580, 583; Pub. L. 95–633, title I, § 111, Nov. 10, 1978, 92 Stat. 3773; Pub. L. 102–300, § 3(a)(2), June 16, 1992, 106 Stat. 239; Pub. L. 102–571, title I, § 107(9), Oct. 29, 1992, 106 Stat. 4499; Pub. L. 103–80, § 3(m), Aug. 13, 1993, 107 Stat. 777; Pub. L. 105–115, title I, §§ 114(a), 125(a)(2)(B), (b)(2)(D), 126(b), title IV, § 412(c), Nov. 21, 1997, 111 Stat. 2312, 2325, 2327, 2375; Pub. L. 107–250, title II, § 206, title III, §§ 301(a), 302(a)(1), Oct. 26, 2002, 116 Stat. 1613, 1616; Pub. L. 108–214, § 2(b)(2)(B), Apr. 1, 2004, 118 Stat. 575; Pub. L. 108–282, title I, § 102(b)(5)(E), Aug. 2, 2004, 118 Stat. 902; Pub. L. 109–43, § 2(c)(1), Aug. 1, 2005, 119 Stat. 441; Pub. L. 109–462, § 2(d), Dec. 22, 2006, 120 Stat. 3472; Pub. L. 110–85, title IX, §§ 901(d)(3)(A), (6), 902(a), 906(a), Sept. 27, 2007, 121 Stat. 940, 942, 943, 949; Pub. L. 112–144, title III, § 306, title VII, §§ 702(a), 714(c), July 9, 2012, 126 Stat. 1024, 1065, 1074; Pub. L. 112–193, § 2(a), Oct. 5, 2012, 126 Stat. 1443; Pub. L. 113–54, title I, § 103(b), title II, § 206(b), Nov. 27, 2013, 127 Stat. 597, 639; Pub. L. 114–255, div. A, title III, §§ 3037, 3044(b)(2), Dec. 13, 2016, 130 Stat. 1105, 1121; Pub. L. 115–234, title III, § 303(a), Aug. 14, 2018, 132 Stat. 2436; Pub. L. 116–136, div. A, title III, § 3852, Mar. 27, 2020, 134 Stat. 454; Pub. L. 117–328, div. FF, title III, § 3630(a), Dec. 29, 2022, 136 Stat. 5893.) Editorial Notes AMENDMENTS 2022—Subsec. (a)(1). Pub. L. 117–328, § 3630(a)(1)–(3), substituted ‘‘drugs or devices for coverage’’ for ‘‘drugs for coverage’’, ‘‘drug or device’’ for ‘‘drug’’ in two places, ‘‘under section 355 of this title or under section 262(a) of title 42’’ for ‘‘under section 355 of this title or under section 262(a) of title 42’’, ‘‘under section 355, 360(k), 360c(f)(2), or 360e of this title or section 262 of title 42’’ for ‘‘under section 355 of this title or under section 262 of title 42’’, and ‘‘in section 355, 360(k), 360c(f)(2), or 360e of this title or section 262 of title 42’’ for ‘‘in section 355(a) of this title or in subsections (a) and (k) of section 262 of title 42’’. Subsec. (a)(2)(A). Pub. L. 117–328, § 3630(a)(1)(B), sub- stituted ‘‘drug or device’’ for ‘‘drug’’ in two places. Subsec. (a)(2)(B). Pub. L. 117–328, § 3630(a)(1)(B), (2), substituted ‘‘drug or device’’ for ‘‘drug’’ and ‘‘under section 355, 360(k), 360c(f)(2), or 360e of this title or sec- tion 262 of title 42’’ for ‘‘under section 355 of this title or under section 262 of title 42’’. Subsec. (gg). Pub. L. 117–328, § 3630(a)(4), added subsec. (gg). 2020—Subsecs. (ee), (ff). Pub. L. 116–136 added subsecs. (ee) and (ff). 2018—Subsec. (w)(3). Pub. L. 115–234 added par. (3). 2016—Subsec. (a). Pub. L. 114–255, § 3037, designated ex- isting provisions as par. (1), substituted ‘‘a payor, for- mulary committee, or other similar entity with knowl- edge and expertise in the area of health care economic analysis, carrying out its responsibilities for the selec- tion of drugs for coverage or reimbursement’’ for ‘‘a formulary committee, or other similar entity, in the course of the committee or the entity carrying out its responsibilities for the selection of drugs for managed care or other similar organizations’’, ‘‘relates’’ for ‘‘di- rectly relates’’, and ‘‘, is based on competent and reli- able scientific evidence, and includes, where applicable, a conspicuous and prominent statement describing any material differences between the health care economic information and the labeling approved for the drug under section 355 of this title or under section 262 of title 42. The requirements set forth in section 355(a) of this title or in subsections (a) and (k) of section 262 of title 42 shall not apply to health care economic infor- mation provided to such a payor, committee, or entity in accordance with this paragraph’’ for ‘‘and is based on competent and reliable scientific evidence. The require- ments set forth in section 355(a) of this title or in sec- tion 262(a) of title 42 shall not apply to health care eco- nomic information provided to such a committee or en- tity in accordance with this paragraph’’, struck out ‘‘In this paragraph, the term ‘health care economic infor- mation’ means any analysis that identifies, measures, or compares the economic consequences, including the costs of the represented health outcomes, of the use of a drug to the use of another drug, to another health care intervention, or to no intervention.’’ at end, and added par. (2). Subsec. (dd). Pub. L. 114–255, § 3044(b)(2), added subsec. (dd). 2013—Par. (bb). Pub. L. 113–54, § 103(b), added par. (bb). Par. (cc). Pub. L. 113–54, § 206(b), added par. (cc). 2012—Par. (o). Pub. L. 112–144, § 714(c), inserted ‘‘if it is a drug and was imported or offered for import by a commercial importer of drugs not duly registered under section 381(s) of this title,’’ after ‘‘not duly reg- istered under section 360 of this title,’’. Pub. L. 112–144, § 702(a), struck out ‘‘in any State’’ after ‘‘establishment’’. Par. (aa). Pub. L. 112–193 substituted ‘‘379j–42(a)(4)’’ for ‘‘379j–41(a)(4)’’. Pub. L. 112–144, § 306, added par. (aa). 2007—Par. (n). Pub. L. 110–85, § 906(a), inserted ‘‘and in the case of published direct-to-consumer advertise- ments the following statement printed in conspicuous text: ‘You are encouraged to report negative side ef- fects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1–800-FDA-1088.’,’’ after ‘‘section 371(a) of this title,’’. Pub. L. 110–85, § 901(d)(6), substituted ‘‘section 371(a) of this title’’ for ‘‘the procedure specified in section 371(e) of this title’’. Pub. L. 110–85, § 901(d)(3)(A), inserted at end ‘‘In the case of an advertisement for a drug subject to section 353(b)(1) of this title presented directly to consumers in television or radio format and stating the name of the drug and its conditions of use, the major statement re- lating to side effects and contraindications shall be presented in a clear, conspicuous, and neutral manner.’’ Pars. (y), (z). Pub. L. 110–85, § 902(a), added pars. (y) and (z). 2006—Par. (x). Pub. L. 109–462 added par. (x). 2005—Par. (u). Pub. L. 109–43 amended par. (u) gen- erally. Prior to amendment, par. (u) read as follows: ‘‘If it is a device, unless it, or an attachment thereto, Page 164 TITLE 21—FOOD AND DRUGS § 352 prominently and conspicuously bears the name of the manufacturer of the device, a generally recognized ab- breviation of such name, or a unique and generally rec- ognized symbol identifying such manufacturer, except that the Secretary may waive any requirement under this paragraph for the device if the Secretary deter- mines that compliance with the requirement is not fea- sible for the device or would compromise the provision of reasonable assurance of the safety or effectiveness of the device.’’ 2004—Par. (f). Pub. L. 108–214, in last sentence, in- serted ‘‘or by a health care professional and required labeling for in vitro diagnostic devices intended for use by health care professionals or in blood establish- ments’’ after ‘‘in health care facilities’’, inserted comma after ‘‘means’’, substituted ‘‘requirements of law, and that the manufacturer affords such users the opportunity’’ for ‘‘requirements of law and, that the manufacturer affords health care facilities the oppor- tunity’’, and struck out ‘‘the health care facility’’ after ‘‘promptly provides’’. Par. (w). Pub. L. 108–282 added par. (w). 2002—Par. (f). Pub. L. 107–250, § 206, inserted at end ‘‘Required labeling for prescription devices intended for use in health care facilities may be made available solely by electronic means provided that the labeling complies with all applicable requirements of law and, that the manufacturer affords health care facilities the opportunity to request the labeling in paper form, and after such request, promptly provides the health care facility the requested information without additional cost.’’ Par. (u). Pub. L. 107–250, § 301(a), which directed amendment of section by adding par. (u) at end, was ex- ecuted by adding par. (u) before par. (v) to reflect the probable intent of Congress. Par. (v). Pub. L. 107–250, § 302(a)(1), added par. (v). 1997—Par. (a). Pub. L. 105–115, § 114(a), inserted at end ‘‘Health care economic information provided to a for- mulary committee, or other similar entity, in the course of the committee or the entity carrying out its responsibilities for the selection of drugs for managed care or other similar organizations, shall not be consid- ered to be false or misleading under this paragraph if the health care economic information directly relates to an indication approved under section 355 of this title or under section 262(a) of title 42 for such drug and is based on competent and reliable scientific evidence. The requirements set forth in section 355(a) of this title or in section 262(a) of title 42 shall not apply to health care economic information provided to such a com- mittee or entity in accordance with this paragraph. In- formation that is relevant to the substantiation of the health care economic information presented pursuant to this paragraph shall be made available to the Sec- retary upon request. In this paragraph, the term ‘health care economic information’ means any analysis that identifies, measures, or compares the economic consequences, including the costs of the represented health outcomes, of the use of a drug to the use of an- other drug, to another health care intervention, or to no intervention.’’ Par. (d). Pub. L. 105–115, § 126(b), struck out par. (d) which read as follows: ‘‘If it is for use by man and con- tains any quantity of the narcotic or hypnotic sub- stance alpha eucaine, barbituric acid, betaeucaine, bromal, cannabis, carbromal, chloral, coca, cocaine, co- deine, heroin, marihuana, morphine, opium, par- aldehyde, peyote, or sulphonmethane; or any chemical derivative of such substance, which derivative has been by the Secretary, after investigation, found to be, and by regulations designated as, habit forming; unless its label bears the name and quantity or proportion of such substance or derivative and in juxtaposition therewith the statement ‘Warning—May be habit form- ing.’ ’’ Par. (e)(1). Pub. L. 105–115, § 412(c), amended subpar. (1) generally. Prior to amendment, subpar. (1) read as follows: ‘‘If it is a drug, unless (A) its label bears, to the exclusion of any other nonproprietary name (except the applicable systematic chemical name or the chemical formula), (i) the established name (as defined in sub- paragraph (3)) of the drug, if such there be, and (ii), in case it is fabricated from two or more ingredients, the established name and quantity of each active ingre- dient, including the quantity, kind, and proportion of any alcohol, and also including, whether active or not, the established name and quantity or proportion of any bromides, ether, chloroform, acetanilid, acetphenetidin, amidopyrine, antipyrine, atropine, hyoscine, hyoscyamine, arsenic, digitalis, digitalis glucosides, mercury ouabain strophanthin, strychnine, thyroid, or any derivative or preparation of any such substances, contained therein; Provided, That the re- quirement for stating the quantity of the active ingre- dients, other than the quantity of those specifically named in this paragraph, shall apply only to prescrip- tion drugs; and (B) for any prescription drug the estab- lished name of such drug or ingredient, as the case may be, on such label (and on any labeling on which a name for such drug or ingredient is used) is printed promi- nently and in type at least half as large as that used thereon for any proprietary name or designation for such drug or ingredient: Provided, That to the extent that compliance with the requirements of clause (A)(ii) or clause (B) of this subparagraph is impracticable, ex- emptions shall be established by regulations promul- gated by the Secretary.’’ Par. (k). Pub. L. 105–115, § 125(a)(2)(B), struck out par. (k) which read as follows: ‘‘If it is, or purports to be, or is represented as a drug composed wholly or partly of insulin, unless (1) it is from a batch with respect to which a certificate or release has been issued pursuant to section 356 of this title, and (2) such certificate or re- lease is in effect with respect to such drug.’’ Par. (l). Pub. L. 105–115, § 125(b)(2)(D), struck out par. (l) which read as follows: ‘‘If it is, or purports to be, or is represented as a drug (except a drug for use in ani- mals other than man) composed wholly or partly of any kind of penicillin, streptomycin, chlortetracycline, chloramphenicol, bacitracin, or any other antibiotic drug, or any derivative thereof, unless (1) it is from a batch with respect to which a certificate or release has been issued pursuant to section 357 of this title, and (2) such certificate or release is in effect with respect to such drug: Provided, That this paragraph shall not apply to any drug or class of drugs exempted by regula- tions promulgated under section 357(c) or (d) of this title.’’ 1993—Par. (e)(3). Pub. L. 103–80, § 3(m)(1), substituted ‘‘of such ingredient, except that’’ for ‘‘of such ingre- dient: Provided, That’’. Par. (f). Pub. L. 103–80, § 3(m)(2), substituted ‘‘users, except that where’’ for ‘‘users: Provided, That where’’. Par. (g). Pub. L. 103–80, § 3(m)(3), substituted ‘‘pre- scribed therein. The method’’ for ‘‘prescribed therein: Provided, That the method’’ and ‘‘Pharmacopoeia, ex- cept that’’ for ‘‘Pharmacopoeia: Provided further, That,’’. Par. (n). Pub. L. 103–80, § 3(m)(4), substituted ‘‘, except that (A)’’ for ‘‘: Provided, That (A)’’. 1992—Par. (m). Pub. L. 102–571 substituted ‘‘379e’’ for ‘‘376’’. Par. (t)(3). Pub. L. 102–300 added cl. (3). 1978—Par. (n). Pub. L. 95–633 inserted provision relat- ing to the construction of the Convention on Psycho- tropic Substances. 1976—Par. (e). Pub. L. 94–295, § 5(a), substituted ‘‘sub- paragraph (3)’’ for ‘‘subparagraph (2)’’ in subpar. (1), added subpar. (2), redesignated former subpar. (2) as (3) and in subpar. (3) as so redesignated substituted ‘‘sub- paragraph (1)’’ for ‘‘this paragraph (e)’’, and added sub- par. (4). Par. (j). Pub. L. 94–295, § 3(e)(2), substituted ‘‘dosage or manner,’’ for ‘‘dosage,’’. Par. (m). Pub. L. 94–295, § 9(b)(2), substituted ‘‘the in- tended use of which is for’’ for ‘‘the intended use of which in or on drugs is for’’. Par. (o). Pub. L. 94–295, § 4(b)(2), substituted ‘‘If it was manufactured’’ for ‘‘If it is a drug and was manufac- Page 165 TITLE 21—FOOD AND DRUGS § 352 tured’’ and inserted ‘‘, if it was not included in a list required by section 360(j) of this title, if a notice or other information respecting it was not provided as re- quired by such section or section 360(k) of this title, or if it does not bear such symbols from the uniform sys- tem for identification of devices prescribed under sec- tion 360(e) of this title as the Secretary by regulation requires’’. Pars. (q) to (t). Pub. L. 94–295, § 3(e)(1), added pars. (q) to (t). 1970—Par. (p). Pub. L. 91–601 added par. (p). 1968—Par. (l). Pub. L. 90–399 inserted ‘‘(except a drug for use in animals other than man)’’ after ‘‘represented as a drug’’. 1962—Par. (e). Pub. L. 87–781, § 112(a), designated exist- ing provisions as subpar. (1), substituted ‘‘, unless (A) its label bears, to the exclusion of any other nonpropri- etary name (except the applicable systematic chemical name or the chemical formula), (i) the established name (as defined in subparagraph (2) of this subsection) of the drug, if such there be, and (ii), in case it is fab- ricated from two or more ingredients, the established name and quantity’’ for ‘‘and is not designated solely by a name recognized in an official compendium unless its label bears (1) the common or usual name of the drug, if such there be; and (2), in case it is fabricated from two or more ingredients, the common or usual name’’, and ‘‘the established name’’ for ‘‘the name’’, provided that the requirement for stating the quantity of active ingredients, other than those specified in this par., applies only to prescription drugs, and that the es- tablished name of a drug on a label is to be printed prominently and in type at least half as large as used for any proprietary designation, and added subpar. (2) defining ‘‘established name’’. Par. (g). Pub. L. 87–781, § 112(b), provided that if there is an inconsistency between the provisions of this par. and those of par. (e), as to the name of a drug, the re- quirements of par. (e) should prevail. Par. (l). Pub. L. 87–781, § 105(c), substituted ‘‘baci- tracin, or any other antibiotic drug’’ for ‘‘or baci- tracin.’’ Par. (n). Pub. L. 87–781, § 131(a), added par. (n). Par. (o). Pub. L. 87–781, § 305, added par. (o). 1960—Par. (m). Pub. L. 86–618 added par. (m). 1953—Par. (l). Act Aug. 5, 1953, substituted ‘‘chlor- tetracycline’’ for ‘‘aureomycin’’. 1949—Par. (l). Act July 13, 1949, inserted ‘‘, aureomycin, chloramphenicol, or bacitracin’’ after ‘‘streptomycin’’. 1947—Par. (l). Act Mar. 10, 1947, inserted ‘‘or strepto- mycin’’ after ‘‘penicillin’’. 1945—Par. (l). Act July 6, 1945, added par. (l). 1941—Par. (k). Act Dec. 22, 1941, added par. (k). 1939—Par. (d). Act June 29, 1939, substituted ‘‘name, and quality or proportion’’ for ‘‘name, quantity, and percentage’’. Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 2018 AMENDMENT Pub. L. 115–234, title III, § 303(b), Aug. 14, 2018, 132 Stat. 2436, provided that: ‘‘Section 502(w)(3) of the Fed- eral Food, Drug, and Cosmetic Act [21 U.S.C. 352(w)(3)], as added by subsection (a), shall apply beginning on September 30, 2023.’’ EFFECTIVE DATE OF 2012 AMENDMENT Amendment by section 306 of Pub. L. 112–144 effective Oct. 1, 2012, see section 305 of Pub. L. 112–144, set out as an Effective and Termination Dates note under section 379j–41 of this title. EFFECTIVE DATE OF 2007 AMENDMENT Amendment by Pub. L. 110–85 effective 180 days after Sept. 27, 2007, see section 909 of Pub. L. 110–85, set out as a note under section 331 of this title. EFFECTIVE DATE OF 2006 AMENDMENT Pub. L. 109–462, § 2(e)(1), (2), Dec. 22, 2006, 120 Stat. 3472, provided that: ‘‘(1) IN GENERAL.—Except as provided in paragraph (2), the amendments made by this section [enacting section 379aa of this title and amending this section and sec- tion 331 of this title] shall take effect 1 year after the date of enactment of this Act [Dec. 22, 2006]. ‘‘(2) MISBRANDING.—Section 502(x) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 352(x)] (as added by this section) shall apply to any nonprescrip- tion drug (as defined in such section 502(x)) labeled on or after the date that is 1 year after the date of enact- ment of this Act [Dec. 22, 2006].’’ EFFECTIVE DATE OF 2002 AMENDMENT Pub. L. 107–250, title III, § 301(b), Oct. 26, 2002, 116 Stat. 1616, as amended by Pub. L. 108–214, § 2(c)(1), Apr. 1, 2004, 118 Stat. 575; Pub. L. 109–43, § 2(d), Aug. 1, 2005, 119 Stat. 441, provided that: ‘‘Section 502(u) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 352(u)] (as amended by section 2(c) of the Medical Device User Fee Sta- bilization Act of 2005 [Pub. L. 109–43])— ‘‘(1) shall be effective— ‘‘(A) with respect to devices described under para- graph (1) of such section, 12 months after the date of enactment of the Medical Device User Fee Sta- bilization Act of 2005 [Aug. 1, 2005], or the date on which the original device first bears the name of the manufacturer of the original device, a generally recognized abbreviation of such name, or a unique and generally recognized symbol identifying such manufacturer, whichever is later; and ‘‘(B) with respect to devices described under para- graph (2) of such section 502(u), 12 months after such date of enactment; and ‘‘(2) shall apply only to devices reprocessed and in- troduced or delivered for introduction in interstate commerce after such applicable effective date.’’ Pub. L. 107–250, title III, § 302(a)(2), Oct. 26, 2002, 116 Stat. 1616, provided that: ‘‘The amendment made by paragraph (1) [amending this section] takes effect 15 months after the date of the enactment of this Act [Oct. 26, 2002], and only applies to devices introduced or delivered for introduction into interstate commerce after such effective date.’’ EFFECTIVE DATE OF 1997 AMENDMENT Amendment by sections 114(a), 126(b), and 412(c) of Pub. L. 105–115 effective 90 days after Nov. 21, 1997, ex- cept as otherwise provided, see section 501 of Pub. L. 105–115, set out as a note under section 321 of this title. EFFECTIVE DATE OF 1978 AMENDMENT Amendment by Pub. L. 95–633 effective on date the Convention on Psychotropic Substances enters into force in the United States [July 15, 1980], see section 112 of Pub. L. 95–633, set out as an Effective Date note under section 801a of this title. EFFECTIVE DATE OF 1970 AMENDMENT Amendment by Pub. L. 91–601 effective Dec. 30, 1970, and regulations establishing special packaging stand- ards 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 1968 AMENDMENT Amendment by Pub. L. 90–399 effective on first day of thirteenth calendar month after July 13, 1968, see sec- tion 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 1962 AMENDMENT Pub. L. 87–781, title I, § 112(c), Oct. 10, 1962, 76 Stat. 791, provided that: ‘‘This section [amending this sec- tion] shall take effect on the first day of the seventh calendar month following the month in which this Act is enacted [October 1962].’’ Page 166 TITLE 21—FOOD AND DRUGS § 352 Pub. L. 87–781, title I, § 131(b), Oct. 10, 1962, 76 Stat. 792, provided that: ‘‘No drug which was being commer- cially distributed prior to the date of enactment of this Act [Oct. 10, 1962] shall be deemed to be misbranded under paragraph (n) of section 502 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 352(n)], as added by this section, until the earlier of the following dates: (1) the first day of the seventh month following the month in which this Act is enacted; or (2) the effective date of regulations first issued under clause (3) of such para- graph (n) in accordance with the procedure specified in section 701(e) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 371(e)].’’ Amendment by Pub. L. 87–781 effective on first day of seventh calendar month following October 1962, see sec- tion 107 of Pub. L. 87–781, set out as a note under sec- tion 321 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; POSTPONEMENT Pars. (b) and (d) to (h) effective Jan. 1, 1940, and such paragraphs effective July 1, 1940, as provided by regula- tions for certain lithographed labeling and containers bearing certain labeling, 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. REGULATIONS Pub. L. 110–85, title IX, § 901(d)(3)(B), Sept. 27, 2007, 121 Stat. 940, provided that: ‘‘Not later than 30 months after the date of the enactment of the Food and Drug Administration Amendments Act of 2007 [Sept. 27, 2007], the Secretary of Health and Human Services shall by regulation establish standards for determining whether a major statement relating to side effects and contra- indications of a drug, described in section 502(n) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(n)) (as amended by subparagraph (A)) is presented in the manner required under such section.’’ CONSTRUCTION OF 2016 AMENDMENT Nothing in amendment by section 3044(b)(2) of Pub. L. 114–255 to be construed to restrict the prescribing of antimicrobial drugs or other products, including drugs approved under section 356(h) of this title, by health care professionals, or to limit the practice of health care, see section 3043 of Pub. L. 114–255, set out as a note under section 356 of this title. PRESENTATION OF PRESCRIPTION DRUG BENEFIT AND RISK INFORMATION Pub. L. 111–148, title III, § 3507, Mar. 23, 2010, 124 Stat. 530, provided that: ‘‘(a) IN GENERAL.—The Secretary of Health and Human Services (referred to in this section as the ‘Sec- retary’), acting through the Commissioner of Food and Drugs, shall determine whether the addition of quan- titative summaries of the benefits and risks of pre- scription drugs in a standardized format (such as a table or drug facts box) to the promotional labeling or print advertising of such drugs would improve health care decisionmaking by clinicians and patients and consumers. ‘‘(b) REVIEW AND CONSULTATION.—In making the de- termination under subsection (a), the Secretary shall review all available scientific evidence and research on decisionmaking and social and cognitive psychology and consult with drug manufacturers, clinicians, pa- tients and consumers, experts in health literacy, rep- resentatives of racial and ethnic minorities, and ex- perts in women’s and pediatric health. ‘‘(c) REPORT.—Not later than 1 year after the date of enactment of this Act [Mar. 23, 2010], the Secretary shall submit to Congress a report that provides— ‘‘(1) the determination by the Secretary under sub- section (a); and ‘‘(2) the reasoning and analysis underlying that de- termination. ‘‘(d) AUTHORITY.—If the Secretary determines under subsection (a) that the addition of quantitative sum- maries of the benefits and risks of prescription drugs in a standardized format (such as a table or drug facts box) to the promotional labeling or print advertising of such drugs would improve health care decisionmaking by clinicians and patients and consumers, then the Sec- retary, not later than 3 years after the date of submis- sion of the report under subsection (c), shall promul- gate proposed regulations as necessary to implement such format. ‘‘(e) CLARIFICATION.—Nothing in this section shall be construed to restrict the existing authorities of the Secretary with respect to benefit and risk informa- tion.’’ GUIDANCE; MISBRANDED DEVICES Pub. L. 109–43, § 2(c)(2), Aug. 1, 2005, 119 Stat. 441, pro- vided that: ‘‘Not later than 180 days after the date of enactment of this Act [Aug. 1, 2005], the Secretary of Health and Human Services shall issue guidance to identify circumstances in which the name of the manu- facturer of the original device, a generally recognized abbreviation of such name, or a unique and generally recognized symbol identifying such manufacturer, is not ‘prominent and conspicuous’, as used in section 502(u) of Federal Food, Drug, and Cosmetic Act [21 U.S.C. 352(u)] (as amended by paragraph (1)).’’ STUDIES Pub. L. 110–85, title IX, § 906(b), Sept. 27, 2007, 121 Stat. 950, provided that: ‘‘(1) IN GENERAL.—In the case of direct-to-consumer television advertisements, the Secretary of Health and Human Services, in consultation with the Advisory Committee on Risk Communication under section 567 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360bbb–6] (as added by section 917), shall, not later than 6 months after the date of the enactment of this Act [Sept. 27, 2007], conduct a study to determine if the statement in section 502(n) of such Act [21 U.S.C. 352(n)] (as added by subsection (a)) required with respect to published direct-to-consumer advertisements is appro- priate for inclusion in such television advertisements. ‘‘(2) CONTENT.—As part of the study under paragraph (1), such Secretary shall consider whether the informa- tion in the statement described in paragraph (1) would detract from the presentation of risk information in a direct-to-consumer television advertisement. If such Secretary determines the inclusion of such statement is appropriate in direct-to-consumer television adver- tisements, such Secretary shall issue regulations re- quiring the implementation of such statement in di- rect-to-consumer television advertisements, including determining a reasonable length of time for displaying the statement in such advertisements. The Secretary shall report to the appropriate committees of Congress the findings of such study and any plans to issue regu- lations under this paragraph.’’ Pub. L. 108–173, title I, § 107(f), Dec. 8, 2003, 117 Stat. 2171, directed the Secretary of Health and Human Serv- ices to undertake a study of how to make prescription pharmaceutical information, including drug labels and usage instructions, accessible to blind and visually-im- paired individuals, and to submit a report to Congress not later than 18 months after Dec. 8, 2003. Pub. L. 105–115, title I, § 114(b), Nov. 21, 1997, 111 Stat. 2312, provided that: ‘‘The Comptroller General of the United States shall conduct a study of the implementa- tion of the provisions added by the amendment made by subsection (a) [amending this section]. Not later than 4 years and 6 months after the date of enactment of this Act [Nov. 21, 1997], the Comptroller General of the United States shall prepare and submit to Congress a report containing the findings of the study.’’ Page 167 TITLE 21—FOOD AND DRUGS § 353 COUNTERFEITING OF DRUGS; CONGRESSIONAL FINDINGS AND DECLARATION OF POLICY Pub. L. 89–74, § 9(a), July 15, 1965, 79 Stat. 234, provided that: ‘‘The Congress finds and declares that there is a substantial traffic in counterfeit drugs simulating the brand or other identifying mark or device of the manu- facturer of the genuine article; that such traffic poses a serious hazard to the health of innocent consumers of such drugs because of the lack of proper qualifications, facilities, and manufacturing controls on the part of the counterfeiter, whose operations are clandestine; that, while such drugs are deemed misbranded within the meaning of section 502(i) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 352(i)], the controls for the suppression of the traffic in such drugs are inadequate because of the difficulty of determining the place of interstate origin of such drugs and, if that place is dis- covered, the fact that the implements for counter- feiting are not subject to seizure, and that these factors require enactment of additional controls with respect to such drugs without regard to their interstate or intrastate origins.’’ Provisions as effective Feb. 1, 1966, see section 11 of Pub. L. 89–74, set out as an Effective Date of 1965 Amendment note under section 321 of this title. Executive Documents TRANSFER OF FUNCTIONS For transfer of functions of Federal Security Admin- istrator 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. § 353. Exemptions and consideration for certain drugs, devices, and biological products (a) Regulations for goods to be processed, la- beled, or repacked elsewhere The Secretary is directed to promulgate regu- lations exempting from any labeling or pack- aging requirement of this chapter drugs and de- vices which are, in accordance with the practice of the trade, to be processed, labeled, or re- packed in substantial quantities at establish- ments other than those where originally proc- essed or packed, on condition that such drugs and devices are not adulterated or misbranded under the provisions of this chapter upon re- moval from such processing, labeling, or repack- ing establishment. (b) Prescription by physician; exemption from la- beling and prescription requirements; mis- branded drugs; compliance with narcotic and marihuana laws (1) A drug intended for use by man which— (A) because of its toxicity or other poten- tiality 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 su- pervision 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 li- censed by law to administer such drug; shall be dispensed only (i) upon a written pre- scription of a practitioner licensed by law to ad- minister such drug, or (ii) upon an oral prescrip- tion of such practitioner which is reduced promptly to writing and filed by the pharmacist, or (iii) by refilling any such written or oral pre- scription if such refilling is authorized by the prescriber either in the original prescription or by oral order which is reduced promptly to writ- ing and filed by the pharmacist. The act of dis- pensing a drug contrary to the provisions of this paragraph shall be deemed to be an act which re- sults 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 li- censed 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 pre- scription or of its filling, the name of the pre- scriber, 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 pursu- ant 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 con- strued to relieve any person from any require- ment prescribed by or under authority of law with respect to drugs now included or which may hereafter be included within the classifica- tions 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 in- tended 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 manu- facturer or distributor to criminal liability sole- ly because of a sale, purchase, trade, or offer to sell, purchase, or trade in violation of this para- graph 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 re- deemed, at no cost or at a reduced cost, for a drug which is prescribed in accordance with sub- section (b). (3)(A) No person may sell, purchase, or trade, or offer to sell, purchase, or trade, any drug—