Source: http://www.law.cornell.edu/uscode/text/21/353?quicktabs_8=4
Timestamp: 2015-01-31 10:37:36
Document Index: 362062743

Matched Legal Cases: ['§ 353', '§ 353', '§ 353', '§ 503', '§ 1', '§ 104', '§ 6', '§ 7', '§ 1205', '§ 4', '§ 105', '§ 16', '§ 2', '§ 6', '§ 2', '§ 5', '§ 123', '§ 204', '§ 102', '§ 204', '§ 204', '§ 125', '§ 204', '§ 204', '§ 102', '§ 102', '§ 204', '§ 204', '§ 204', '§ 204', '§ 126', '§ 126', '§ 126', '§ 123', '§ 123', '§ 4', '§ 4', '§ 4', '§ 4', '§ 2', '§ 2', '§ 4', '§ 2', '§ 2', '§ 2', '§ 2', '§ 2', '§ 2', '§ 2', '§ 2', '§ 16', '§ 16', '§ 4', '§ 5', '§ 6', '§ 204', '§ 2', '§ 8', '§ 601', '§ 2', 'art 3', 'art 4', 'art 5', 'art 7', 'art 10', 'art 11', 'art 12', 'art 13', 'art 14', 'art 15', 'art 16', 'art 20', 'art 25', 'art 50', 'art 54', 'art 56', 'art 58', 'art 200', 'art 201', 'art 203', 'art 205', 'art 208', 'art 209', 'art 250', 'art 290', 'art 310', 'art 312', 'art 314', 'art 315', 'art 328', 'art 330', 'art 331', 'art 332', 'art 333', 'art 335', 'art 336', 'art 338', 'art 340', 'art 341', 'art 343', 'art 344', 'art 346', 'art 347', 'art 348', 'art 349', 'art 350', 'art 352', 'art 355', 'art 357', 'art 358', 'art 361', 'art 369', 'art 500', 'art 511', 'art 514', 'art 530', 'art 571', 'art 600', 'art 601', 'art 610', 'art 61621', 'art 640', 'art 660', 'art 680', 'art 812', 'art 814', 'art 830']

21 U.S. Code § 353 - Exemptions and consideration for certain drugs, devices, and biological products | LII / Legal Information Institute
U.S. Code › Title 21 › Chapter 9 › Subchapter V › Part A › § 353 21 U.S. Code § 353 - Exemptions and consideration for certain drugs, devices, and biological products
Regulations for goods to be processed, labeled, or repacked elsewhere The Secretary is directed to promulgate regulations exempting from any labeling or packaging requirement of this chapter drugs and devices which are, in accordance with the practice of the trade, to be processed, labeled, or repacked in substantial quantities at establishments other than those where originally processed or packed, on condition that such drugs and devices are not adulterated or misbranded under the provisions of this chapter upon removal from such processing, labeling, or repacking establishment.
Prescription by physician; exemption from labeling and prescription requirements; misbranded drugs; compliance with narcotic and marihuana laws (1)
shall be dispensed only (i)
upon a written prescription of a practitioner licensed by law to administer such drug, or (ii)
upon an oral prescription of such practitioner which is reduced promptly to writing and filed by the pharmacist, or (iii)
by refilling any such written or oral prescription if such refilling is authorized by the prescriber either in the original prescription or by oral order which is reduced promptly to writing and filed by the pharmacist. The act of dispensing a drug contrary to the provisions of this paragraph shall be deemed to be an act which results in the drug being misbranded while held for sale.
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) of this section, the term “drug sample” means a unit of a drug, subject to subsection (b) of this section, which is not intended to be sold and is intended to promote the sale of the drug. Nothing in this paragraph shall subject an officer or executive of a drug manufacturer or distributor to criminal liability solely because of a sale, purchase, trade, or offer to sell, purchase, or trade in violation of this paragraph by other employees of the manufacturer or distributor.
No person may sell, purchase, or trade, offer to sell, purchase, or trade, or counterfeit any coupon. For purposes of this paragraph, the term “coupon” means a form which may be redeemed, at no cost or at a reduced cost, for a drug which is prescribed in accordance with subsection (b) of this section.
which is subject to subsection (b) of this section, and
which was donated or supplied at a reduced price to a charitable organization described in section 501
(c)(3) of title 26.
a sale, purchase, or trade of a drug, an offer to sell, purchase, or trade a drug, or the dispensing of a drug pursuant to a prescription executed in accordance with subsection (b) of this section.
Distribution of drug samples (1)
The manufacturer or authorized distributor of record of a drug subject to subsection (b) of this section may, in accordance with this paragraph, distribute drug samples by mail or common carrier to practitioners licensed to prescribe such drugs or, at the request of a licensed practitioner, to pharmacies of hospitals or other health care entities. Such a distribution of drug samples may only be made—
The manufacturer or authorized distributor of record of a drug subject to subsection (b) of this section may, by means other than mail or common carrier, distribute drug samples only if the manufacturer or authorized distributor of record makes the distributions in accordance with subparagraph (A) and carries out the activities described in subparagraphs (B) through (F) as follows:
Drug manufacturers or authorized distributors of record shall report to the Secretary any conviction of their representatives for violations of subsection (c)(1) of this section or a State law because of the sale, purchase, or trade of a drug sample or the offer to sell, purchase, or trade a drug sample.
Wholesale distributors; guidelines for licensing; definitions (1)
Each person who is engaged in the wholesale distribution of a drug subject to subsection (b) of this section and who is not the manufacturer or an authorized distributor of record of such drug shall, before each wholesale distribution of such drug (including each distribution to an authorized distributor of record or to a retail pharmacy), provide to the person who receives the drug a statement (in such form and containing such information as the Secretary may require) identifying each prior sale, purchase, or trade of such drug (including the date of the transaction and the names and addresses of all parties to the transaction).
Each manufacturer of a drug subject to subsection (b) of this section shall maintain at its corporate offices a current list of the authorized distributors of record of such drug.
No person may engage in the wholesale distribution in interstate commerce of drugs subject to subsection (b) of this section in a State unless such person is licensed by the State in accordance with the guidelines issued under subparagraph (B).
The Secretary shall by regulation issue guidelines establishing minimum standards, terms, and conditions for the licensing of persons to make wholesale distributions in interstate commerce of drugs subject to subsection (b) of this section. Such guidelines shall prescribe requirements for the storage and handling of such drugs and for the establishment and maintenance of records of the distributions of such drugs.
For the purposes of this subsection and subsection (d) of this section—
the term “authorized distributors of record” means those distributors with whom a manufacturer has established an ongoing relationship to distribute such manufacturer’s products, and
the term “wholesale distribution” means distribution of drugs subject to subsection (b) of this section to other than the consumer or patient but does not include intracompany sales and does not include distributions of drugs described in subsection (c)(3)(B) of this section.
Veterinary prescription drugs (1)
is limited by an approved application under subsection (b) ofsection 360b of this title, a conditionally-approved application under section 360ccc of this title, or an index listing under section 360ccc–1 of this title to use under the professional supervision of a licensed veterinarian,
Regulation of combination products (1)
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 drug (other than a biological product), the agency center charged with premarket review of drugs shall have primary jurisdiction,
a device, the agency center charged with premarket review of devices shall have primary jurisdiction, or
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.
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.
In order to ensure the timeliness of the premarket review of a combination product, the agency center with primary jurisdiction for the product, and the consulting agency center, shall be responsible to the Office with respect to the timeliness of the premarket review.
The Secretary, acting through the Office, shall review each agreement, guidance, or practice of the Secretary that is specific to the assignment of combination products to agency centers and shall determine whether the agreement, guidance, or practice is consistent with the requirements of this subsection. In carrying out such review, the Secretary shall consult with stakeholders and the directors of the agency centers. After such consultation, the Secretary shall determine whether to continue in effect, modify, revise, or eliminate such agreement, guidance, or practice, and shall publish in the Federal Register a notice of the availability of such modified or revised agreement, guidance or practice. Nothing in this paragraph shall be construed as preventing the Secretary from following each agreement, guidance, or practice until continued, modified, revised, or eliminated.
Not later than one year after October 26, 2002, and annually thereafter, the Secretary shall report to the appropriate committees of Congress on the activities and impact of the Office. The report shall include provisions—
identifying the number of premarket reviews of such products that involved a consulting agency center; and
describing improvements in the consistency of postmarket regulation of combination products.
The term “biological product” has the meaning given the term in section 262
(i) of title 42.
approval of an application under section 355, 357,
360e, or 360j
(g) of this title,
a finding of substantial equivalence under this part, and
approval of a biologics license application under subsection (a) ofsection 262 of title 42.
(June 25, 1938, ch. 675, § 503,52 Stat. 1051; Oct. 26, 1951, ch. 578, § 1,65 Stat. 648; Pub. L. 87–781, title I, § 104(e)(2),Oct. 10, 1962, 76 Stat. 785; Pub. L. 91–601, § 6(e), formerly § 7(e),Dec. 30, 1970, 84 Stat. 1673, renumbered Pub. L. 97–35, title XII, § 1205(c),Aug. 13, 1981, 95 Stat. 716; Pub. L. 100–293, §§ 4–6,Apr. 22, 1988, 102 Stat. 96–98; Pub. L. 100–670, title I, § 105,Nov. 16, 1988, 102 Stat. 3983; Pub. L. 101–629, § 16(a),Nov. 28, 1990, 104 Stat. 4526; Pub. L. 102–108, § 2(d),Aug. 17, 1991, 105 Stat. 550; Pub. L. 102–300, § 6(d),June 16, 1992, 106 Stat. 240; Pub. L. 102–353, §§ 2(a)–(c), 4, Aug. 26, 1992, 106 Stat. 941, 942; Pub. L. 104–250, § 5(a),Oct. 9, 1996, 110 Stat. 3155; Pub. L. 105–115, title I, §§ 123(e), 126
(a), (c)(1), (2),Nov. 21, 1997, 111 Stat. 2324, 2327, 2328; Pub. L. 107–250, title II, § 204,Oct. 26, 2002, 116 Stat. 1611; Pub. L. 108–282, title I, § 102(b)(5)(F),Aug. 2, 2004, 118 Stat. 903; Pub. L. 113–54, title II, § 204(a)(1)–(4), (b), Nov. 27, 2013, 127 Stat. 630–635.)
Amendment of Subsections (d) and (e)
Pub. L. 113–54, title II, § 204(a)(1)–(4), (b), (c), Nov. 27, 2013, 127 Stat. 630–636, provided that, effective Jan. 1, 2015, this section is amended as follows:
(1) in subsection (d), by adding at the end the following:
(4) In this subsection, the term “authorized distributors of record” means those distributors with whom a manufacturer has established an ongoing relationship to distribute such manufacturer’s products.; and
(2) in subsection (e), by striking paragraphs (1) to (3) and adding the following:
(1) Requirement.—Subject to section 360eee–2 of this title:
(A) In general.—No person may engage in wholesale distribution of a drug subject to subsection (b)(1) in any State unless such person—
(i)(I) is licensed by the State from which the drug is distributed; or
(II) if the State from which the drug is distributed has not established a licensure requirement, is licensed by the Secretary; and
(ii) if the drug is distributed interstate, is licensed by the State into which the drug is distributed if the State into which the drug is distributed requires the licensure of a person that distributes drugs into the State.
(B) Standards.—Each Federal and State license described in subparagraph (A) shall meet the standards, terms, and conditions established by the Secretary under section 360eee–2 of this title.
(2) Reporting and database.—
(A) Reporting.—Beginning January 1, 2015, any person who owns or operates an establishment that engages in wholesale distribution shall—
(i) report to the Secretary, on an annual basis pursuant to a schedule determined by the Secretary—
(I) each State by which the person is licensed and the appropriate identification number of each such license; and
(II) the name, address, and contact information of each facility at which, and all trade names under which, the person conducts business; and
(ii) report to the Secretary within a reasonable period of time and in a reasonable manner, as determined by the Secretary, any significant disciplinary actions, such as the revocation or suspension of a wholesale distributor license, taken by a State or the Federal Government during the reporting period against the wholesale distributor.
(B) Database.—Not later than January 1, 2015, the Secretary shall establish a database of authorized wholesale distributors. Such database shall—
(i) identify each authorized wholesale distributor by name, contact information, and each State where such wholesale distributor is appropriately licensed to engage in wholesale distribution;
(ii) be available to the public on the Internet Web site of the Food and Drug Administration; and
(iii) be regularly updated on a schedule determined by the Secretary.
(C) Coordination.—The Secretary shall establish a format and procedure for appropriate State officials to access the information provided pursuant to subparagraph (A) in a prompt and secure manner.
(D) Confidentiality.—Nothing in this paragraph shall be construed as authorizing the Secretary to disclose any information that is a trade secret or confidential information subject to section 552
(b)(4) of title 5 or section 1905 of title 18.
(3) Costs.—
(A) Authorized fees of secretary.—If a State does not establish a licensing program for persons engaged in the wholesale distribution of a drug subject to subsection (b), the Secretary shall license a person engaged in wholesale distribution located in such State and may collect a reasonable fee in such amount necessary to reimburse the Secretary for costs associated with establishing and administering the licensure program and conducting periodic inspections under this section. The Secretary shall adjust fee rates as needed on an annual basis to generate only the amount of revenue needed to perform this service. Fees authorized under this paragraph shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts. Such fees are authorized to remain available until expended. Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation.
(B) State licensing fees.—Nothing in this chapter shall prohibit States from collecting fees from wholesale distributors in connection with State licensing of such distributors.
(4) For the purposes of this subsection and subsection (d), the term “wholesale distribution” means the distribution of a drug subject to subsection (b) to a person other than a consumer or patient, or receipt of a drug subject to subsection (b) by a person other than the consumer or patient, but does not include—
(A) intracompany distribution of any drug between members of an affiliate or within a manufacturer;
(B) the distribution of a drug, or an offer to distribute a drug among hospitals or other health care entities which are under common control;
(C) the distribution of a drug or an offer to distribute a drug for emergency medical reasons, including a public health emergency declaration pursuant to section 247d of title 42, except that, for purposes of this paragraph, a drug shortage not caused by a public health emergency shall not constitute an emergency medical reason;
(D) the dispensing of a drug pursuant to a prescription executed in accordance with subsection (b)(1);
(E) the distribution of minimal quantities of drug by a licensed retail pharmacy to a licensed practitioner for office use;
(F) the distribution of a drug or an offer to distribute a drug by a charitable organization to a nonprofit affiliate of the organization to the extent otherwise permitted by law;
(G) the purchase or other acquisition by a dispenser, hospital, or other health care entity of a drug for use by such dispenser, hospital, or other health care entity;
(H) the distribution of a drug by the manufacturer of such drug;
(I) the receipt or transfer of a drug by an authorized third-party logistics provider provided that such third-party logistics provider does not take ownership of the drug;
(J) a common carrier that transports a drug, provided that the common carrier does not take ownership of the drug;
(K) the distribution of a drug, or an offer to distribute a drug by an authorized repackager that has taken ownership or possession of the drug and repacks it in accordance with section 360eee–1(e) of this title;
(L) salable drug returns when conducted by a dispenser;
(M) the distribution of a collection of finished medical devices, which may include a product or biological product, assembled in kit form strictly for the convenience of the purchaser or user (referred to in this subparagraph as a “medical convenience kit”) if—
(i) the medical convenience kit is assembled in an establishment that is registered with the Food and Drug Administration as a device manufacturer in accordance with section 360
(b)(2) of this title;
(ii) the medical convenience kit does not contain a controlled substance that appears in a schedule contained in the Comprehensive Drug Abuse Prevention and Control Act of 1970;
(iii) in the case of a medical convenience kit that includes a product, the person that manufacturers the kit—
(I) purchased such product directly from the pharmaceutical manufacturer or from a wholesale distributor that purchased the product directly from the pharmaceutical manufacturer; and
(II) does not alter the primary container or label of the product as purchased from the manufacturer or wholesale distributor; and
(iv) in the case of a medical convenience kit that includes a product, the product is—
(I) an intravenous solution intended for the replenishment of fluids and electrolytes;
(II) a product intended to maintain the equilibrium of water and minerals in the body;
(III) a product intended for irrigation or reconstitution;
(IV) an anesthetic;
(V) an anticoagulant;
(VI) a vasopressor; or
(VII) a sympathomimetic;
(N) the distribution of an intravenous drug that, by its formulation, is intended for the replenishment of fluids and electrolytes (such as sodium, chloride, and potassium) or calories (such as dextrose and amino acids);
(O) the distribution of an intravenous drug used to maintain the equilibrium of water and minerals in the body, such as dialysis solutions;
(P) the distribution of a drug that is intended for irrigation, or sterile water, whether intended for such purposes or for injection;
(Q) the distribution of medical gas, as defined in section 360ddd of this title;
(R) facilitating the distribution of a product by providing solely administrative services, including processing of orders and payments; or
(S) the transfer of a product by a hospital or other health care entity, or by a wholesale distributor or manufacturer operating at the direction of the hospital or other health care entity, to a repackager described in section 360eee(16)(B) of this title and registered under section 360 of this title for the purpose of repackaging the drug for use by that hospital, or other health care entity and other health care entities that are under common control, if ownership of the drug remains with the hospital or other health care entity at all times.
(5) Third-party logistics providers.—Notwithstanding paragraphs (1) through (4), each entity that meets the definition of a third-party logistics provider under section 360eee(22) of this title shall obtain a license as a third-party logistics provider as described in section 360eee–3(a) of this title and is not required to obtain a license as a wholesale distributor if the entity never assumes an ownership interest in the product it handles.
(6) Affiliate.—For purposes of this subsection, the term “affiliate” means a business entity that has a relationship with a second business entity if, directly or indirectly—
(A) one business entity controls, or has the power to control, the other business entity; or
(B) a third party controls, or has the power to control, both of the business entities.
See 2013 Amendment notes below.
Section 357 of this title, referred to in subsec. (g)(5)(C)(i), was repealed by Pub. L. 105–115, title I, § 125(b)(1),Nov. 21, 1997, 111 Stat. 2325.
In subsec. (b)(5), “sections 4721, 6001, and 6151 of title 26” and “section 4761 of title 26” substituted for “section 3220 of the Internal Revenue Code (26 U.S.C. 3220)” and “section 3238(b) of the Internal Revenue Code (26 U.S.C. 3238(b))”, respectively, on authority of section 7852
(b) of Title 26, Internal Revenue Code.
2013—Subsec. (d)(4). Pub. L. 113–54, § 204(b), added par. (4).
Subsec. (e). Pub. L. 113–54, § 204(a)(1)–(4), added pars. (1) to (6) and struck out former pars. (1) to (3). Prior to amendment, pars. (1) to (3) set out certain disclosure and licensing requirements for wholesale distributors and defined “authorized distributors of record” and “wholesale distribution”.
2004—Subsec. (f)(1)(A)(ii). Pub. L. 108–282, § 102(b)(5)(F)(i), substituted “360b of this title, a conditionally-approved application under section 360ccc of this title, or an index listing under section 360ccc–1 of this title” for “360b of this title”.
Subsec. (f)(3). Pub. L. 108–282, § 102(b)(5)(F)(ii), substituted “section 360b, 360ccc, or 360ccc–1” for “section 360b”.
2002—Subsec. (g)(1). Pub. L. 107–250, § 204(1)(A), substituted “shall in accordance with this subsection assign an agency center” for “shall designate a component of the Food and Drug Administration” in first sentence of introductory provisions.
Subsec. (g)(1)(A) to (C). Pub. L. 107–250, § 204(1)(B), substituted “the agency center charged” for “the persons charged”.
Subsec. (g)(4). Pub. L. 107–250, § 204(3), added par. (4). Former par. (4) redesignated (5).
Subsec. (g)(5). Pub. L. 107–250, § 204(2), (4), redesignated par. (4) as (5), added subpar. (A), and redesignated former subpars. (A) and (B) as (B) and (C), respectively.
1997—Subsec. (b)(1)(A) to (C). Pub. L. 105–115, § 126(c)(1), redesignated subpars. (B) and (C) as (A) and (B), respectively, and struck out former subpar. (A), which read as follows: “is a habit-forming drug to which section 352
(d) of this title applies; or”.
Subsec. (b)(3). Pub. L. 105–115, § 126(c)(2), struck out reference to section 352
(d) of this title before “355”.
Subsec. (b)(4). Pub. L. 105–115, § 126(a), amended par. (4) generally. Prior to amendment, par. (4) read as follows: “A drug which is subject to paragraph (1) of this subsection shall be deemed to be misbranded if at any time prior to dispensing its label fails to bear the statement ‘Caution: Federal law prohibits dispensing without prescription’. A drug to which paragraph (1) of this subsection does not apply shall be deemed to be misbranded if at any time prior to dispensing its label bears the caution statement quoted in the preceding sentence.”
Subsec. (g)(4)(A). Pub. L. 105–115, § 123(e)(1), substituted “section 262
(i) of title 42” for “section 262
(a) of title 42”.
Subsec. (g)(4)(B)(iii). Pub. L. 105–115, § 123(e)(2), substituted “biologics license application under subsection (a)” for “product or establishment license under subsection (a) or (d)”.
1996—Subsec. (f)(1)(A). Pub. L. 104–250inserted “, other than a veterinary feed directive drug intended for use in animal feed or an animal feed bearing or containing a veterinary feed directive drug,” after “other than man” in introductory provisions.
1992—Subsec. (d)(1). Pub. L. 102–353, § 4(1), amended par. (1) generally. Prior to amendment, par. (1) read as follows: “Except as provided in paragraphs (2) and (3), no representative of a drug manufacturer or distributor may distribute any drug sample.”
Subsec. (d)(2). Pub. L. 102–353, § 4(2), substituted “authorized distributor of record” for “distributor” wherever appearing.
Subsec. (d)(3). Pub. L. 102–353, § 4(2), substituted “authorized distributor of record” for “distributor” and “authorized distributors of record” for “distributors” wherever appearing.
Subsec. (e)(1). Pub. L. 102–353, § 4(3), amended par. (1) generally. Prior to amendment, par. (1) read as follows: “Each person who is engaged in the wholesale distribution of drugs subject to subsection (b) of this section and who is not an authorized distributor of record of such drugs shall provide to each wholesale distributor of such drugs a statement identifying each sale of the drug (including the date of the sale) before the sale to such wholesale distributor. Each manufacturer shall maintain at its corporate offices a current list of such authorized distributors.”
Subsec. (e)(2)(A). Pub. L. 102–353, § 2(a), (d), temporarily inserted “or has registered with the Secretary in accordance with paragraph (3)”. See Termination Date of 1992 Amendment note below.
Subsec. (e)(3). Pub. L. 102–353, § 2(b), (d), temporarily added par. (3). Former par. (3) redesignated (4). See Termination Date of 1992 Amendment note below.
Subsec. (e)(4). Pub. L. 102–353, § 4(4), inserted “and subsection (d) of this section” after “For the purposes of this subsection”.
Pub. L. 102–353, § 2(b), (d), temporarily redesignated par. (3) as (4). See Termination Date of 1992 Amendment note below.
Subsec. (f)(1)(B). Pub. L. 102–353, § 2(c), which directed the substitution of “an order” for “and order”, could not be executed because “and order” did not appear in subpar. (B).
Subsec. (g)(3). Pub. L. 102–300substituted “clearance” for “approval”.
1991—Subsec. (c). Pub. L. 102–108, § 2(d)(3), redesignatedsubsec. (c), relating to veterinary prescription drugs, as (f). Former subsec. (f) redesignated (g).
Subsec. (c)(2), (3)(B)(v). Pub. L. 102–108, § 2(d)(1), made technical amendment to reference to subsection (b) of this section involving corresponding provision of original act.
Subsec. (d)(3)(E). Pub. L. 102–108, § 2(d)(2), made technical amendment to reference to subsection (c)(1) of this section involving corresponding provision of original act.
Subsec. (f). Pub. L. 102–108, § 2(d)(4), redesignatedsubsec. (f), relating to regulation of combination products, as (g).
Pub. L. 102–108, § 2(d)(3), redesignatedsubsec. (c), relating to veterinary prescription drugs, as (f).
Subsec. (g). Pub. L. 102–108, § 2(d)(4), redesignatedsubsec. (f), relating to regulation of combination products, as (g).
1990—Pub. L. 101–629, § 16(a)(1), substituted “Exemptions and consideration for certain drugs, devices, and biological products” for “Exemptions in case of drugs and devices” in section catchline.
Subsec. (f). Pub. L. 101–629, § 16(a)(2), added subsec. (f).
1988—Subsec. (c). Pub. L. 100–670added subsec. (c) relating to veterinary prescription drugs.
Pub. L. 100–293, § 4, added subsec. (c) relating to sales restrictions.
Subsec. (d). Pub. L. 100–293, § 5, added subsec. (d).
Subsec. (e). Pub. L. 100–293, § 6, added subsec. (e).
1970—Subsec. (b)(2). Pub. L. 91–601included exemption from packaging requirements of subsec. (p) ofsection 352 of this title.
1962—Subsec. (b)(1)(C). Pub. L. 87–781substituted “approved” for “effective”.
1951—Subsec. (b). Act Oct. 26, 1951, amended subsec. (b) generally to protect the public from abuses in the sale of potent prescription drugs, and to relieve retail pharmacists and the public from unnecessary restrictions on the dispensation of drugs that are safe to use without supervision of a doctor.
Pub. L. 113–54, title II, § 204(c),Nov. 27, 2013, 127 Stat. 636, provided that: “The amendments made by subsections (a) and (b) [enacting section 360eee–2 of this title and amending this section] shall take effect on January 1, 2015.”
Amendment by Pub. L. 105–115effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 ofPub. L. 105–115, set out as a note under section 321 of this title.
Termination Date of 1992 Amendment
Pub. L. 102–353, § 2(d),Aug. 26, 1992, 106 Stat. 941, provided that: “Effective September 14, 1994, the amendments made by subsections (a) and (b) [amending this section] shall no longer be in effect.”
Pub. L. 100–293, § 8,Apr. 22, 1988, 102 Stat. 100, provided that:
“(a) General Rule.—Except as provided in subsection (b), this Act and the amendments made by this Act [amending this section and sections 331, 333, and 381 of this title and enacting provisions set out as notes under this section and section 301 of this title] shall take effect upon the expiration of 90 days after the date of the enactment of this Act [Apr. 22, 1988].
“(b) Exception.—
“(1) Section 503(d) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 353
(d)] (as added by section 5 of this Act) shall take effect upon the expiration of 180 days after the date of the enactment of this Act [Apr. 22, 1988].
“(2) The Secretary of Health and Human Services shall by regulation issue the guidelines required by section 503(e)(2)(B) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 353
(e)(2)(B)] (as added by section 6 of this Act) not later than 180 days after the date of the enactment of this Act. Section 503(e)(2)(A) of such Act shall take effect upon the expiration of 2 years after the date such regulations are promulgated and take effect.”
Amendment by Pub. L. 91–601effective 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 ofPub. L. 91–601, set out as an Effective Date note under section 1471 of Title 15, Commerce and Trade.
Amendment by Pub. L. 87–781effective Oct. 10, 1962, see section 107 ofPub. L. 87–781, set out as a note under section 321 of this title.
Effective Date of 1951 Amendment
Amendment by act Oct. 26, 1951, effective six months after Oct. 26, 1951, see section 3 of act Oct. 26, 1951, set out as a note under section 333 of this title.
Effective Medication Guides
Pub. L. 104–180, title VI, § 601,Aug. 6, 1996, 110 Stat. 1593, provided that:
“(a) In General.—Not later than 30 days after the date of enactment of this Act [Aug. 6, 1996], the Secretary of the Department of Health and Human Services shall request that national organizations representing health care professionals, consumer organizations, voluntary health agencies, the pharmaceutical industry, drug wholesalers, patient drug information database companies, and other relevant parties collaborate to develop a long-range comprehensive action plan to achieve goals consistent with the goals of the proposed rule of the Food and Drug Administration on ‘Prescription Drug Product Labeling: Medication Guide Requirements’ (60 Fed. Reg. 44182; relating to the provision of oral and written prescription information to consumers).
“(b) Goals.—Goals consistent with the proposed rule described in subsection (a) are the distribution of useful written information to 75 percent of individuals receiving new precriptions [sic] by the year 2000 and to 95 percent by the year 2006.
“(c) Plan.—The plan described in subsection (a) shall—
“(1) identify the plan goals;
“(2) assess the effectiveness of the current private-sector approaches used to provide oral and written prescription information to consumers;
“(3) develop guidelines for providing effective oral and written prescription information consistent with the findings of any such assessment;
“(4) contain elements necessary to ensure the transmittal of useful information to the consuming public, including being scientifically accurate, non-promotional in tone and content, sufficiently specific and comprehensive as to adequately inform consumers about the use of the product, and in an understandable, legible format that is readily comprehensible and not confusing to consumers expected to use the product.[;]
“(5) develop a mechanism to assess periodically the quality of the oral and written prescription information and the frequency with which the information is provided to consumers; and
“(6) provide for compliance with relevant State board regulations.
“(d) Limitation on the Authority of the Secretary.—The Secretary of the Department of Health and Human Services shall have no authority to implement the proposed rule described in subsection (a), or to develop any similar regulation, policy statement, or other guideline specifying a uniform content or format for written information voluntarily provided to consumers about prescription drugs if, (1) not later than 120 days after the date of enactment of this Act [Aug. 6, 1996], the national organizations described in subsection (a) develop and submit to the Secretary for Health and Human Services a comprehensive, long-range action plan (as described in subsection (a)) which shall be acceptable to the Secretary of Health and Human Services; (2) the aforementioned plan is submitted to the Secretary of Health and Human Services for review and acceptance: Provided, That the Secretary shall give due consideration to the submitted plan and that any such acceptance shall not be arbitrarily withheld; and (3) the implementation of (a) a plan accepted by the Secretary commences within 30 days of the Secretary’s acceptance of such plan, or (b) the plan submitted to the Secretary commences within 60 days of the submission of such plan if the Secretary fails to take any action on the plan within 30 days of the submission of the plan. The Secretary shall accept, reject or suggest modifications to the plan submitted within 30 days of its submission. The Secretary may confer with and assist private parties in the development of the plan described in subsections (a) and (b).
“(e) Secretary Review.—Not later than January 1, 2001, the Secretary of the Department of Health and Human Services shall review the status of private-sector initiatives designed to achieve the goals of the plan described in subsection (a), and if such goals are not achieved, the limitation in subsection (d) shall not apply, and the Secretary shall seek public comment on other initiatives that may be carried out to meet such goals.”
Pub. L. 100–293, § 2,Apr. 22, 1988, 102 Stat. 95, provided that: “The Congress finds the following:
“(1) American consumers cannot purchase prescription drugs with the certainty that the products are safe and effective.
“(2) The integrity of the distribution system for prescription drugs is insufficient to prevent the introduction and eventual retail sale of substandard, ineffective, or even counterfeit drugs.
“(3) The existence and operation of a wholesale submarket, commonly known as the ‘diversion market’, prevents effective control over or even routine knowledge of the true sources of prescription drugs in a significant number of cases.
“(4) Large amounts of drugs are being reimported to the United States as American goods returned. These imports are a health and safety risk to American consumers because they may have become subpotent or adulterated during foreign handling and shipping.
“(5) The ready market for prescription drug reimports has been the catalyst for a continuing series of frauds against American manufacturers and has provided the cover for the importation of foreign counterfeit drugs.
“(6) The existing system of providing drug samples to physicians through manufacturer’s representatives has been abused for decades and has resulted in the sale to consumers of misbranded, expired, and adulterated pharmaceuticals.
“(7) The bulk resale of below wholesale priced prescription drugs by health care entities, for ultimate sale at retail, helps fuel the diversion market and is an unfair form of competition to wholesalers and retailers that must pay otherwise prevailing market prices.
“(8) The effect of these several practices and conditions is to create an unacceptable risk that counterfeit, adulterated, misbranded, subpotent, or expired drugs will be sold to American consumers.”
This is a list of parts within the Code of Federal Regulations for which this US Code section provides rulemaking authority.This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.21 CFR - Food and Drugs21 CFR Part 3 - PRODUCT JURISDICTION21 CFR Part 4 - REGULATION OF COMBINATION PRODUCTS21 CFR Part 5 - ORGANIZATION21 CFR Part 7 - ENFORCEMENT POLICY21 CFR Part 10 - ADMINISTRATIVE PRACTICES AND PROCEDURES21 CFR Part 11 - ELECTRONIC RECORDS; ELECTRONIC SIGNATURES21 CFR Part 12 - FORMAL EVIDENTIARY PUBLIC HEARING21 CFR Part 13 - PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY21 CFR Part 14 - PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE21 CFR Part 15 - PUBLIC HEARING BEFORE THE COMMISSIONER21 CFR Part 16 - REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION21 CFR Part 20 - PUBLIC INFORMATION21 CFR Part 25 - ENVIRONMENTAL IMPACT CONSIDERATIONS21 CFR Part 50 - PROTECTION OF HUMAN SUBJECTS21 CFR Part 54 - FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS21 CFR Part 56 - INSTITUTIONAL REVIEW BOARDS21 CFR Part 58 - GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES21 CFR Part 200 - GENERAL21 CFR Part 201 - LABELING21 CFR Part 203 - PRESCRIPTION DRUG MARKETING21 CFR Part 205 - GUIDELINES FOR STATE LICENSING OF WHOLESALE PRESCRIPTION DRUG DISTRIBUTORS21 CFR Part 208 - MEDICATION GUIDES FOR PRESCRIPTION DRUG PRODUCTS21 CFR Part 209 - REQUIREMENT FOR AUTHORIZED DISPENSERS AND PHARMACIES TO DISTRIBUTE A SIDE EFFECTS STATEMENT21 CFR Part 250 - SPECIAL REQUIREMENTS FOR SPECIFIC HUMAN DRUGS21 CFR Part 290 - CONTROLLED DRUGS21 CFR Part 310 - NEW DRUGS21 CFR Part 312 - INVESTIGATIONAL NEW DRUG APPLICATION21 CFR Part 314 - APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG21 CFR Part 315 - DIAGNOSTIC RADIOPHARMACEUTICALS21 CFR Part 328 - OVER-THE-COUNTER DRUG PRODUCTS INTENDED FOR ORAL INGESTION THAT CONTAIN ALCOHOL21 CFR Part 330 - OVER-THE-COUNTER (OTC) HUMAN DRUGS WHICH ARE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED21 CFR Part 331 - ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE21 CFR Part 332 - ANTIFLATULENT PRODUCTS FOR OVER-THE-COUNTER HUMAN USE21 CFR Part 333 - TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE21 CFR Part 335 - ANTIDIARRHEAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE21 CFR Part 336 - ANTIEMETIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE21 CFR Part 338 - NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE21 CFR Part 340 - STIMULANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE21 CFR Part 341 - COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE21 CFR Part 343 - INTERNAL ANALGESIC, ANTIPYRETIC, AND ANTIRHEUMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE21 CFR Part 344 57021 CFR Part 346 - ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE21 CFR Part 347 - SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE21 CFR Part 348 - EXTERNAL ANALGESIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE21 CFR Part 349 - OPHTHALMIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE21 CFR Part 350 - ANTIPERSPIRANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE21 CFR Part 352 - SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED INDEFINITELY]21 CFR Part 355 - ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE21 CFR Part 357 - MISCELLANEOUS INTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE21 CFR Part 358 - MISCELLANEOUS EXTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE21 CFR Part 361 - PRESCRIPTION DRUGS FOR HUMAN USE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED: DRUGS USED IN RESEARCH21 CFR Part 369 - INTERPRETATIVE STATEMENTS RE WARNINGS ON DRUGS AND DEVICES FOR OVER-THE-COUNTER SALE21 CFR Part 500 - GENERAL21 CFR Part 511 - NEW ANIMAL DRUGS FOR INVESTIGATIONAL USE21 CFR Part 514 - NEW ANIMAL DRUG APPLICATIONS21 CFR Part 530 - EXTRALABEL DRUG USE IN ANIMALS21 CFR Part 571 - FOOD ADDITIVE PETITIONS21 CFR Part 600 - BIOLOGICAL PRODUCTS: GENERAL21 CFR Part 601 - LICENSING21 CFR Part 610 - GENERAL BIOLOGICAL PRODUCTS STANDARDS21 CFR Part 61621 CFR Part 640 - ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS21 CFR Part 660 - ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS21 CFR Part 680 - ADDITIONAL STANDARDS FOR MISCELLANEOUS PRODUCTS21 CFR Part 812 - INVESTIGATIONAL DEVICE EXEMPTIONS21 CFR Part 814 - PREMARKET APPROVAL OF MEDICAL DEVICES21 CFR Part 830 - UNIQUE DEVICE IDENTIFICATION
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