Exemptions and consideration for certain drugs, devices, and biological products
No person may sell, purchase, or trade or offer to sell, purchase, or trade any drug sample. For purposes of this paragraph and subsection (d), the term “drug sample” means a unit of a drug, subject to subsection (b), which is not intended to be sold and is intended to promote the sale of the drug. Nothing in this paragraph shall subject an officer or executive of a drug manufacturer or distributor to criminal liability solely because of a sale, purchase, trade, or offer to sell, purchase, or trade in violation of this paragraph by other employees of the manufacturer or distributor.
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).
No person may sell, purchase, or trade, or offer to sell, purchase, or trade, any drug—
which is subject to subsection (b), and
which was purchased by a public or private hospital or other health care entity, or
which was donated or supplied at a reduced price to a charitable organization described in section 501(c)(3) of title 26
Subparagraph (A) does not apply to—
the purchase or other acquisition by a hospital or other health care entity which is a member of a group purchasing organization of a drug for its own use from the group purchasing organization or from other hospitals or health care entities which are members of such organization,
the sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug by an organization described in subparagraph (A)(ii)(II) to a nonprofit affiliate of the organization to the extent otherwise permitted by law,
a sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug among hospitals or other health care entities which are under common control,
a sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug for emergency medical reasons, or
a sale, purchase, or trade of a drug, an offer to sell, purchase, or trade a drug, or the dispensing of a drug pursuant to a prescription executed in accordance with subsection (b).
For purposes of this paragraph, the term “entity” does not include a wholesale distributor of drugs or a retail pharmacy licensed under State law and the term “emergency medical reasons” includes transfers of a drug between health care entities or from a health care entity to a retail pharmacy undertaken to alleviate temporary shortages of the drug arising from delays in or interruptions of regular distribution schedules.
A meeting under clause (i) may—
address the standards and requirements for market approval or clearance of the combination product;
address other issues relevant to such combination product, such as requirements related to postmarket modification of such combination product and good manufacturing practices applicable to such combination product; and
identify elements under subclauses (I) and (II) that may be more appropriate for discussion and agreement with the Secretary at a later date given that scientific or other information is not available, or agreement is otherwise not feasible regarding such elements, at the time a request for such meeting is made.
Any agreement under this subparagraph shall be in writing and made part of the administrative record by the Secretary.
Any such agreement shall remain in effect, except—
upon the written agreement of the Secretary and the sponsor or applicant; or
pursuant to a decision by the director of the reviewing division of the primary agency center, or a person more senior than such director, in consultation with consulting centers and the Office, as appropriate, that an issue essential to determining whether the standard for market clearance or other applicable standard under this chapter or the Public Health Service Act [42 U.S.C. 201
et seq.] applicable to the combination product has been identified since the agreement was reached, or that deviating from the agreement is otherwise justifiable based on scientific evidence, for public health reasons.
For purposes of conducting the premarket review of a combination product that contains an approved constituent part described in paragraph (4), the Secretary may require that the sponsor of such combination product submit to the Secretary only data or information that the Secretary determines is necessary to meet the standard for clearance or approval, as applicable, under this chapter or the Public Health Service Act, including any incremental risks and benefits posed by such combination product, using a risk-based approach and taking into account any prior finding of safety and effectiveness or substantial equivalence for the approved constituent part relied upon by the applicant in accordance with paragraph (5).
For purposes of paragraph (3), an approved constituent part is—
a drug constituent part of a combination product being reviewed in a single application or request under section 360e, 360(k), or 360c(f)(2) of this title (submitted in accordance with paragraph (5)), that is an approved drug, provided such application or request complies with paragraph (5);
any constituent part that was previously approved, cleared, or classified under section 355, 360(k), 360c(f)(2), or 360e of this title for which the sponsor has a right of reference or any constituent part that is a nonprescription drug, as defined in section 379aa(a)(2) of this title
If an application is submitted under section 360e or 360(k) of this title or a request is submitted under section 360c(f)(2) of this title
, consistent with any determination made under paragraph (1)(D), for a combination product containing as a constituent part an approved drug—
For purposes of this paragraph and paragraph (4), the term “approved drug” means an active ingredient—
where such application is relied upon by the applicant submitting the application or request described in subparagraph (A);
for which full reports of investigations that have been made to show whether such drug is safe for use and whether such drug is effective in use were not conducted by or for the applicant submitting the application or request described in subparagraph (A); and
for which the applicant submitting the application or request described in subparagraph (A) has not obtained a right of reference or use from the person by or for whom the investigations described in clause (iii) were conducted.
The following provisions shall apply with respect to an application or request described in subparagraph (A) to the same extent and in the same manner as if such application or request were an application described in section 355(b)(2) of this title
that referenced the approved drug:
Nothing in this subsection shall be construed as prohibiting a sponsor from submitting separate applications for the constituent parts of a combination product, unless the Secretary determines that a single application is necessary.
Nothing in this subsection shall prevent the Secretary from using any agency resources of the Food and Drug Administration necessary to ensure adequate review of the safety, effectiveness, or substantial equivalence of an article.
Not later than 60 days after October 26, 2002, the Secretary shall establish within the Office of the Commissioner of Food and Drugs an office to ensure the prompt assignment of combination products to agency centers, the timely and effective premarket review of such products, and consistent and appropriate postmarket regulation of like products subject to the same statutory requirements to the extent permitted by law. Additionally, the office shall, in determining whether a product is to be designated a combination product, consult with the component within the Office of the Commissioner of Food and Drugs that is responsible for such determinations. Such office (referred to in this paragraph as the “Office”) shall have appropriate scientific and medical expertise, and shall be headed by a director.
In carrying out this subsection, the Office shall, for each combination product, promptly assign an agency center with primary jurisdiction in accordance with paragraph (1) for the premarket review of such product.
In order to ensure the timeliness and alignment of the premarket review of a combination product, the agency center with primary jurisdiction for the product, and the consulting agency center, shall be responsible to the Office with respect to the timeliness and alignment of the premarket review.
The Office shall ensure that, with respect to a combination product, a designated person or persons in the primary agency center is the primary point or points of contact for the sponsor of such combination product. The Office shall also coordinate communications to and from any consulting center involved in such premarket review, if requested by such primary agency center or any such consulting center. Agency communications and commitments, to the extent consistent with other provisions of law and the requirements of all affected agency centers, from the primary agency center shall be considered as communication from the Secretary on behalf of all agency centers involved in the review.
The Office shall, with respect to the premarket review of a combination product—
ensure that any meeting between the Secretary and the sponsor of such product is attended by each agency center involved in the review, as appropriate;
ensure that each consulting agency center has completed its premarket review and provided the results of such review to the primary agency center in a timely manner; and
ensure that each consulting center follows the guidance described in clause (vi) and advises, as appropriate, on other relevant regulations, guidances, and policies.
In seeking agency action with respect to a combination product, the sponsor of such product—
shall identify the product as a combination product; and
may request in writing the participation of representatives of the Office in meetings related to such combination product, or to have the Office otherwise engage on such regulatory matters concerning the combination product.
Not later than 4 years after December 13, 2016, and after a public comment period of not less than 60 calendar days, the Secretary shall issue a final guidance that describes—
the structured process for managing pre-submission interactions with sponsors developing combination products;
the best practices for ensuring that the feedback in such pre-submission interactions represents the Agency’s best advice based on the information provided during such pre-submission interactions;
So in original. The word “and” probably should appear.
the information that is required to be submitted with a meeting request under paragraph (2), how such meetings relate to other types of meetings in the Food and Drug Administration, and the form and content of any agreement reached through a meeting under such paragraph (2);
So in original. The semicolon probably should be a period.
In carrying out this subsection, the Office shall ensure the consistency and appropriateness of postmarket regulation of like products subject to the same statutory requirements to the extent permitted by law.
Any dispute regarding the timeliness of the premarket review of a combination product may be presented to the Office for resolution, unless the dispute is clearly premature.
During the review process, any dispute regarding the substance of the premarket review may be presented to the Commissioner of Food and Drugs after first being considered by the agency center with primary jurisdiction of the premarket review, under the scientific dispute resolution procedures for such center. The Commissioner of Food and Drugs shall consult with the Director of the Office in resolving the substantive dispute.
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 (except with respect to clause (iv), beginning not later than one year after December 13, 2016), and annually thereafter, the Secretary shall report to the appropriate committees of Congress on the activities and impact of the Office. The report shall include provisions—
describing the numbers and types of combination products under review and the timeliness in days of such assignments, reviews, and dispute resolutions;
identifying the number of premarket reviews of such products that involved a consulting agency center;
describing improvements in the consistency of postmarket regulation of combination products; and
identifying the percentage of combination products for which a dispute resolution, with respect to premarket review, was requested by the combination product’s sponsor.
Nothing in this paragraph shall be construed to limit the regulatory authority of any agency center.
As used in this subsection:
The term “agency center” means a center or alternative organizational component of the Food and Drug Administration.
The term “biological product” has the meaning given the term in section 351(i) of the Public Health Service Act (42 U.S.C. 262
The term “market clearance” includes—
approval of an application under section 355, 357,
See References in Text note below.
360e, or 360j(g) of this title;
a finding of substantial equivalence under this part;
approval of a biologics license application under subsection (a) of section 351 of the Public Health Service Act (42 U.S.C. 262
The terms “premarket review” and “reviews” include all activities of the Food and Drug Administration conducted prior to approval or clearance of an application, notification, or request for classification submitted under section 355, 360(k), 360c(f)(2), 360e, or 360j of this title or under section 351 of the Public Health Service Act [42 U.S.C. 262
], including with respect to investigational use of the product.
[June 25, 1938, ch. 675, § 503], [52 Stat. 1051]; [Oct. 26, 1951, ch. 578, § 1], [65 Stat. 648]; [Pub. L. 87–781, title I, § 104(e)(2)], Oct. 10, 1962, [76 Stat. 785]; [Pub. L. 91–601, § 6(e)], formerly § 7(e), Dec. 30, 1970, [84 Stat. 1673], renumbered [Pub. L. 97–35, title XII, § 1205(c)], Aug. 13, 1981, [95 Stat. 716]; [Pub. L. 100–293], §§ 4–6, Apr. 22, 1988, [102 Stat. 96–98]; [Pub. L. 100–670, title I, § 105], Nov. 16, 1988, [102 Stat. 3983]; [Pub. L. 101–629, § 16(a)], Nov. 28, 1990, [104 Stat. 4526]; [Pub. L. 102–108, § 2(d)], Aug. 17, 1991, [105 Stat. 550]; [Pub. L. 102–300, § 6(d)], June 16, 1992, [106 Stat. 240]; [Pub. L. 102–353], §§ 2(a)–(c), 4, Aug. 26, 1992, [106 Stat. 941], 942; [Pub. L. 104–250, § 5(a)], Oct. 9, 1996, [110 Stat. 3155]; [Pub. L. 105–115, title I], §§ 123(e), 126(a), (c)(1), (2), Nov. 21, 1997, [111 Stat. 2324], 2327, 2328; [Pub. L. 107–250, title II, § 204], Oct. 26, 2002, [116 Stat. 1611]; [Pub. L. 108–282, title I, § 102(b)(5)(F)], Aug. 2, 2004, [118 Stat. 903]; [Pub. L. 113–54, title II, § 204(a)(1)]–(4), (b), Nov. 27, 2013, [127 Stat. 630–635]; [Pub. L. 114–255, div. A, title III, § 3038(a)], Dec. 13, 2016, [130 Stat. 1105].)