Sec. 4. National standards for wholesale distributors
1,287 words·~6 min read·
/bill/113/hr/1919/eh/section-4A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Chapter V of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 351 et seq. ) is amended— in section 503 ( 21 U.S.C. 353 ), by striking (e)(1)(A) and all that follows through
(3)For the purposes of this subsection and subsection (d)— and inserting the following: For purposes of subsection (d)— ; in section 503(e) ( 21 U.S.C. 353(e) ), by redesignating subparagraphs
(A)and
(B)as paragraphs
(1)and (2), respectively; and in subchapter H, as added by section 2, by adding at the end the following: The Secretary shall establish, by regulation, standards for the licensing of persons that make wholesale distributions. The standards under paragraph
(1)shall, with respect to wholesale distributions, include requirements for— the storage and handling of drugs subject to section 503(b)(1), including facility requirements; the establishment and maintenance of records of the distributions of such drugs; the furnishing of a bond or other equivalent means of security in accordance with paragraph (3); mandatory background checks and fingerprinting of facility managers or designated representatives; the establishment and implementation of qualifications for key personnel; the mandatory physical inspection of any facility to be used in wholesale distribution within a reasonable timeframe from the initial application for licensure of the wholesale distributor; and in accordance with paragraph (5), the prohibition of certain persons from engaging in wholesale distribution. The requirements under paragraph (2)(C) shall provide for the following: An applicant that is not a government-owned-and-operated wholesale distributor, for the issuance or renewal of a wholesale distributor license, shall submit a surety bond of $100,000 or other equivalent means of security acceptable to the applicable licensing authority. For purposes of subparagraph (A), the applicable licensing authority may accept a surety bond of less than $100,000 if the annual gross receipts of the previous tax year for the wholesale distributor is $10,000,000 or less, in which case the surety bond may not be less than $25,000. If a wholesale distributor can provide evidence that it possesses the required bond in a State, the requirement for a bond in another State is waived. To satisfy the inspection requirement under paragraph (2)(F), the Secretary may conduct the inspection, or may accept an inspection by— the government of the State in which the facility is located; or a third-party accreditation or inspection service approved by the Secretary. The requirements under paragraph
(2)shall include requirements to prohibit a person from receiving or maintaining licensure for wholesale distribution if the person— has been convicted of— any felony for conduct relating to wholesale distribution; any felony violation of section 301(i) or 301(k); or any felony violation of section 1365 of title 18, United States Code, relating to prescription drug product tampering; or has engaged in a pattern of violating the requirements of this section that presents a threat of serious adverse health consequences or death to humans. Beginning not later than 1 year after the date of the enactment of this section, each person engaged in wholesale distribution in interstate commerce shall submit on an annual basis, and update as necessary, a report to the Secretary including— the wholesale distributor’s name; the wholesale distributor’s address; a listing of each State in which the wholesale distributor is licensed for wholesale distribution; and any disciplinary actions taken by a State, the Federal Government, or a foreign government during the reporting period against the wholesale distributor. The Secretary shall post on the public Internet Website of the Food and Drug Administration the name of each wholesale distributor, and the State in which each such distributor is licensed, based on reports under paragraph (1). This subchapter does not prohibit a State from— licensing wholesale distributors for the conduct of wholesale distribution activities in the State in accordance with this subchapter; and collecting fees from wholesale distributors in connection with such licensing, so long as the State does not require such licensure to the extent to which an entity is engaged in third-party logistics provider activities. In this section, the term wholesale distribution means the distribution of a drug subject to section 503(b)(1) to a person other than a consumer or patient, but does not include— intracompany distribution of any drug between members of an affiliated group (as defined in section 1504(a) of the Internal Revenue Code of 1986); the distribution of a drug, or an offer to distribute a drug among hospitals or other health care entities which are under common control; 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 319 of the Public Health Service Act, except that a drug shortage not caused by a public health emergency shall not constitute such an emergency medical reason; dispensing of a drug pursuant to a valid prescription executed in accordance with subsection 503(b)(1); the distribution of minimal quantities of drug by a licensed retail pharmacy to a licensed practitioner for office use; 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; 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; the distribution of a drug by the manufacturer of such drug; 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; the transport of a drug by a common carrier, provided that the common carrier does not take ownership of the drug; the distribution of a drug, or an offer to distribute a drug, by an authorized repackager that has taken ownership of the drug and repacked it in accordance with section 582(e); saleable drug returns when conducted by a dispenser in accordance with section 203.23 of title 21, Code of Federal Regulations (or any successor regulation); the distribution of a combination prescription drug product described in section 581(20)(B)(xii); the distribution of a medical convenience kit described in section 581(21)(B)(xiii); 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); the distribution of an intravenous drug used to maintain the equilibrium of water and minerals in the body, such as dialysis solutions; the distribution of a drug that is intended for irrigation or reconstitution, or sterile water, whether intended for such purposes or for injection; the distribution of compressed medical gas (as defined in section 581(21)(C)); facilitating the distribution of a prescription drug product by providing administrative services, such as processing of orders and payments, without physical handling, distribution, or storage of a prescription drug product; or the distribution of a product by a dispenser, or a wholesale distributor acting at the direction of the dispenser, to a repackager registered under section 510 for the purpose of repackaging the drug for use by that dispenser or another health care entity that is under the dispenser’s ownership or control, so long as the dispenser retains ownership of the prescription drug product; and the saleable or nonsaleable return by such repackager of such prescription drug product. The standards required by subsection
(a)shall take effect not later than 2 years after the date of the enactment of this section. The Secretary shall issue the regulations required by subsection
(a)not later than 1 year after the date of the enactment of this Act. . Section 804(a)(5)(A) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 384(a)(5)(A) ) is amended by striking 503(e)(2)(A) and inserting 583(a) .
Connectionstraces to 3
Citation graph
cites case law
Cites 3Cited by 0 across 0 sources