21 U.S.C. § 384 — Importation of prescription drugs

submitted 88 years ago by Pub. L. 108-173 to r/title-21-FOOD-AND-DRUGS · 1,997 words · no verdicts yet

in plain englishAI-generated · not legal advice

This law lets the Secretary allow licensed pharmacists and wholesalers to import prescription drugs from Canada. It sets strict safety rules, recordkeeping, and testing requirements. It also lets the Secretary waive the import ban for individuals bringing in small amounts for personal use.

(a) Definitions. This section defines key words. An "importer" is a pharmacist or wholesaler. A "pharmacist" is a person a State has licensed to practice pharmacy, including selling prescription drugs. A "prescription drug" is a drug that needs a prescription under section 353(b), but it does NOT include: (A) controlled substances; (B) biological products; (C) infused drugs, like dialysis solution; (D) drugs given through an IV; (E) drugs inhaled during surgery; or (F) injectable drugs the Secretary decides are too risky to import this way — those stay under the older rule in section 381(d)(1). A "qualifying laboratory" is a U.S. lab the Secretary has approved for this section. A "wholesaler" is a business licensed to distribute prescription drugs under section 353(e)(2)(A), but it does not include anyone already allowed to import drugs under section 381(d)(1). (b) Regulations. After talking with the U.S. Trade Representative and Customs and Border Protection, the Secretary must write rules letting pharmacists and wholesalers import prescription drugs from Canada. (c) Limitation. Those rules must: (1) make sure every imported drug meets the safety and effectiveness standards in sections 355, 351, and 352, and other rules in this chapter; (2) require importers to follow the recordkeeping rules in subsection (d)(1) and the testing rules in subsection (e); and (3) include any other safeguards the Secretary thinks are needed to protect public health or to make importing easier. (d) Information and records. (1) The rules must require importers to give the Secretary detailed paperwork for each shipment, including: the drug's active ingredient and amount; its dosage form; the ship date and quantity; where it came from and where it's going; the price paid; proof from the foreign seller of where the drug originally came from and how much of that batch the seller got; the manufacturer's lot number; the importer's name, address, phone number, and license number; and, if the drug came straight from the manufacturer's first foreign buyer, proof of that chain of custody and proof the drug was tested for authenticity and quality (full testing on the first shipment, sample testing after that). If the drug did NOT come straight from that first foreign buyer, every batch in every shipment must be sampled and tested. Importers must also give a certification that the drug is approved for sale in the U.S., is not fake or mislabeled, and meets all labeling rules; lab records proving it meets required standards; proof the testing happened at a qualifying laboratory; and any other information the Secretary says is needed to protect public health. (2) The Secretary must keep all this paperwork for as long as the Secretary decides is necessary. (e) Testing. The rules must require: (1) that the required testing be done by the importer or by the drug's manufacturer, at a qualifying laboratory; (2) if the importer does the testing, the manufacturer must give the importer the information needed to prove the drug is genuine and that its labeling is correct, and that information must be kept strictly confidential and used only for testing or compliance; and (3) the rules may include extra protections for trade secrets and confidential business information. (f) Registration of foreign sellers. Any business in Canada that distributes a prescription drug imported (or offered for import) into the U.S. must register its name, business address, and its U.S. agent with the Secretary. (g) Suspension of importation. If the Secretary sees a pattern of counterfeit or rule-breaking drugs coming from a specific drug or a specific importer, the Secretary must immediately stop those imports until an investigation shows the public is safe. (h) Approved labeling. The drug's manufacturer must give the importer free written permission to use the drug's approved label. (i) Charitable contributions. This whole section does not apply to a drug a manufacturer donates for free to a charity (including the United Nations) or to a foreign government — those stay under the older rule in section 381(d)(1). (j) Waiver authority for importation by individuals. (1) Congress says that when enforcing the import ban against individuals, the Secretary should focus on cases that pose a real health risk, and should use discretion to let people import drugs when it's clearly for personal use and doesn't look unreasonably risky. (2) The Secretary may grant individuals a waiver from the import ban, by rule or case by case, under conditions the Secretary sets. The Secretary must publish guidance describing when these case-by-case waivers will be granted, so people know in advance if their import will be allowed. (3) In particular, the Secretary must write a rule letting individuals import a prescription drug from Canada if: (A) it's for personal use only, not resale, and no more than a 90-day supply; (B) it comes with a copy of a valid prescription; (C) it comes from a licensed Canadian pharmacy registered with the Secretary; (D) it's a drug the Secretary has approved under subchapter V; (E) it's in its final finished form and made at a facility registered under section 360; and (F) it meets any other conditions the Secretary sets to protect public safety. (k) Construction. Nothing here limits the Secretary's other powers over drug imports, except as this section changes how section 381(d)(1) applies. (l) Effectiveness of section. (1) This whole section only takes effect once the Secretary certifies to Congress that it will pose no extra risk to public health and will meaningfully cut costs for American consumers. (2) The program can end early: if, between 1 and 18 months after the rules take effect, the Secretary certifies to Congress that the risks outweigh the benefits based on real evidence, the section stops working 30 days later. Before making that certification, the Secretary must hold a formal hearing and must: (i) find it's more likely than not that the program increases health risk, spell out that risk in detail, identify its causes, consider ways to reduce the risk, and tell Congress if fixing it needs new legislation; (ii) spell out the program's benefits in detail, including savings for consumers; and (iii) compare the risks and benefits and conclude the risks are worse. (m) Authorization of appropriations. Congress may appropriate whatever money is needed to carry out this section.

the actual law source: uscode.house.gov ↗public domain

(a) Definitions

In this section:

(1) Importer

The term “importer” means a pharmacist or wholesaler.

(2) Pharmacist

The term “pharmacist” means a person licensed by a State to practice pharmacy, including the dispensing and selling of prescription drugs.

(3) Prescription drug

The term “prescription drug” means a drug subject to section 353(b) of this title, other than—

(A)

a controlled substance (as defined in section 802 of this title);

(B)

a biological product (as defined in section 262 of title 42);

(C)

an infused drug (including a peritoneal dialysis solution);

(D)

an intravenously injected drug;

(E)

a drug that is inhaled during surgery; or

(F)

a drug which is a parenteral drug, the importation of which pursuant to subsection (b) is determined by the Secretary to pose a threat to the public health, in which case section 381(d)(1) of this title shall continue to apply.

(4) Qualifying laboratory

The term “qualifying laboratory” means a laboratory in the United States that has been approved by the Secretary for the purposes of this section.

(5) Wholesaler

(A) In general

The term “wholesaler” means a person licensed as a wholesaler or distributor of prescription drugs in the United States under section 353(e)(2)(A) of this title.

(B) Exclusion

The term “wholesaler” does not include a person authorized to import drugs under section 381(d)(1) of this title.

(b) Regulations

The Secretary, after consultation with the United States Trade Representative and the Commissioner of U.S. Customs and Border Protection, shall promulgate regulations permitting pharmacists and wholesalers to import prescription drugs from Canada into the United States.

The regulations under subsection (b) shall—

(1)

require that safeguards be in place to ensure that each prescription drug imported under the regulations complies with section 355 of this title (including with respect to being safe and effective for the intended use of the prescription drug), with sections 351 and 352 of this title, and with other applicable requirements of this chapter;

(2)

require that an importer of a prescription drug under the regulations comply with subsections (d)(1) and (e); and

(3)

contain any additional provisions determined by the Secretary to be appropriate as a safeguard to protect the public health or as a means to facilitate the importation of prescription drugs.

(d) Information and records

(1) In general

The regulations under subsection (b) shall require an importer of a prescription drug under subsection (b) to submit to the Secretary the following information and documentation:

(A)

The name and quantity of the active ingredient of the prescription drug.

(B)

A description of the dosage form of the prescription drug.

(C)

The date on which the prescription drug is shipped.

(D)

The quantity of the prescription drug that is shipped.

(E)

The point of origin and destination of the prescription drug.

(F)

The price paid by the importer for the prescription drug.

(G)

Documentation from the foreign seller specifying—

(i)

the original source of the prescription drug; and

(ii)

the quantity of each lot of the prescription drug originally received by the seller from that source.

(H)

The lot or control number assigned to the prescription drug by the manufacturer of the prescription drug.

(I)

The name, address, telephone number, and professional license number (if any) of the importer.

(J)

(i)

In the case of a prescription drug that is shipped directly from the first foreign recipient of the prescription drug from the manufacturer:

(I)

Documentation demonstrating that the prescription drug was received by the recipient from the manufacturer and subsequently shipped by the first foreign recipient to the importer.

(II)

Documentation of the quantity of each lot of the prescription drug received by the first foreign recipient demonstrating that the quantity being imported into the United States is not more than the quantity that was received by the first foreign recipient.

(III)

(aa)

In the case of an initial imported shipment, documentation demonstrating that each batch of the prescription drug in the shipment was statistically sampled and tested for authenticity and degradation.

(bb)

In the case of any subsequent shipment, documentation demonstrating that a statistically valid sample of the shipment was tested for authenticity and degradation.

(ii)

In the case of a prescription drug that is not shipped directly from the first foreign recipient of the prescription drug from the manufacturer, documentation demonstrating that each batch in each shipment offered for importation into the United States was statistically sampled and tested for authenticity and degradation.

(K)

Certification from the importer or manufacturer of the prescription drug that the prescription drug—

(i)

is approved for marketing in the United States and is not adulterated or misbranded; and

(ii)

meets all labeling requirements under this chapter.

(L)

Laboratory records, including complete data derived from all tests necessary to ensure that the prescription drug is in compliance with established specifications and standards.

(M)

Documentation demonstrating that the testing required by subparagraphs (J) and (L) was conducted at a qualifying laboratory.

(N)

Any other information that the Secretary determines is necessary to ensure the protection of the public health.

(2) Maintenance by the Secretary

The Secretary shall maintain information and documentation submitted under paragraph (1) for such period of time as the Secretary determines to be necessary.

(e) Testing

The regulations under subsection (b) shall require—

(1)

that testing described in subparagraphs (J) and (L) of subsection (d)(1) be conducted by the importer or by the manufacturer of the prescription drug at a qualified laboratory;

(2)

if the tests are conducted by the importer—

(A)

that information needed to—

(i)

authenticate the prescription drug being tested; and

(ii)

confirm that the labeling of the prescription drug complies with labeling requirements under this chapter;

be supplied by the manufacturer of the prescription drug to the pharmacist or wholesaler; and

(B)

that the information supplied under subparagraph (A) be kept in strict confidence and used only for purposes of testing or otherwise complying with this chapter; and

(3)

may include such additional provisions as the Secretary determines to be appropriate to provide for the protection of trade secrets and commercial or financial information that is privileged or confidential.

(f) Registration of foreign sellers

Any establishment within Canada engaged in the distribution of a prescription drug that is imported or offered for importation into the United States shall register with the Secretary the name and place of business of the establishment and the name of the United States agent for the establishment.

(g) Suspension of importation

The Secretary shall require that importations of a specific prescription drug or importations by a specific importer under subsection (b) be immediately suspended on discovery of a pattern of importation of that specific prescription drug or by that specific importer of drugs that are counterfeit or in violation of any requirement under this section, until an investigation is completed and the Secretary determines that the public is adequately protected from counterfeit and violative prescription drugs being imported under subsection (b).

(h) Approved labeling

The manufacturer of a prescription drug shall provide an importer written authorization for the importer to use, at no cost, the approved labeling for the prescription drug.

(i) Charitable contributions

Notwithstanding any other provision of this section, section 381(d)(1) of this title continues to apply to a prescription drug that is donated or otherwise supplied at no charge by the manufacturer of the drug to a charitable or humanitarian organization (including the United Nations and affiliates) or to a government of a foreign country.

(j) Waiver authority for importation by individuals

(1) Declarations

Congress declares that in the enforcement against individuals of the prohibition of importation of prescription drugs and devices, the Secretary should—

(A)

focus enforcement on cases in which the importation by an individual poses a significant threat to public health; and

(B)

exercise discretion to permit individuals to make such importations in circumstances in which—

(i)

the importation is clearly for personal use; and

(ii)

the prescription drug or device imported does not appear to present an unreasonable risk to the individual.

(2) Waiver authority

(A) In general

The Secretary may grant to individuals, by regulation or on a case-by-case basis, a waiver of the prohibition of importation of a prescription drug or device or class of prescription drugs or devices, under such conditions as the Secretary determines to be appropriate.

(B) Guidance on case-by-case waivers

The Secretary shall publish, and update as necessary, guidance that accurately describes circumstances in which the Secretary will consistently grant waivers on a case-by-case basis under subparagraph (A), so that individuals may know with the greatest practicable degree of certainty whether a particular importation for personal use will be permitted.

(3) Drugs imported from Canada

In particular, the Secretary shall by regulation grant individuals a waiver to permit individuals to import into the United States a prescription drug that—

(A)

is imported from a licensed pharmacy for personal use by an individual, not for resale, in quantities that do not exceed a 90-day supply;

(B)

is accompanied by a copy of a valid prescription;

(C)

is imported from Canada, from a seller registered with the Secretary;

(D)

is a prescription drug approved by the Secretary under subchapter V;

(E)

is in the form of a final finished dosage that was manufactured in an establishment registered under section 360 of this title; and

(F)

is imported under such other conditions as the Secretary determines to be necessary to ensure public safety.

(k) Construction

Nothing in this section limits the authority of the Secretary relating to the importation of prescription drugs, other than with respect to section 381(d)(1) of this title as provided in this section.

(l) Effectiveness of section

(1) Commencement of program

This section shall become effective only if the Secretary certifies to the Congress that the implementation of this section will—

(A)

pose no additional risk to the public’s health and safety; and

(B)

result in a significant reduction in the cost of covered products to the American consumer.

(2) Termination of program

(A) In general

If, after the date that is 1 year after the effective date of the regulations under subsection (b) and before the date that is 18 months after the effective date, the Secretary submits to Congress a certification that, in the opinion of the Secretary, based on substantial evidence obtained after the effective date, the benefits of implementation of this section do not outweigh any detriment of implementation of this section, this section shall cease to be effective as of the date that is 30 days after the date on which the Secretary submits the certification.

(B) Procedure

The Secretary shall not submit a certification under subparagraph (A) unless, after a hearing on the record under sections 556 and 557 of title 5, the Secretary—

(i)

(I)

determines that it is more likely than not that implementation of this section would result in an increase in the risk to the public health and safety;

(II)

identifies specifically, in qualitative and quantitative terms, the nature of the increased risk;

(III)

identifies specifically the causes of the increased risk; and

(IV)

(aa)

considers whether any measures can be taken to avoid, reduce, or mitigate the increased risk; and

(bb)

if the Secretary determines that any measures described in item (aa) would require additional statutory authority, submits to Congress a report describing the legislation that would be required;

(ii)

identifies specifically, in qualitative and quantitative terms, the benefits that would result from implementation of this section (including the benefit of reductions in the cost of covered products to consumers in the United States, allowing consumers to procure needed medication that consumers might not otherwise be able to procure without foregoing other necessities of life); and

(iii)

(I)

compares in specific terms the detriment identified under clause (i) with the benefits identified under clause (ii); and

(II)

determines that the benefits do not outweigh the detriment.

(m) Authorization of appropriations

There are authorized to be appropriated such sums as are necessary to carry out this section.

Source credit: (June 25, 1938, ch. 675, § 804, as added Pub. L. 108–173, title XI, § 1121(a), Dec. 8, 2003, 117 Stat. 2464; amended Pub. L. 114–125, title VIII, § 802(d)(2), Feb. 24, 2016, 130 Stat. 210.)

history & why it existsrecord from the source credit

1938Enacted · Pub. L. 108-173 · 117 Stat. 2464
2016Amended · Pub. L. 114-125 · 130 Stat. 210

A history note hasn’t been published yet. The record shows enactment by Pub. L. 108-173 on 1938-06-25.

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