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S 1848 99th Congress Senate Foreign Trade and International Finance Advice and consent of the Senate Agriculture and Food Alcohol Child nutrition Congressional-Presidential relations Consumer goods Consumer protection Cosmetics and personal care Drug adulteration Drug industry Drugs Drugs and narcotics Environmental Protection Export controls Exports Federal officials Food additives Food adulteration and inspection Foreign Trade and Investments

Pharmaceutical Export Amendments of 1985

Introduced: November 13, 1985 See on congress.gov
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This bill died when the 99th Congress ended
It never became law before the 99th Congress (1985–1986) adjourned, and bills don't carry over to the next Congress. It would have to be reintroduced. You can still save it for reference, but it won't receive updates.
 Everywhere this bill has been 16 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Oct 18, 1986
Provisions of This Bill Were Incorporated in S.1744.
May 30, 1986
Referred to Subcommittee on International Economic Policy and Trade.
May 22, 1986
Referred to Subcommittee on Health and the Environment.
May 20, 1986
Referred to House Committee on Energy and Commerce.
May 20, 1986
Referred to House Committee on Foreign Affairs.
May 14, 1986
Passed Senate with amendments by Yea-Nay Vote. 91-7. Record Vote No: 99.
May 14, 1986
Passed/agreed to in Senate: Passed Senate with amendments by Yea-Nay Vote. 91-7. Record Vote No: 99.
May 14, 1986
Considered by Senate.
May 13, 1986
Considered by Senate.
May 12, 1986
Considered by Senate.
May 8, 1986
Measure laid before Senate by unanimous consent.
Dec 18, 1985
Placed on Senate Legislative Calendar under General Orders. Calendar No. 493.
Dec 18, 1985
Committee on Labor and Human Resources. Reported to Senate by Senator Hatch with an amendment in the nature of a substitute. With written report No. 99-225. Minority views filed.
Nov 19, 1985
Committee on Labor and Human Resources. Ordered to be reported with an amendment in the nature of a substitute favorably.
Nov 13, 1985
Read twice and referred to the Committee on Labor and Human Resources.
Nov 13, 1985
Introduced in Senate
 Amendments to this bill 35

Amendments propose changes to this bill. Members vote on amendments separately before the final bill vote. An agreed amendment becomes part of the bill; a failed amendment does not.

9 agreed to 26 pending / other

AmendmentSponsorPurposeStatusLatest action
SAMDT 1,957 – To require that the government of a tier II country have an adequate governmental health authority to obtain … Agreed to May 14, 1986
SAMDT 1,956 – To establish the Food and Drug Administration by law, and for other purposes. Agreed to May 14, 1986
SAMDT 1,955 – To require the Office of Technology Assessment to conduct a study on the labeling of drugs sold in foreign co… Agreed to May 14, 1986
SAMDT 1,954 – To prohibit the shipment of a drug from the United States if the drug is found to be in a country to which sh… Agreed to May 13, 1986
SAMDT 1,953 – To reform certain regulatory procedures governing the export of banned and severely restricted substances. Agreed to May 13, 1986
SAMDT 1,952 – To require that, to be exported, any unapproved drug must be the subject of a new drug application. Agreed to May 13, 1986
SAMDT 1,950 – To require that the same conditions apply to the export of antibiotic drugs as apply to other drugs. Agreed to May 13, 1986
SAMDT 1,949 – To require the Secretary to enter into agreements to obtain information about the export of drugs. Agreed to May 13, 1986
SAMDT 1,948 – To amend section 412 of the Federal Food, Drug, and Cosmetic Act, relating to requirements for infant formula… Agreed to May 13, 1986
SAMDT 1,619 – To require the Comptroller General of the United States to conduct a study on the efficacy of provisions desi… Pending –
SAMDT 1,618 – To require that a drug may be shipped to a tier II country if the drug is approved or licensed by at least ha… Pending –
SAMDT 1,617 – To require the Secretary to enter into agreements to obtain information about the export of drugs. Pending –
SAMDT 1,616 – To require that persons shipping drugs to report to the Secretary information concerning drugs exported abroa… Pending –
SAMDT 1,615 – To provide that the authority to export drugs terminates two years after the date of enactment of this Act. Pending –
SAMDT 1,614 – To require that the labeling of an exported drug state that the drug is not approved for sale or use in the U… Pending –
SAMDT 1,613 – To prohibit the shipment of a drug from the United States if the drug is found to be present in a country to … Pending –
SAMDT 1,612 – To require that the Secretary or the Secretary of Agriculture to prohibit the shipment of a drug to a country… Pending –
SAMDT 1,611 – To require that the Secretary of Agriculture promulgate regulations to ensure proper enforcement. Pending –
SAMDT 1,610 – To require that the government of a tier II country have an adequate governmental health authority to obtain … Pending –
SAMDT 1,609 – To require the Secretary of Health and Human Services to affirmatively determine which countries are to be in… Pending –
SAMDT 1,608 – To require public comment with respect to the shipment of drugs. Pending –
SAMDT 1,607 – To limit the types of drugs which may be shipped to tier III countries to drugs for the treatment of vector-b… Pending –
SAMDT 1,606 – To prohibit the shipment of a drug which has been withdrawn from sale or use in the United States. Pending –
SAMDT 1,605 – To prohibit the shipment to tier II countries of a drug which has been withdrawn from sale or use in a tier I… Pending –
SAMDT 1,604 – To require that persons shipping drugs report to the Secretary information concerning drugs exported abroad, … Pending –
SAMDT 1,603 – To permit enforcement through civil actions. Pending –
SAMDT 1,602 – To eliminate the shipment of drugs to tier II countries, and to require that tier I countries have standards … Pending –
SAMDT 1,601 – To require that, to be exported, any unapproved drug must be the subject of a new drug application. Pending –
SAMDT 1,600 – To permit the export of a drug to a country only if the Secretary of Health and Human Services or the Secreta… Pending –
SAMDT 1,599 – To require that the Secretary determine that an unapproved drug is a biotechnology drug in order for the drug… Pending –
SAMDT 1,598 – To prohibit the export of a drug which is approved for use in the United States if the manufacturer of the dr… Pending –
SAMDT 1,597 – To require that the same conditions apply to the export of antibiotic drugs as apply to other drugs. Pending –
SAMDT 1,595 – To require the appointment of the Commissioner of Food and Drugs to be subject to Senate confirmation. Pending –
SAMDT 1,594 – To amend the Federal Food, Drug, and Cosmetic Act to require that the label of all drugs disclose the active … Pending –
SAMDT 1,593 – To repeal provisions of law authorizing the provisional listing of color additives. Pending –
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 Plain-English summary Congressional Research Service

Pharmaceutical Export Amendments of 1985 - Amends the Federal Food, Drug, and Cosmetic Act to permit the export of certain drugs (including biological products) intended for human or animal use even though such drugs have not been approved or licensed for use in the United States.

Directs the Secretary of Health and Human Services to establish and update a two-tiered list of countries with adequate governmental health authorities which in the first tier includes developed regulatory procedures and tests with experienced scientific personnel and in the second tier includes sufficient ability to assure consistency of labeling information. Permits shipments to nonlist countries where differing health conditions make such shipments desirable, e.g. tropical diseases.

Permits the export of an unapproved drug to a second tier country if such drug is approved for use in any first-tier country and not banned for use in any first-tier country.

Prohibits the export of drugs denied approval on the basis of safety and efficacy or whose manufacture in the United States has been determined to be contrary to U.S. health and safety.

Sets forth other criteria and restrictions on the export of such drugs, including notice requirements on shipments and notice of and opportunity to cure deficiencies in such shipments. Permits the Secretaries of Agriculture and Health and Human Services to prohibit noncomplying shipments and shipments otherwise permitted if either Secretary determines a shipment would present an imminent hazard to the public health of the recipient country.

Requires the Comptroller General to report biennially to the Secretary of Health and Human Services and the Congress on the extent to which drugs unauthorized for a country are being received by such country and the extent to which labeling is consistent.

Directs the Secretary to contract for a study to be submitted to the Congress within five years on the economic and international health impact of this Act.

Includes condition prevalent in a developing country among the criteria for orphan drugs.

What's happening now October 18, 1986

Provisions of This Bill Were Incorporated in S.1744.

 Related & companion bills 1
  • S 1744 Related bill State Comprehensive Mental Health Services Plan Act of 1986
 Committees of jurisdiction 5
 Cosponsors 1
All 1 Republican 1
R
McConnell, Mitch
Kentucky · Feb 5, 1986
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APA
U.S. Congress. (2026). S. 1848: Pharmaceutical Export Amendments of 1986. 99th Congress. Open America. https://openamerica.io/bill/99-S-1848/
MLA
"S. 1848: Pharmaceutical Export Amendments of 1986." 99th Congress, 2026, Open America, https://openamerica.io/bill/99-S-1848/.
Bluebook (legal)
S. 1848, 99th Cong. (2026), https://openamerica.io/bill/99-S-1848/.
Markdown link
[S. 1848: Pharmaceutical Export Amendments of 1986](https://openamerica.io/bill/99-S-1848/)
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