[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6543 Introduced in House (IH)]

111th CONGRESS
  2d Session
                                H. R. 6543

To amend the Federal Food, Drug, and Cosmetic Act to improve the safety 
                   of drugs, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           December 17, 2010

  Mr. Dingell (for himself, Mr. Waxman, Mr. Pallone, and Mr. Stupak) 
 introduced the following bill; which was referred to the Committee on 
                          Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
To amend the Federal Food, Drug, and Cosmetic Act to improve the safety 
                   of drugs, and for other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Drug Safety Enhancement Act of 
2011''.

SEC. 2. TABLE OF CONTENTS.

    The table of contents for this Act is as follows:

Sec. 1. Short title.
Sec. 2. Table of contents.
                          TITLE I--PREVENTION

Sec. 101. Registration of producers of drugs; applicable fee.
Sec. 102. Drug supply quality and safety.
Sec. 103. Inspection of producers of drugs.
Sec. 104. Prohibition against delaying, limiting, or refusing 
                            inspection.
Sec. 105. Clarification of inspection authority related to BIMO and IRB 
                            inspections.
Sec. 106. Notification, nondistribution, and recall of adulterated or 
                            misbranded drug products.
Sec. 107. Notification.
                           TITLE II--RESPONSE

Sec. 201. Administrative detention.
Sec. 202. Destruction of adulterated, misbranded, or counterfeit drugs 
                            offered for import.
Sec. 203. Criminal penalties.
Sec. 204. Civil penalties.
Sec. 205. Seizure.
Sec. 206. Asset forfeiture.
                 TITLE III--IMPORTATION AND EXPORTATION

Sec. 301. Documentation for admissibility of imports.
Sec. 302. Registration for commercial importers; fee.
Sec. 303. Registration for customs brokers.
Sec. 304. Exportation certificate program.
Sec. 305. Extraterritorial jurisdiction.
Sec. 306. Dedicated foreign inspectorate.
                        TITLE IV--MISCELLANEOUS

Sec. 401. Unique identification number for establishments, importers, 
                            and customs brokers.
Sec. 402. Country of origin labeling.
Sec. 403. False or misleading reporting to FDA.
Sec. 404. Subpoena authority.
Sec. 405. Whistleblower protections.
Sec. 406. Rule of construction.

                          TITLE I--PREVENTION

SEC. 101. REGISTRATION OF PRODUCERS OF DRUGS; APPLICABLE FEE.

    (a) Foreign Registrants.--
            (1) Misbranding.--Section 502(o) of the Federal, Food, 
        Drug, and Cosmetic Act (21 U.S.C. 352(o)) is amended by 
        inserting ``if it is a drug and was manufactured, prepared, 
        propagated, compounded, or processed in an establishment not 
        duly registered under section 510(i),'' after ``not duly 
        registered under section 510,''.
            (2) Application.--The amendment made by paragraph (1) 
        applies only with respect to registration (including failure to 
        register) under section 510 of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 360) occurring on or after the date of 
        the enactment of this Act.
    (b) Excipient Manufacturers.--
            (1) In general.--Not later than 6 months after the date of 
        the enactment of this Act, the Secretary of Health and Human 
        Services shall revise section 207.10 of title 21, Code of 
        Federal Regulations, and such other regulations as may be 
        necessary to require owners and operators of establishments 
        that engage in the manufacture, preparation, propagation, 
        compounding, or processing of an excipient of a drug to 
        register such establishments under section 510 of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 360).
            (2) Application.--The revisions to regulations under 
        paragraph (1) shall apply with respect to the manufacture, 
        preparation, propagation, compounding, or processing of an 
        excipient of a drug on or after the date that is 18 months 
        after the date of the enactment of this Act.
    (c) Drug Listing Elements and Frequency.--
            (1) In general.--Sections 510(j) of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 360(j)) is amended--
                    (A) in paragraph (1), by amending subparagraph (C) 
                to read as follows:
            ``(C) in the case of any drug contained in an applicable 
        list which is described in subparagraph (A) or (B), a 
        qualitative and quantitative listing of each of its active and 
        other ingredients, and any other information that the Secretary 
        finds is necessary to carry out the purposes of this Act; 
        and''; and
                    (B) in paragraph (2), in the matter preceding 
                subparagraph (A), by inserting ``, unless otherwise 
                specified by the Secretary'' after ``once during the 
                month of December of each year''.
            (2) Application.--The amendments made by paragraph (1) 
        apply with respect to the filing of a list under section 510(j) 
        of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(j)) 
        that occurs on or after the date that is 6 months after the 
        date of the enactment of this Act.
    (d) Suspension and Cancellation of Registration.--Section 510 of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j) is amended by 
adding at the end the following:
    ``(q) Suspension and Cancellation of Registration.--With respect to 
any registration under this section attributable to the manufacture, 
preparation, propagation, compounding, or processing of a drug:
            ``(1) Suspension of registration.--
                    ``(A) In general.--Registration under this section 
                is subject to suspension upon a finding by the 
                Secretary, after notice and an opportunity for an 
                informal hearing, of--
                            ``(i) a violation of this Act; or
                            ``(ii) the knowing or repeated making of an 
                        inaccurate or incomplete statement or 
                        submission of information relating to the 
                        manufacture, preparation, propagation, 
                        compounding, processing, or importing of a 
                        drug.
                    ``(B) Request.--Any person or establishment whose 
                registration is suspended under subparagraph (A) may 
                request that the Secretary vacate the suspension when 
                such person or establishment has corrected the 
                violation that is the basis for such suspension.
                    ``(C) Vacating of suspension.--If the Secretary 
                determines that adequate reasons do not exist to 
                continue the suspension of a registration under 
                subparagraph (A), the Secretary shall vacate such 
                suspension.
            ``(2) Cancellation of registration.--
                    ``(A) In general.--Not earlier than 10 days after 
                providing the notice under subparagraph (B), the 
                Secretary may cancel a registration if the Secretary 
                determines that--
                            ``(i) such registration was not updated in 
                        accordance with this section or contains false, 
                        incomplete, or inaccurate information; or
                            ``(ii) the fee required under section 736C 
                        for such registration has not been paid within 
                        30 days after the date due.
                    ``(B) Notice of cancellation.--Before cancelling 
                the registration of a person or establishment under 
                this section, the Secretary shall give notice to the 
                person or establishment of the Secretary's intent to 
                cancel the registration and the basis for such 
                cancellation.
                    ``(C) Timely update or correction.--If a 
                registration is adequately updated or corrected no 
                later than 7 days after notice is provided under 
                subparagraph (B) with respect to the registration, the 
                Secretary shall not cancel such registration.''.
    (e) Registration Fee.--
            (1) Establishment.--Part 2 of subchapter C of chapter VII 
        of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g et 
        seq.) is amended by adding at the end the following:

``SEC. 736C. REGISTRATION FEE.

    ``(a) In General.--In the case of any registration under section 
510 that is attributable to the manufacture, preparation, propagation, 
compounding, processing, or importing of a drug, the Secretary shall 
assess and collect an annual fee for such registration to defray the 
increase in the costs of drug safety activities.
    ``(b) Payable Date.--A fee under this section shall be payable--
            ``(1) for a facility that was not registered under section 
        510 for the preceding fiscal year, on the date of registration; 
        and
            ``(2) for any other facility--
                    ``(A) for fiscal year 2012, not later than the 
                sooner of 90 days after the date of the enactment of 
                this section or December 31, 2011; and
                    ``(B) for a subsequent fiscal year, not later than 
                December 31 of such fiscal year.
    ``(c) Fee Amounts.--
            ``(1) Total revenue amount.--
                    ``(A) Initial year.--For fiscal year 2012, fees 
                under subsection (a) shall, except as provided in 
                subsections (f) and (g), be established to generate a 
                total revenue amount that is equal to the increase in 
                the costs of drug safety activities (as estimated by 
                the Secretary) for such fiscal year.
                    ``(B) Subsequent years.--For each of fiscal years 
                2013 through 2016, fees under subsection (a) shall, 
                except as provided in subsections (f) and (g), be the 
                total revenue amount for fiscal year 2012, as adjusted 
                under subsection (d).
            ``(2) Annual fee setting.--For fiscal year 2012 and each 
        subsequent fiscal year, the Secretary shall establish 
        registration fees under subsection (a)--
                    ``(A) based on the total revenue amount applicable 
                under paragraph (1); and
                    ``(B) taking into consideration the difference in 
                costs of inspections between foreign and domestic 
                establishments.
            ``(3) Transmission to congress.--Not later than 60 days 
        before the start of fiscal year 2012 and each subsequent fiscal 
        year, the Secretary shall transmit to the Congress--
                    ``(A) the total revenue amount for the upcoming 
                fiscal year, as applicable under paragraph (1); and
                    ``(B) the registration fees for such year, as 
                established under paragraph (2).
    ``(d) Inflation Adjustment.--For fiscal year 2013 and subsequent 
fiscal years, the fee amount under subsection (c) shall be adjusted by 
the Secretary by notice, published in the Federal Register, for the 
respective fiscal year to reflect the greater of--
            ``(1) the total percentage change that occurred in the 
        Consumer Price Index for all urban consumers (all items; United 
        States city average) for the 12-month period ending June 30 
        preceding the fiscal year for which fees are being established;
            ``(2) the total percentage change for the previous fiscal 
        year in basic pay under the General Schedule in accordance with 
        section 5332 of title 5, United States Code, as adjusted by any 
        locality-based comparability payment pursuant to section 5304 
        of such title for Federal employees stationed in the District 
        of Columbia; or
            ``(3) the average annual change in the cost, per full-time 
        equivalent position of the Food and Drug Administration, of all 
        personnel compensation and benefits paid with respect to such 
        positions for the first 5 years of the preceding 6 fiscal 
        years.
The adjustment made each fiscal year under this subsection will be 
added on a compounded basis to the sum of all adjustments made each 
fiscal year after fiscal year 2011 under this subsection.
    ``(e) Fee Waiver or Reduction.--The Secretary may grant to a person 
a waiver from, or a reduction of, one or more fees under this section 
if the Secretary finds that--
            ``(1) such waiver or reduction is necessary to protect the 
        public health; or
            ``(2) the assessment of the fee would impose significant 
        financial hardship because of limited resources available to 
        such person or other circumstances.
    ``(f) Limitations.--
            ``(1) In general.--Fees under subsection (a) shall be 
        refunded for a fiscal year beginning after fiscal year 2012 
        unless appropriations for salaries and expenses of the Food and 
        Drug Administration for such fiscal year (excluding the amount 
        of fees appropriated for such fiscal year) are equal to or 
        greater than the amount of appropriations for the salaries and 
        expenses of the Food and Drug Administration for the fiscal 
        year 2012 (excluding the amount of fees appropriated for such 
        fiscal year) adjusted in the same manner that fee amounts are 
        adjusted under subsection (d).
            ``(2) Authority.--If the Secretary does not assess fees 
        under subsection (a) during any portion of a fiscal year 
        because of paragraph (1) and if at a later date in such fiscal 
        year the Secretary may assess such fees, the Secretary may 
        assess and collect such fees, without any modification in the 
        rate, for registration under section 510 at any time in such 
        fiscal year.
    ``(g) Crediting and Availability of Fees.--
            ``(1) In general.--Fees authorized under subsection (a) 
        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.
            ``(2) Collections and appropriations acts.--The fees 
        authorized by this section--
                    ``(A) shall be retained in each fiscal year in an 
                amount not to exceed the amount specified in 
                appropriations Acts, or otherwise made available for 
                obligation, for such fiscal year; and
                    ``(B) shall only be collected and available to 
                defray the costs of drug safety activities.
            ``(3) Authorization of appropriations.--For each of the 
        fiscal years 2012 through 2016, there are authorized to be 
        appropriated for fees under this section such sums as may be 
        necessary.
    ``(h) Collection of Unpaid Fees.--In any case in which the 
Secretary does not receive payment of a fee assessed under subsection 
(a) within 30 days after it is due, such fee shall be treated as a 
claim of the United States Government subject to subchapter II of 
chapter 37 of title 31, United States Code.
    ``(i) Construction.--This section may not be construed to require 
that the number of full-time equivalent positions in the Department of 
Health and Human Services, for officers, employers, and advisory 
committees not engaged in drug safety activities, be reduced to offset 
the number of officers, employees, and advisory committees so engaged.
    ``(j) Annual Fiscal Reports.--Beginning with fiscal year 2013, not 
later than 120 days after the end of each fiscal year for which fees 
are collected under this section, the Secretary shall prepare and 
submit to the Committee on Energy and Commerce of the House of 
Representatives and the Committee on Health, Education, Labor, and 
Pensions of the Senate a report on the implementation of the authority 
for such fees during such fiscal year and the use, by the Food and Drug 
Administration, of the fees collected for such fiscal year.
    ``(k) Relation to Other Fees.--Fees assessed and collected under 
this section are in addition to other fees assessed and collected under 
this Act with respect to the same person or establishment.
    ``(l) Definitions.--In this section:
            ``(1) The term `costs of drug safety activities' means the 
        expenses incurred in connection with drug safety activities 
        for--
                    ``(A) officers and employees of the Food and Drug 
                Administration, contractors of the Food and Drug 
                Administration, advisory committees, and costs related 
                to such officers, employees, and committees and to 
                contracts with such contractors;
                    ``(B) laboratory space;
                    ``(C) management of information, and the 
                acquisition, maintenance, and repair of information 
                technology resources;
                    ``(D) leasing, maintenance, renovation, and repair 
                of facilities and acquisition, maintenance, and repair 
                of fixtures, furniture, scientific equipment, and other 
                necessary materials and supplies; and
                    ``(E) collecting fees under this section and 
                accounting for resources allocated for drug safety 
                activities.
            ``(2) The term `drug safety activities' means activities 
        related to compliance by persons and establishments registered 
        under section 510 with the requirements of this Act relating to 
        drugs (including research related to and the development of 
        standards (such as performance standards and preventive 
        controls), risk assessments, hazard analyses, inspection 
        planning and inspections, third-party inspections, compliance 
        review and enforcement, import review, information technology 
        support, test development, product sampling, risk 
        communication, and administrative detention).''.
            (2) Transitional provisions.--
                    (A) First imposition of fees.--The Secretary of 
                Health and Human Services shall first impose the fee 
                established under section 736C of the Federal Food, 
                Drug, and Cosmetic Act, as added by paragraph (1), for 
                fiscal years beginning with fiscal year 2012.
                    (B) Sunset date.--Section 736C of the Federal Food, 
                Drug, and Cosmetic Act, as added by paragraph (1), does 
                not authorize the assessment or collection of a fee for 
                registration under section 510 of such Act (21 U.S.C. 
                360) occurring after fiscal year 2016.
    (f) Modification of Registration Form.--Not later than 180 days 
after the date of the enactment of this Act, the Secretary of Health 
and Human Services shall modify the registration forms under section 
510 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350d) to 
comply with the amendments made by this section.

SEC. 102. DRUG SUPPLY QUALITY AND SAFETY.

    (a) Definitions.--Section 201(g) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321(g)) is amended by adding at the end the 
following:
    ``(3) In the case of a drug, the term `component' includes--
            ``(A) any active ingredient or bulk drug substance;
            ``(B) any inactive ingredient;
            ``(C) any intermediate of an active ingredient, inactive 
        ingredient, or bulk drug substance, whether or not it appears 
        in the finished product and whether or not derived from any 
        chemical, human, animal, plant, or other material; and
            ``(D) any original source material for components specified 
        in clauses (A), (B), and (C) whether or not the original source 
        material--
                    ``(i) appears in the finished product; and
                    ``(ii) is derived from any chemical, human, animal, 
                plant, or other material.''.
    (b) Effective Quality Systems.--
            (1) Prohibited acts.--
                    (A) Recordkeeping.--Section 301(e) of the Federal 
                Food, Drug, and Cosmetic Act (21 U.S.C. 331(e)) is 
                amended--
                            (i) by inserting ``503C,'' after 
                        ``417(g),''; and
                            (ii) by inserting ``503C,'' after ``417,''.
                    (B) Adulteration.--Section 501 of the Federal Food, 
                Drug, and Cosmetic Act (21 U.S.C. 351) is amended by 
                adding at the end the following:
    ``(j) If it is a drug that was manufactured (as defined in section 
503C) by a manufacturer that is or was at the time of such manufacture 
in violation of section 503C because of the failure to have in effect 
or implement an effective quality system in accordance with such 
section.''.
            (2) System requirements.--The Federal Food, Drug, and 
        Cosmetic Act is amended by inserting after section 503B (21 
        U.S.C. 353b) the following:

``SEC. 503C. EFFECTIVE QUALITY SYSTEM FOR DRUG MANUFACTURERS.

    ``(a) In General.--Each manufacturer of a drug required to be 
registered under section 510 shall have in effect and implement an 
effective quality system.
    ``(b) System Requirements.--An effective quality system applicable 
to a manufacturer of a drug under subsection (a) shall require each of 
the following:
            ``(1) Management responsibility.--The manufacturer shall 
        ensure that--
                    ``(A) adequate resources are provided to ensure 
                compliance with current good manufacturing practice;
                    ``(B) procedures are established and maintained to 
                ensure timely communication of product quality issues 
                to appropriate levels of management, including 
                executive management;
                    ``(C) periodic reviews of process performance, 
                product quality, and other elements of the quality 
                system are conducted;
                    ``(D) the periodic reviews under subparagraph (C) 
                are evaluated by executive management to determine any 
                appropriate action; and
                    ``(E) the integrity of data, records, and 
                regulatory submissions, including with respect to 
                accuracy, veracity, and validity, is maintained.
            ``(2) Quality responsibility.--
                    ``(A) Internal, independent unit.--The manufacturer 
                shall establish and maintain an internal, independent 
                unit with the authority to ensure that all operations 
                related to manufacturing drugs, including those 
                performed by another person, are appropriately 
                designed, approved, conducted, monitored, and corrected 
                in compliance with current good manufacturing practice.
                    ``(B) Procedures.--The manufacturer shall establish 
                and maintain procedures to ensure that--
                            ``(i) any discrepancy related to 
                        manufacturing a drug (including the 
                        discrepancy's causes) is promptly identified, 
                        investigated, and corrected, the recurrence of 
                        the discrepancy is prevented, and any 
                        corrective or preventive action is verified or 
                        validated to ensure that such action is 
                        effective and does not adversely affect the 
                        drug; and
                            ``(ii) ongoing reviews of all data related 
                        to manufacturing a drug are conducted to 
                        identify trends that might affect product 
                        quality and timely actions are performed to 
                        prevent any adverse effect on product safety, 
                        identity, quality, strength, or purity.
            ``(3) Risk management.--The manufacturer shall establish 
        and maintain risk management procedures that ensure effective 
        risk assessment, control, and communication. The risk 
        assessment procedures shall ensure that all factors throughout 
        the supply chain that may reasonably be expected to indicate a 
        risk to the safety, identity, quality, strength, purity, or 
        security of any drug manufactured by that manufacturer are 
        identified, starting with factors relating to origin of all 
        components including the original source materials; information 
        relating to all such factors is continuously gathered, 
        monitored, and evaluated; and new factors are promptly 
        identified.
            ``(4) Supply chain management.--
                    ``(A) In general.--The manufacturer shall establish 
                and maintain procedures that ensure the safety, 
                identity, quality, strength, purity, and security of 
                all drugs and other materials used by that 
                manufacturer. The supply chain procedures shall address 
                the entire supply chain from original source materials 
                used in the manufacture of the drug to the 
                manufacturer. The supply chain procedures shall ensure 
                that there is adequate followup, which shall include no 
                longer receiving any source materials or drugs from, or 
                using operations conducted by, any person who fails to 
                implement timely corrections for supply chain 
                management practices or other applicable requirements 
                under this Act or sections 351 or 361 of the Public 
                Health Service Act.
                    ``(B) Procedures.--Supply chain management 
                procedures under subparagraph (A) shall include--
                            ``(i) acceptance and rejection criteria for 
                        each component that ensures that such component 
                        is appropriate for its intended use and that 
                        include, unless not feasible using current 
                        technology, a sufficient impurity profile for 
                        each component, including each component that 
                        is naturally derived, except that the 
                        requirements of this clause shall not apply to 
                        any component of a licensed biological product 
                        unless required under the license issued for 
                        such product under section 351 of the Public 
                        Health Service Act or under paragraph (5);
                            ``(ii) onsite audits, performed by 
                        qualified individuals, of each person that 
                        supplies a drug or conducts operations related 
                        to manufacturing, before such person begins 
                        initial supply or operation and at an 
                        appropriate frequency to assess the continued 
                        compliance of such person with the 
                        manufacturer's supply chain practices and with 
                        the applicable requirements under this Act and 
                        sections 351 and 361 of the Public Health 
                        Service Act;
                            ``(iii) requirements for a quality 
                        agreement with any person who supplies a drug 
                        or conducts operations related to manufacturing 
                        a drug which addresses all applicable current 
                        good manufacturing practice requirements;
                            ``(iv) the sharing of manufacturing 
                        information by any person who supplies a drug 
                        or conducts operations related to 
                        manufacturing, including timely notification 
                        concerning any change to, discrepancy in, or 
                        defect in, materials or operations related to 
                        manufacturing, along with adequate information 
                        about such change, discrepancy, or defect;
                            ``(v) when supplying any drug to another 
                        manufacturer, provision of a certificate of 
                        analysis for each batch and lot that includes 
                        complete source, manufacturing, and test 
                        information and results; and
                            ``(vi) methods, which shall include 
                        acceptance and rejection criteria, adequate--
                                    ``(I) to detect, or exclude the 
                                possibility of, the presence of any 
                                substance that may reasonably be 
                                expected to indicate a risk to safety, 
                                identity, quality, strength, purity, or 
                                security; and
                                    ``(II) to detect, or exclude the 
                                possibility of, other risks to safety, 
                                identity, quality, strength, purity, or 
                                security.
            ``(5) Methods.--
                    ``(A) In general.--Each manufacturer shall 
                establish and maintain procedures that ensure--
                            ``(i) periodic evaluation and, where 
                        necessary, prompt revision of methods, 
                        including acceptance and rejection criteria, to 
                        ensure the safety, identity, quality, strength, 
                        purity, and security of each drug manufactured 
                        by such manufacturer, or component used in the 
                        manufacture of such drug;
                            ``(ii) when any new risk is identified--
                                    ``(I) adoption of appropriate 
                                revised or new methods; and
                                    ``(II) evaluation of every batch 
                                and lot of drug using such revised 
                                methods; and
                            ``(iii) if required, an application is 
                        submitted for timely approval by the Secretary 
                        of the revised or new methods under section 
                        505, 506A, 512, or 571 of this Act or section 
                        351 of the Public Health Service Act.
                    ``(B) Determination of risk.--Each evaluation and 
                revision under subparagraph (A)(i) shall be based on a 
                determination of risk.
                    ``(C) Notification regarding revised method.--Each 
                manufacturer of a drug shall promptly notify the 
                Secretary and the appropriate body charged with 
                revision of an official compendium of any revised 
                method for such drug and its rationale. Such 
                notification shall be made in such form and manner as 
                the Secretary shall prescribe by regulation.
                    ``(D) Orders regarding revised or new methods.--If 
                the Secretary determines that a revised or new method, 
                including acceptance and rejection criteria, is 
                appropriate for the safety, identity, quality, 
                strength, purity, or security of any drug, the 
                Secretary may by letter order any manufacturer of such 
                drug to promptly--
                            ``(i) revise any method, or adopt any new 
                        method, and any related acceptance and 
                        rejection criteria for such drug; and
                            ``(ii) implement such revised or new method 
                        and any related acceptance and rejection 
                        criteria.
            ``(6) Records.--
                    ``(A) In general.--Each manufacturer shall maintain 
                adequate, contemporaneous records (which may be 
                electronic) to document conformity with requirements 
                under this section. Such records shall be accurate, 
                indelible, and legible. Each manufacturer shall 
                establish and maintain a procedure to ensure the 
                identification, storage, protection, retrieval, 
                retention, and disposition of such records.
                    ``(B) Maintenance of records; inspection.--Each 
                manufacturer shall maintain records under subparagraph 
                (A) for at least 2 years from the date of the 
                expiration date of the drug involved and make such 
                records readily available for inspection by the 
                Secretary. Such records or copies thereof shall be 
                subject to photocopying or other means of reproduction 
                as part of such inspection. Each manufacturer shall 
                provide to the Secretary these records or copies 
                thereof in a timely manner, upon verbal or written 
                request by an officer or employee duly designated by 
                the Secretary.
            ``(7) Additional provisions.--If the Secretary determines 
        that provisions in addition to those described in paragraphs 
        (1) through (6) would be appropriate to provide additional 
        assurance of the safety, identity, quality, strength, purity, 
        or security of any drug, the Secretary may promulgate such 
        provisions by regulation.
    ``(c) Exemptions and Variances.--Any person subject to any 
requirement prescribed pursuant to this section may petition the 
Secretary for an exemption or variance from such requirement. Such a 
petition shall be submitted to the Secretary in such form and manner as 
the Secretary shall prescribe by regulation. If, when granting a 
request for exemption or variance under this subsection, the Secretary 
determines that it is appropriate to apply the exemption or variance to 
more than one manufacturer, the Secretary shall publish a notice of the 
exemption or variance in the Federal Register.
    ``(d) Definitions.--In this section:
            ``(1) The term `manufacturer' means any person who 
        manufactures a drug.
            ``(2) The terms `manufacture', `manufacturing', or 
        `manufactured' include preparation, processing, packing, or 
        holding.
            ``(3) The term `establish and maintain' means adequately--
                    ``(A) define, document (by paper or 
                electronically), implement, and follow; and
                    ``(B) review and, as needed, revise on an ongoing 
                basis.''.
            (3) Application.--The requirements of section 503C of the 
        Federal Food, Drug, and Cosmetic Act, as added by paragraph 
        (2), apply beginning on the date that is 2 years after the date 
        of the enactment of this Act.
    (c) Documentation of Supply Chain.--
            (1) In general.--Section 510 of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 360j), as amended, is further amended 
        by adding at the end the following:
    ``(r) Documentation of Supply Chain.--Each establishment required 
to be registered under this section for the manufacture, preparation, 
propagation, compounding, or processing of a drug, shall maintain and 
provide to the Secretary, upon request, adequate information, in 
electronic form, establishing--
            ``(1) where the drug, including its raw materials, was 
        produced, including all preceding producers, manufacturers, 
        distributors, and shippers; and
            ``(2) that the drug, its ingredients, and its raw materials 
        were manufactured, prepared, propagated, compounded, processed, 
        distributed, shipped, warehoused, brokered, imported, and 
        conveyed under conditions that ensure the identity, strength, 
        quality, and purity of the drug.''.
            (2) Application.--The amendment made by paragraph (1) 
        applies beginning on the date that is 2 years after the date of 
        the enactment of this Act.

SEC. 103. INSPECTION OF PRODUCERS OF DRUGS.

    (a) Inspection.--Subsection (h) of section 510 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360) is amended--
            (1) by striking ``(h)'' and inserting ``(h)(1)''; and
            (2) by adding at the end the following:
    ``(2) Notwithstanding paragraph (1), every establishment engaged in 
the manufacture, propagation, compounding, or processing of a drug that 
is a finished dosage form or an active pharmaceutical ingredient shall 
be inspected pursuant to section 704 by one or more officers or 
employees duly designated by the Secretary--
            ``(A) at least once in the 2-year period beginning with the 
        date of registration of such establishment pursuant to this 
        section and at least once in every successive 2-year period 
        thereafter; or
            ``(B) at least once in the 4-year period beginning with the 
        date of registration of such establishment pursuant to this 
        section and at least once in every successive 4-year period 
        thereafter, if the Secretary determines that sufficient 
        information about the type of product produced in the 
        establishment, inspection history, compliance history, and such 
        additional factors as the Secretary determines by guidance, 
        exists to assess risk and to establish a risk-based inspection 
        schedule.
    ``(3) The Secretary shall conduct an inspection of a drug 
establishment when the establishment begins to manufacture, prepare, 
propagate, compound, or process a drug that is a finished dosage form 
or active pharmaceutical ingredient before the drug is introduced into 
interstate commerce if the active ingredient is new to the drug product 
or the drug has undergone a major change requiring prior approval by 
the Secretary of a supplement to an application submitted under section 
505. Notwithstanding the preceding sentence, the Secretary may opt 
against conducting such an inspection if the Secretary determines, 
based on the inspection history of the establishment, that such an 
inspection is not necessary to verify the data contained in the 
application (or supplement to the application) submitted under section 
505, ensure compliance with current good manufacturing practices, or 
otherwise ensure the safety of the drug or ingredient.
    ``(4) The Secretary may inspect, pursuant to section 704, every 
establishment engaged in the manufacture, propagation, compounding, or 
processing of an excipient of a drug to the same extent as the 
Secretary is authorized to inspect an establishment engaged in the 
manufacture, propagation, compounding, or processing of any other drug.
    ``(5) Nothing in this subsection shall be construed as limiting the 
authority of the Secretary to conduct inspections of establishments 
under any other provision of the Act.
    ``(6) With respect to fiscal year 2012 and each subsequent fiscal 
year, the Secretary shall submit an annual report to the Congress on--
            ``(A) funding dedicated to inspections under this 
        subsection of establishments engaged in the manufacture, 
        propagation, compounding, or processing of a drug; and
            ``(B) the number of such establishments for which the 
        frequency of such inspections has been modified pursuant to 
        paragraph (2).
    ``(7) For purposes of determining inspection frequency under 
paragraph (2), the Secretary shall establish information systems 
capacity sufficient to assess risk and shall develop and maintain a 
risk-based system for conducting surveillance of current good 
manufacturing practices by establishments engaged in the manufacture, 
propagation, compounding, or processing of a drug that is a finished 
dosage form or an active pharmaceutical ingredient. The Secretary shall 
have such capacity in place and begin implementation of such risk-based 
system not later than 3 years after the date of the enactment of the 
Drug Safety Enhancement Act of 2011. Such risk-based system shall 
include consideration of the class of the establishment's products and 
associated risks, the date the establishment was last inspected, the 
establishment's compliance and safety history, the establishment's 
shipping volume and history, and such other factors as the Secretary 
determines relevant to assessing the risk presented by the 
establishment.''.
    (b) GAO Report.--Not later than 3 years after the date of the 
enactment of this Act, the Comptroller General of the United States 
shall submit a report to the Congress on the risk-based process for 
conducting surveillance of current good manufacturing practices 
developed and implemented under section 510(h)(7) of the Federal Food, 
Drug, and Cosmetic Act, as added by subsection (a)(2) of this section.
    (c) Application.--The amendments made by this section shall apply 
to drugs introduced or delivered for introduction into interstate 
commerce on or after the date of the enactment of this Act.

SEC. 104. PROHIBITION AGAINST DELAYING, LIMITING, OR REFUSING 
              INSPECTION.

    Section 501 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
351), as amended, is further amended by adding at the end the 
following:
    ``(k) If it is a drug and it has been manufactured, processed, 
packed, or held in any factory, warehouse, or establishment and the 
owner, operator, or agent of such factory, warehouse, or establishment, 
or any agent of a governmental authority in the foreign country within 
which such factory, warehouse, or establishment is located, delays or 
limits an inspection, or refuses to permit entry or inspection, under 
section 510(h) or 704.''.

SEC. 105. CLARIFICATION OF INSPECTION AUTHORITY RELATED TO BIMO AND IRB 
              INSPECTIONS.

    (a) In General.--Section 704(a)(1) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 374(a)(1)), is amended--
            (1) by inserting after the second sentence the following: 
        ``For purposes of enforcement of this Act, officers or 
        employees duly designated by the Secretary, upon presenting 
        appropriate credentials and a written notice to the owner, 
        operator, or agent in charge, are also authorized to enter, at 
        reasonable times, any premises of a clinical investigator, 
        sponsor, monitor, contract research organization, site 
        management organization, institutional review board, or other 
        person that oversees, initiates, or conducts a clinical 
        investigation subject to section 505(i), or a postmarket study 
        or clinical trial subject to section 505(k) or 505(o).''; and
            (2) by inserting ``or any establishment associated with a 
        clinical investigation subject to section 505(i), or a 
        postmarket study or clinical trial subject to section 505(k) or 
        505(o) (including the premises of any clinical investigator, 
        sponsor, monitor, contract research organization, site 
        management organization, person that oversees or participates 
        in data acquisition, data generation, data archiving, or data 
        analysis, institutional review board, or any other person, 
        other than a subject, that participates in the conduct of a 
        clinical investigation of a drug),'' before ``inspection shall 
        extend to all things therein''.
    (b) Conforming Amendment.--Section 704(a)(2) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 374(a)(2)) is amended by striking 
``third sentence'' and inserting ``fourth sentence''.

SEC. 106. NOTIFICATION, NONDISTRIBUTION, AND RECALL OF ADULTERATED OR 
              MISBRANDED DRUG PRODUCTS.

    (a) Prohibited Acts.--Section 301 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 331) is amended by adding at the end the 
following:
    ``(uu)(1) The failure to notify the Secretary in violation of 
section 568(a).
    ``(2) The failure to comply with any order issued under section 
568.''.
    (b) Notification, Nondistribution, and Recall of Adulterated or 
Misbranded Drugs.--Subchapter E of chapter V of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360bbb et seq.) is amended by adding at the 
end the following:

``SEC. 568. NOTIFICATION, NONDISTRIBUTION, AND RECALL OF ADULTERATED OR 
              MISBRANDED DRUGS.

    ``(a) Notification, Nondistribution, and Recall of Adulterated or 
Misbranded Drugs.--
            ``(1) In general.--A person required, with respect to 
        drugs, to register under section 510, 801(r), or 801(s) that 
        has reason to believe that--
                    ``(A) a drug when introduced into or while in 
                interstate commerce, or while held for sale (regardless 
                of whether the first sale) after shipment in interstate 
                commerce, is adulterated or misbranded, and
                    ``(B) as a result, the use or consumption of, or 
                exposure to, the drug (or an ingredient or component 
                used in any such drug) may result in illness or injury 
                to humans or animals,
        shall, as soon as practicable, notify the Secretary of the 
        identity and location of the drug.
            ``(2) Manner of notification.--Notification under paragraph 
        (1) shall be made in such manner and by such means as the 
        Secretary may require by regulation.
    ``(b) Voluntary Recall.--The Secretary may request that any person 
who distributes a drug that the Secretary has reason to believe is 
adulterated, misbranded, or otherwise in violation of this Act 
voluntarily--
            ``(1) recall such drug; and
            ``(2) provide for notice, including to individuals as 
        appropriate, to persons who may be affected by the recall.
    ``(c) Order To Cease Distribution.--If the Secretary has reason to 
believe that the use or consumption of, or exposure to, a drug may 
result in illness or injury to humans or animals, the Secretary shall 
have the authority to issue an order requiring any person who 
distributes such drug to immediately cease distribution of such drug.
    ``(d) Action Following Order.--Any person who is subject to an 
order under subsection (c) shall immediately cease distribution of such 
drug and provide notification as required by such order, and may appeal 
within 24 hours of issuance of such order to the Secretary. Such appeal 
may include a request for an informal hearing and a description of any 
efforts to recall such drug undertaken voluntarily by the person, 
including after a request under subsection (b). Except as provided in 
subsection (f), an informal hearing shall be held as soon as 
practicable, but not later than 5 calendar days, or less as determined 
by the Secretary, after such an appeal is filed, unless the parties 
jointly agree to an extension. After affording an opportunity for an 
informal hearing, the Secretary shall determine whether the order 
should be amended to require a recall of such drug. If, after providing 
an opportunity for such a hearing, the Secretary determines that 
inadequate grounds exist to support the actions required by the order, 
the Secretary shall vacate the order.
    ``(e) Order To Recall.--
            ``(1) Amendment.--Except as provided under subsection (f), 
        if after providing an opportunity for an informal hearing under 
        subsection (d), the Secretary determines that the order should 
        be amended to include a recall of the drug with respect to 
        which the order was issued, the Secretary shall amend the order 
        to require a recall.
            ``(2) Contents.--An amended order under paragraph (1) 
        shall--
                    ``(A) specify a timetable in which the recall will 
                occur;
                    ``(B) require periodic reports to the Secretary 
                describing the progress of the recall; and
                    ``(C) provide for notice, including to individuals 
                as appropriate, to persons who may be affected by the 
                recall. In providing for such notice, the Secretary may 
                allow for the assistance of health professionals, State 
                or local officials, or other individuals designated by 
                the Secretary.
    ``(f) Emergency Recall Order.--
            ``(1) In general.--If the Secretary has credible evidence 
        or information that a drug subject to an order under subsection 
        (c) presents an imminent threat of serious adverse health 
        consequences or death to humans or animals, the Secretary may 
        issue an order requiring any person who distributes such drug--
                    ``(A) to immediately recall such drug; and
                    ``(B) to provide for notice, including to 
                individuals as appropriate, to persons who may be 
                affected by the recall.
            ``(2) Action following order.--Any person who is subject to 
        an emergency recall order under this subsection shall 
        immediately recall such drug and provide notification as 
        required by such order, and may appeal within 24 hours after 
        issuance such order to the Secretary. The person subject to an 
        emergency recall order shall conduct the recall notwithstanding 
        the pendency of any such appeal. An informal hearing shall be 
        held as soon as practicable but not later than 5 calendar days, 
        or less as determined by the Secretary, after such an appeal is 
        filed, unless the parties jointly agree to an extension. After 
        affording an opportunity for an informal hearing, the Secretary 
        shall determine whether the order should be amended pursuant to 
        subsection (e)(1). If, after providing an opportunity for such 
        a hearing, the Secretary determines that inadequate grounds 
        exist to support the actions required by the order, the 
        Secretary shall vacate the order.
    ``(g) Notice to Consumers and Health Officials.--The Secretary 
shall, as the Secretary determines to be necessary, provide notice of a 
recall order under this section to consumers to whom the drug was, or 
may have been, distributed and to appropriate State and local health 
officials.
    ``(h) Savings Clause.--Nothing contained in this section shall be 
construed as limiting--
            ``(1) the authority of the Secretary to issue an order to 
        cease distribution of, or to recall, a drug under any other 
        provision of this Act or the Public Health Service Act; or
            ``(2) the ability of the Secretary to request any person to 
        perform a voluntary activity related to any drug subject to 
        this Act or the Public Health Service Act.''.
    (c) Articles Subject to Refusal.--The third sentence of subsection 
(a) of section 801 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 381) is amended by inserting ``or (4) in the case of a drug, 
such article is subject to an order under section 568 to cease 
distribution of or recall the article,'' before ``then such article 
shall be refused admission''.
    (d) Application.--Sections 301(uu) and 568 of the Federal Food, 
Drug, and Cosmetic Act, as added by subsections (a) and (b), shall 
apply with respect to a drug as of such date, not later than 1 year 
after the date of the enactment of this Act, as the Secretary of Health 
and Human Services shall specify.

SEC. 107. NOTIFICATION.

    (a) In General.--
            (1) Prohibited acts.--Section 301 of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 331), as amended, is further 
        amended by adding at the end the following:
    ``(vv) The failure to notify the Secretary in violation of section 
569.''.
            (2) Notification.--Subchapter E of chapter V of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb et seq.), as 
        amended, is further amended by adding at the end the following:

``SEC. 569. NOTIFICATION.

    ``(a) Notification to Secretary.--With respect to a drug, the 
Secretary may require notification to the Secretary by a regulated 
person of--
            ``(1) the use of, or exposure to, such drug which may 
        result in illness or injury to humans or animals;
            ``(2) a significant loss or known theft of such drug;
            ``(3) a reasonable probability that such drug has been or 
        is being counterfeited;
            ``(4) repeated failures by a manufacturer of a component or 
        other material used in the manufacture of such drug to ensure 
        compliance with applicable quality systems requirements under 
        section 501(a)(2)(B) or 503C of this Act or section 351 or 361 
        of the Public Health Service Act;
            ``(5) any incident causing such drug to be mistaken for, or 
        its labeling applied to, another drug;
            ``(6) any contamination or any significant chemical, 
        physical, or other change or deterioration in such drug after 
        distribution, or any failure of a distributed lot or batch of 
        such drug to meet an established specification; and
            ``(7) any other type of information regarding such drug 
        that the Secretary deems necessary for protection of the public 
        health.
    ``(b) Manner of Notification.--Notification under this section 
shall be made in such manner and by such means as the Secretary may 
require by regulation or guidance.
    ``(c) Definition.--In this section, the term `regulated person' 
means a person who is required to register under section 510, 801(r), 
or 801(s); a wholesale distributor of a drug product; and any other 
person that distributes drugs except exclusively for retail sale.''.
    (b) Exchange of Information.--
            (1) Prohibited acts.--
                    (A) In general.--The first sentence of section 
                301(j) of the Federal Food, Drug, and Cosmetic Act (21 
                U.S.C. 331(j)) is amended--
                            (i) by striking ``or'' before ``to the 
                        courts when relevant''; and
                            (ii) by inserting ``, or as specified in 
                        section 708,'' before ``any information 
                        acquired''.
                    (B) Technical corrections.--The first sentence of 
                such section 301(j) is further amended--
                            (i) by striking ``573.'' and inserting 
                        ``573''; and
                            (ii) by striking the second of the two 
                        consecutive periods at the end.
            (2) Amendment.--Section 708 of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 379) is amended--
                    (A) by striking ``The Secretary'' and inserting 
                ``(a) The Secretary''; and
                    (B) by adding at the end the following:
    ``(b)(1)(A) The Secretary may provide to any Federal agency acting 
within the scope of its jurisdiction any information respecting a drug 
that is exempt from disclosure pursuant to subsection (a) of section 
552 of title 5, United States Code, by reason of subsection (b)(4) of 
such section.
    ``(B) Any such information provided to another Federal agency shall 
not be disclosed by such agency except in any investigation within the 
receiving agency's jurisdiction or in an action or proceeding under the 
laws of the United States in which the receiving agency or the United 
States is a party.
    ``(2)(A) In carrying out this Act, the Secretary may provide to a 
State or local government agency any information respecting a drug that 
is exempt from disclosure pursuant to section 552(a) of title 5, United 
States Code, by reason of subsection (b)(4) of such section.
    ``(B) Any such information provided to a State or local government 
agency shall not be disclosed by such agency.
    ``(3) Except as provided by section 301(j), in carrying out this 
Act, the Secretary may provide to any person any information respecting 
a drug that is exempt from disclosure pursuant to section 552(a) of 
title 5, United States Code, by reason of subsection (b)(4) of such 
section, if the Secretary determines that providing the information to 
the person is appropriate under the circumstances and the recipient 
provides adequate assurances to the Secretary that the recipient will 
preserve the confidentiality of the information.
    ``(4) In carrying out this Act, the Secretary may provide any 
information respecting a drug that is exempt from disclosure pursuant 
to section 552(a) of title 5, United States Code, by reason of 
subsection (b)(4) of such section--
            ``(A) to any foreign government agency; or
            ``(B) any international organization established by law, 
        treaty, or other governmental action and having 
        responsibility--
                    ``(i) to facilitate global or regional 
                harmonization of standards and requirements in an area 
                of responsibility of the Food and Drug Administration; 
                or
                    ``(ii) to promote and coordinate public health 
                efforts, if the agency or organization provides 
                adequate assurances to the Secretary that the agency or 
                organization will preserve the confidentiality of the 
                information.
    ``(c) Except as provided by section 301(j), the Secretary may 
disclose to the public any information respecting a drug that is exempt 
from disclosure pursuant to section 552(a) of title 5, United States 
Code, by reason of subsection (b)(4) of such section, if the Secretary 
determines that such disclosure is necessary to protect the public 
health.
    ``(d) Except as provided in subsection (e), the Secretary shall not 
be required to disclose under section 552 of title 5, United States 
Code, or any other provision of law any information respecting a drug 
obtained from a Federal, State, or local government agency, or from a 
foreign government agency, or from an international organization 
described in subsection (b)(4), if the agency or organization has 
requested that the information be kept confidential, or has precluded 
such disclosure under other use limitations, as a condition of 
providing the information.
    ``(e) Nothing in subsection (d) authorizes the Secretary to 
withhold information from the Congress or prevents the Secretary from 
complying with an order of a court of the United States.
    ``(f) This section shall not affect the authority of the Secretary 
to provide or disclose information under any other provision of law.''.

                           TITLE II--RESPONSE

SEC. 201. ADMINISTRATIVE DETENTION.

    (a) Administrative Detention of Drugs.--Section 304 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 334) is amended by adding at 
the end the following:
    ``(i) Administrative Detention of Drugs.--
            ``(1) Detention authority.--
                    ``(A) In general.--If during any lawful activity 
                conducted by an officer or employee, a drug which such 
                officer or employee has reason to believe is in 
                violation of any provision of this Act is found, such 
                officer or employee may order the drug detained (in 
                accordance with regulations prescribed by the 
                Secretary) for a reasonable period which may not exceed 
                20 days unless the Secretary determines that a period 
                of detention greater than 20 days is required to 
                institute an action under subsection (a) or section 
                302, in which case the Secretary may authorize a 
                detention period of not to exceed 60 days.
                    ``(B) Secretary's approval.--Regulations of the 
                Secretary prescribed under this paragraph shall require 
                that, before a drug may be ordered detained under this 
                paragraph, the Secretary or an officer or employee 
                designated by the Secretary approve such order.
                    ``(C) Security of detained drug.--A detention order 
                under this paragraph may require--
                            ``(i) the labeling or marking of a drug 
                        during the period of its detention for the 
                        purpose of identifying the drug as detained; 
                        and
                            ``(ii) that the drug be removed to a secure 
                        facility, as appropriate.
                    ``(D) Appeal of detention order.--
                            ``(i) Right to appeal.--Any person who 
                        would be entitled to claim a drug if it were 
                        seized under subsection (a) may appeal to the 
                        Secretary a detention of such drug under this 
                        paragraph.
                            ``(ii) Hearing and response.--Within 15 
                        days of the date an appeal of a detention is 
                        filed with the Secretary, the Secretary shall 
                        after affording opportunity for an informal 
                        hearing by order confirm the detention or 
                        revoke it.
            ``(2) Limitation on movement of detained drugs.--
                    ``(A) In general.--Except as authorized by 
                subparagraph (B), a drug subject to a detention order 
                issued under paragraph (1) shall not be moved by any 
                person from the place at which it is ordered detained 
                until--
                            ``(i) released by the Secretary; or
                            ``(ii) the expiration of the detention 
                        period applicable to such order,
                whichever occurs first.
                    ``(B) Exception.--A drug subject to a detention 
                order under paragraph (1) may be moved--
                            ``(i) in accordance with regulations 
                        prescribed by the Secretary; and
                            ``(ii) if not in final form for shipment, 
                        at the discretion of the manufacturer of the 
                        device for the purpose of completing the work 
                        required to put it in such form.''.
    (b) Regulations.--The Secretary shall issue regulations or guidance 
to implement the amendments made by this section.
    (c) Prohibited Acts.--Section 301(r) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 331), is amended--
            (1) by inserting ``, drug,'' after ``device'', each place 
        it appears; and
            (2) by inserting ``or section 304(i)'' after ``section 
        304(g)''.
    (d) Effective Date.--The amendments made by this section shall 
apply beginning on the day that is 180 days after the date of enactment 
of this Act.

SEC. 202. DESTRUCTION OF ADULTERATED, MISBRANDED, OR COUNTERFEIT DRUGS 
              OFFERED FOR IMPORT.

    (a) In General.--Section 801 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 381) is amended by adding at the end the 
following:
    ``(q)(1) Subject to paragraph (2), the Secretary of the Treasury 
shall cause the destruction, upon referral from the Secretary of Health 
and Human Services, of any drug that--
            ``(A) poses a reasonable probability of causing a 
        significant adverse health effect, as determined by the 
        Secretary of Health and Human Services; or
            ``(B) is valued at an amount that is $2,000 or less (or 
        such higher amount as the Secretary of the Treasury may set by 
        regulation pursuant to section 498 of the Tariff Act of 1930).
    ``(2) The Secretary of Health and Human Services shall issue 
regulations providing for notice and an opportunity for an informal 
hearing for destruction of drugs under paragraph (1). The regulations 
under this paragraph shall allow the Secretary of Health and Human 
Services to provide the notice and opportunity for an informal hearing 
to the owner or consignee after the destruction has occurred.
    ``(3) For a drug not described in paragraph (1), the Secretary of 
Health and Human Services shall provide for notice and an opportunity 
for an informal hearing to the owner or consignee before the 
destruction of the drug under the fifth sentence of subsection (a).''.
    (b) Conforming Amendment.--The fifth sentence of subsection (a) of 
section 801 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381) 
is amended by striking ``The Secretary of the Treasury shall'' and 
inserting ``Except as provided in subsection (q), the Secretary of the 
Treasury shall''.
    (c) Application.--The amendments made by subsections (a) and (b) 
shall apply beginning on the day that is 90 days after the date of the 
enactment of this Act.

SEC. 203. CRIMINAL PENALTIES.

    Section 303 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
333) is amended--
            (1) in subsection (a)--
                    (A) in paragraph (1), by striking ``Any'' and 
                inserting ``Except as provided in paragraph (2) or (3), 
                any''; and
                    (B) by adding at the end the following:
    ``(3) Notwithstanding paragraph (1), any person who, with respect 
to a drug, knowingly violates paragraph (a), (b), (c), (d), (f), (g), 
(i), (k), or (jj)(3) of section 301 shall be imprisoned for not more 
than 10 years or fined in accordance with title 18, United States Code, 
or both.''; and
            (2) in subsection (b)(1), by striking ``fined not more than 
        $250,000'' and inserting ``fined in accordance with title 18, 
        United States Code''.

SEC. 204. CIVIL PENALTIES.

    (a) In General.--Section 303(f) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 331(f)) is amended by striking paragraph (4) 
and inserting the following:
            ``(4)(A) Except as provided in paragraph (3) and subsection 
        (g), any person who violates a requirement of this Act that 
        relates to drugs shall be subject to a civil penalty in an 
        amount not to exceed--
                    ``(i) $500,000 for each such violation; and
                    ``(ii) for all such violations adjudicated in a 
                single proceeding, $10,000,000.
            ``(B) Each violation described in subparagraph (A) and each 
        day during which the violation continues shall be considered to 
        be a separate offense.''.
    (b) Conforming Amendments.--
            (1) Section 303(f)(3) of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 331(f)(3)) is amended--
                    (A) in subparagraph (A), by striking ``Any person 
                who'' and inserting ``Notwithstanding paragraph (4), 
                any person who''; and
                    (B) in subparagraph (B), by striking ``If a 
                violation of'' and inserting ``Notwithstanding 
                paragraph (4), if a violation of''.
            (2) Section 303(g)(1) of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 331(g)(1)) is amended by striking 
        ``With respect to a person who'' and inserting 
        ``Notwithstanding subsection (f)(4), with respect to a person 
        who''.

SEC. 205. SEIZURE.

    Section 304(b) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 334(b)) is amended--
            (1) by striking ``(b)'' and inserting ``(b)(1)''; and
            (2) by adding at the end the following:
    ``(2) Procedure With Respect to Drugs; Multiplicity of Pending 
Proceedings.--In the case of a violation relating to a drug, the 
article, equipment, or other thing proceeded against shall be liable to 
seizure by process pursuant to the libel, and the procedure in cases 
under this section shall conform, as nearly as may be, to the procedure 
in admiralty rather than the procedure used for civil asset forfeiture 
proceedings set forth in section 983 of title 18, United States Code. 
On demand of either party, any issue of fact joined in any such case 
brought under this section shall be tried by jury. Any such seizure 
brought under this section is not governed by Rule G of the 
Supplemental Rules of Admiralty or Maritime Claims and Asset Forfeiture 
Actions. In addition, exigent circumstances shall be deemed to exist 
for all such seizures brought under this section, and in such cases, 
the summons and arrest warrant shall be issued by the clerk of the 
court without court review. When libel for condemnation proceedings 
relating to a drug under this section, involving the same claimant and 
the same issues of adulteration or misbranding, are pending in two or 
more jurisdictions, such pending proceedings, upon application of the 
claimant reasonably made to the court of one such jurisdiction, shall 
be consolidated for trial by order of such court, and tried in (1) any 
district selected by the claimant where one of such proceedings is 
pending; or (2) a district agreed upon by stipulation between the 
parties. If no order for consolidation is so made within a reasonable 
time, the claimant may apply to the court of one such jurisdiction, and 
such court (after giving the United States attorney for such district 
reasonable notice and opportunity to be heard) shall by order, unless 
good cause to the contrary is shown, specify a district of reasonable 
proximity to the claimant's principal place of business, in which all 
such pending proceedings shall be consolidated for trial and tried. 
Such order of consolidation shall not apply so as to require the 
removal of any case the date for trial of which has been fixed. The 
court granting such order shall give prompt notification thereof to the 
other courts having jurisdiction of the cases covered thereby.''.

SEC. 206. ASSET FORFEITURE.

    (a) In General.--Section 303 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 333) is amended by adding at the end the 
following:
    ``(h) Forfeiture Related to Violations With Respect to Drugs.--
            ``(1) Criminal forfeiture.--Any person convicted of a 
        violation of section 301 with respect to drugs, or a conspiracy 
        to commit such violation, shall forfeit to the United States 
        any property, real or personal, constituting or traceable to 
        the gross proceeds obtained, directly or indirectly, as a 
        result of such violation. Pursuant to section 2461(c) of title 
        28, United States Code, the provisions of section 413 of the 
        Controlled Substances Act, except subsections (a), (d), and (q) 
        of such section 413, shall apply to criminal forfeitures under 
        this paragraph.
            ``(2) Civil forfeiture.--Any property, real or personal, 
        constituting or traceable to the gross proceeds obtained, 
        directly or indirectly, as a result of a violation of section 
        301 with respect to drugs, or a conspiracy to commit such 
        violation, is subject to forfeiture to the United States in 
        accordance with the provisions of chapter 46 of title 18, 
        United States Code, except that such duties as are imposed upon 
        the customs officer or any other person with respect to the 
        seizure and forfeiture of property under the customs laws as 
        described in section 981(d) of title 18, United States Code, 
        shall be performed with respect to seizures and forfeitures of 
        property under this section by such officers, agents, or other 
        persons as may be authorized or designated for that purpose by 
        the Secretary.''.
    (b) Civil Forfeiture Statute Definition.--Subparagraph (C) of 
section 983(i)(2) of title 18, United States Code, is amended to read 
as follows:
                    ``(C) section 304 of the Federal Food, Drug, and 
                Cosmetic Act;''.

                 TITLE III--IMPORTATION AND EXPORTATION

SEC. 301. DOCUMENTATION FOR ADMISSIBILITY OF IMPORTS.

    (a) Prohibition.--Section 301 of the Federal, Food, Drug, and 
Cosmetic Act (21 U.S.C. 331), as amended, is further amended by adding 
at the end the following:
    ``(ww) The submission (with respect to drugs) of information that 
is required pursuant to section 801 that is inaccurate or incomplete.
    ``(xx) The failure (with respect to drugs) to submit information 
that is required pursuant to section 801.''.
    (b) Documentation for Imports.--Section 801 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 381), as amended, is further amended 
by adding at the end the following:
    ``(r) Documentation.--
            ``(1) Submission.--The Secretary may require by regulation 
        the submission of documentation or other information for a drug 
        that is imported or offered for import into the United States. 
        When developing any regulation in accordance with this 
        paragraph, to the extent that the collection of documentation 
        or other information involves Customs and Border Protection 
        efforts or resources, the Secretary shall consult with Customs 
        and Border Protection.
            ``(2) Format.--A regulation under paragraph (1) may specify 
        the format for submission of the documentation or other 
        information.
            ``(3) Refusal of admission.--A drug imported or offered for 
        import into the United States shall be refused admission unless 
        all documentation and information the Secretary requires under 
        this Act or the Public Health Service Act for such article is 
        submitted.''.

SEC. 302. REGISTRATION FOR COMMERCIAL IMPORTERS; FEE.

    (a) Registration.--
            (1) Prohibitions.--Section 301 of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 331), as amended, is further 
        amended by adding at the end the following:
    ``(yy) The failure to register in accordance with section 
801(s).''.
            (2) Misbranding.--Section 502(o) of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 352(o)), as amended, is further 
        amended by inserting ``if it is imported or offered for import 
        by an importer not duly registered under section 801(s),'' 
        before ``or if it does not bear''.
            (3) Registration.--Section 801 of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 381) is amended by adding at the 
        end the following:
    ``(s) Registration of Importers.--
            ``(1) Registration.--The Secretary shall require an 
        importer of drugs--
                    ``(A) to be registered with the Secretary in a form 
                and manner specified by the Secretary; and
                    ``(B) consistent with section 1012, to submit 
                appropriate unique identifiers as a condition of 
                registration.
            ``(2) Good importer practices.--The maintenance of 
        registration under this subsection is conditioned on compliance 
        with good importer practices in accordance with the following:
                    ``(A) The Secretary, in consultation with Customs 
                and Border Protection, shall promulgate regulations to 
                establish good importer practices that specify the 
                measures an importer shall take to ensure imported 
                drugs are in compliance with the requirements of this 
                Act and the Public Health Service Act.
                    ``(B) The measures under subparagraph (A) shall 
                ensure that the importer--
                            ``(i) has adequate information about the 
                        article, its hazards, and the requirements of 
                        this Act and the Public Health Service Act 
                        applicable to such article;
                            ``(ii) has adequate information or 
                        procedures in place to verify that both the 
                        article and each person that produced, 
                        manufactured, processed, packed, transported, 
                        or held the article, including components of 
                        the article, are in compliance with the 
                        requirements of this Act and the Public Health 
                        Service Act; and
                            ``(iii) has adequate procedures in place to 
                        take corrective action, such as the ability to 
                        appropriately trace, withhold, and recall 
                        articles, if an article imported by the 
                        importer is not in compliance with the 
                        requirements of this Act or the Public Health 
                        Service Act.
                    ``(C) In promulgating good importer practice 
                regulations under this subsection, the Secretary may, 
                as appropriate, take into account differences among 
                importers and the types of imports, including based on 
                the level of risk posed by the imported drug.
            ``(3) Suspension of registration.--
                    ``(A) In general.--Registration under this 
                subsection is subject to suspension upon a finding by 
                the Secretary, after notice and an opportunity for an 
                informal hearing, of--
                            ``(i) a violation of this Act; or
                            ``(ii) the knowing or repeated making of an 
                        inaccurate or incomplete statement or 
                        submission of information relating to the 
                        importation of a drug.
                    ``(B) Request.--The importer whose registration is 
                suspended may request that the Secretary vacate the 
                suspension of registration when such importer has 
                corrected the violation that is the basis for such 
                suspension.
                    ``(C) Vacating of suspension.--If the Secretary 
                determines that adequate reasons do not exist to 
                continue the suspension of a registration, the 
                Secretary shall vacate such suspension.
            ``(4) Cancellation of registration.--
                    ``(A) In general.--Not earlier than 10 days after 
                providing the notice under subparagraph (B), the 
                Secretary may cancel a registration if the Secretary 
                determines that--
                            ``(i) such registration was not updated in 
                        accordance with this section or otherwise 
                        contains false, incomplete, or inaccurate 
                        information; or
                            ``(ii) the registration fee required under 
                        section 743 for such registration has not been 
                        paid within 30 days after the date due.
                    ``(B) Notice of cancellation.--Cancellation shall 
                be preceded by notice to the importer of the intent to 
                cancel the registration and the basis for such 
                cancellation.
                    ``(C) Timely update or correction.--If the 
                registration for the importer is updated or corrected 
                no later than 7 days after notice is provided under 
                subparagraph (B), the Secretary shall not cancel such 
                registration.
            ``(5) Exemptions.--The Secretary, by notice in the Federal 
        Register--
                    ``(A) shall establish an exemption from the 
                requirements of this subsection for importations for 
                personal use; and
                    ``(B) may establish other exemptions from the 
                requirements of this subsection.''.
            (4) Regulations.--Not later than 36 months after the date 
        of the enactment of this Act, the Secretary of Health and Human 
        Services in consultation with the Commissioner responsible for 
        Customs and Border Protection shall promulgate the regulations 
        required to carry out section 801(s) of the Federal Food, Drug, 
        and Cosmetic Act, as added by paragraph (3). In establishing 
        the effective date of a regulation promulgated under section 
        801(s), the Secretary shall, in consultation with the 
        Commissioner responsible for Customs and Border Protection, as 
        appropriate, provide a reasonable period of time for an 
        importer of a drug to comply with good importer practices, 
        taking into account differences among importers and the types 
        of imports, including based on the level of risk posed by the 
        imported product.
            (5) Effective date.--The amendments made by this subsection 
        shall take effect on the date that is 24 months after the date 
        of enactment of this Act.
    (b) Fee.--Subchapter C of chapter VII of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 379f et seq.) is amended by adding at the 
end the following:

                      ``PART 6--IMPORTERS OF DRUGS

``SEC. 743. IMPORTERS OF DRUGS.

    ``(a) Importers.--The Secretary shall assess and collect an annual 
fee for the registration of an importer under section 801(s).
    ``(b) Amount of Fee.--
            ``(1) Base amounts.--The registration fee under subsection 
        (a) shall be--
                    ``(A) for fiscal year 2012, $500; and
                    ``(B) for fiscal year 2013 and each subsequent 
                fiscal year, the fee for fiscal year 2012 as adjusted 
                under paragraph (2).
            ``(2) Adjustment.--For fiscal year 2013 and subsequent 
        fiscal years, the fees established pursuant to paragraph (1) 
        shall be adjusted by the Secretary by notice, published in the 
        Federal Register, for a fiscal year to reflect the greater of--
                    ``(A) the total percentage change that occurred in 
                the Consumer Price Index for all urban consumers (all 
                items; United States city average) for the 12-month 
                period ending June 30 preceding the fiscal year for 
                which fees are being established;
                    ``(B) the total percentage change for the previous 
                fiscal year in basic pay under the General Schedule in 
                accordance with section 5332 of title 5, United States 
                Code, as adjusted by any locality-based comparability 
                payment pursuant to section 5304 of such title for 
                Federal employees stationed in the District of 
                Columbia; or
                    ``(C) the average annual change in the cost, per 
                full-time equivalent position of the Food and Drug 
                Administration, of all personnel compensation and 
                benefits paid with respect to such positions for the 
                first 5 years of the preceding 6 fiscal years.
            ``(3) Compounded basis.--The adjustment made each fiscal 
        year pursuant to this subsection shall be added on a compounded 
        basis to the sum of all adjustments made each fiscal year after 
        fiscal year 2012 under this subsection.
            ``(4) Waiver for importers required to pay registration 
        fee.--The Secretary shall waive the fee applicable to a person 
        under this section if such person is required to pay both--
                    ``(A) a fee under section 736C for registration of 
                one or more establishments under section 510, for 
                drugs; and
                    ``(B) a fee under this section for registration as 
                an importer under section 801(s).
    ``(c) Crediting and Availability of Fees.--
            ``(1) In general.--Fees authorized under subsection (a) 
        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.
            ``(2) Collections and appropriations acts.--The fees 
        authorized by this section--
                    ``(A) shall be retained in each fiscal year in an 
                amount not to exceed the amount specified in 
                appropriations Acts, or otherwise made available for 
                obligation, for such fiscal year; and
                    ``(B) shall only be collected and available to 
                cover the costs associated with registering importers 
                under sections 801(s) and with ensuring compliance with 
                good importer practices.
            ``(3) Authorization of appropriations.--For each of fiscal 
        years 2012 through 2016, there are authorized to be 
        appropriated for fees under this section such sums as may be 
        necessary.''.
    (c) Inspection.--Section 704 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 374) is amended by adding at the end the 
following:
    ``(h) Importers.--Every person engaged in the importing of any drug 
shall, upon request of an officer or employee designated by the 
Secretary, permit such officer or employee at all reasonable times to 
inspect the facilities of such person and have access to, and to copy 
and verify, any related records.''.

SEC. 303. REGISTRATION FOR CUSTOMS BROKERS.

    (a) Registration.--
            (1) Prohibitions.--Section 301(yy) of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 331), as added by section 
        302(a)(1), is amended by inserting ``or 801(t)'' after 
        ``801(s)''.
            (2) Misbranding.--Section 502(o) (21 U.S.C. 352(o)), as 
        amended by section 302(a)(2), is amended--
                    (A) by inserting ``or a customs broker'' after ``by 
                an importer''; and
                    (B) by inserting ``or 801(t)'' after ``801(s)''.
            (3) Registration.--Section 801 of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 381), as amended, is further 
        amended by adding at the end the following:
    ``(t) Registration of Customs Broker.--
            ``(1) Registration.--The Secretary shall require a customs 
        broker, with respect to the importation of drugs--
                    ``(A) to be registered with the Secretary in a form 
                and manner specified by the Secretary; and
                    ``(B) consistent with section 1012, to submit 
                appropriate unique identifiers as a condition of 
                registration.
            ``(2) Cancellation of registration.--
                    ``(A) In general.--Not earlier than 10 days after 
                providing the notice under subparagraph (B), the 
                Secretary may cancel a registration that the Secretary 
                determines was not updated in accordance with this 
                section or other wise contains false, incomplete, or 
                inaccurate information.
                    ``(B) Notice of cancellation.--Cancellation shall 
                be preceded by notice to the customs broker of the 
                intent to cancel the registration and the basis for 
                such cancellation.
                    ``(C) Timely update or correction.--If the 
                registration for the customs broker is updated or 
                corrected no later than 7 days after notice is provided 
                under subparagraph (B), the Secretary shall not cancel 
                such registration.
            ``(3) Notification.--The Secretary shall notify the 
        Commissioner responsible for Customs and Border Protection 
        whenever the Secretary cancels a registration under this 
        subsection.
            ``(4) Exemptions.--In consultation with the Commissioner 
        responsible for Customs and Border Protection, the Secretary, 
        by notice published in the Federal Register--
                    ``(A) shall establish an exemption from the 
                requirements of this subsection for importations for 
                personal use; and
                    ``(B) may establish other exemptions from the 
                requirements of this subsection.
            ``(5) Civil penalties.--Notwithstanding any other provision 
        in this Act, a customs broker who violates section 301 because 
        of a violation of subsection (ww), (xx), or (yy) of such 
        section shall not be subject to a civil penalty under section 
        303(f)(1)(C) of this Act.''.
            (4) Regulations.--Not later than 24 months after the date 
        of the enactment of this Act, the Secretary of Health and Human 
        Services, in consultation with the Commissioner responsible for 
        Customs and Border Protection, shall promulgate the regulations 
        required to carry out section 801(t) of the Federal Food, Drug, 
        and Cosmetic Act, as added by paragraph (3).
            (5) Effective date.--The amendments made by this subsection 
        shall take effect on the date that is 24 months after the date 
        of enactment of this Act.
    (b) Inspection.--Section 704 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 374), as amended, is further amended by adding 
at the end the following:
    ``(i) Brokers.--Every customs broker required to be registered with 
the Secretary shall, upon request of an officer or employee designated 
by the Secretary, permit such officer or employee at all reasonable 
times to inspect the facilities of such person and have access to, and 
to copy and verify, any related records.''.

SEC. 304. EXPORTATION CERTIFICATE PROGRAM.

    Section 801(e)(4) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 381(e)(4)) is amended--
            (1) in subparagraph (B), by striking ``If the Secretary'' 
        and inserting ``With respect to a device, if the Secretary''; 
        and
            (2) by adding at the end the following:
            ``(C) With respect to a drug:
                    ``(i) A certification by the Secretary under 
                subparagraph (A) need not be in writing.
                    ``(ii) Subparagraph (A) applies only with respect 
                to exportation from the United States.
                    ``(iii) Any person who exports from a country other 
                than the United States a drug approved in the United 
                States may request that the Secretary certify that the 
                exported drug meets the applicable requirements of this 
                Act. The Secretary shall issue such a certification 
                within 20 days of the receipt of a request for such 
                certification if the request demonstrates that the drug 
                meets the applicable requirements of this Act.
                    ``(iv) For purposes of this subparagraph, a 
                certification by the Secretary shall be made on such 
                basis and in such form (such as a publicly available 
                listing) as the Secretary determines appropriate.
                    ``(v) If the Secretary, with respect to a drug, 
                issues an export certification within the 20 days 
                prescribed by subparagraph (A) or clause (iii) of this 
                subparagraph, a fee for such certification may be 
                charged but such fee shall not exceed such amount as 
                the Secretary determines is reasonably related to the 
                cost of issuing such certificates. The Secretary may 
                adjust this fee annually to account for inflation and 
                other cost adjustments. Fees collected for a fiscal 
                year pursuant to this subparagraph shall be credited to 
                the appropriation account for salaries and expenses of 
                the Food and Drug Administration and shall be available 
                in accordance with appropriations Acts until expended, 
                without fiscal year limitation. Such fees shall be 
                collected in each fiscal year in an amount equal to the 
                amount specified in appropriations Acts for such fiscal 
                year and shall only be collected and available for the 
                costs of the Food and Drug Administration to cover the 
                cost of issuing such certifications. Such sums as 
                necessary may be transferred from such appropriation 
                account for salaries and expenses of the Food and Drug 
                Administration without fiscal year limitation to such 
                appropriation account for salaries and expenses with 
                fiscal year limitation.''.

SEC. 305. EXTRATERRITORIAL JURISDICTION.

    (a) In General.--Chapter III of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 331 et seq.) is amended by adding at the end 
the following:

``SEC. 311. EXTRATERRITORIAL JURISDICTION.

    ``There is extraterritorial jurisdiction over any violation of this 
Act relating to any drug if such drug was intended for import into the 
United States or if any act in furtherance of the violation was 
committed in the United States.''.
    (b) Prohibition.--Section 301 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 331), as amended, is further amended by adding 
at the end the following:
    ``(zz) The production, manufacture, processing, preparation, 
packing, holding, or distribution of an adulterated or misbranded drug 
with the knowledge or intent that such drug will be imported into the 
United States, or the production, manufacture, processing, preparation, 
packing, holding, or distribution of a drug with the knowledge or 
intent that the drug will be imported into the United States in 
violation of section 505.''.

SEC. 306. DEDICATED FOREIGN INSPECTORATE.

    Section 704 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
374), as amended, is further amended by adding at the end the 
following:
    ``(j) The Secretary shall establish and maintain a corps of 
inspectors dedicated to inspections of foreign drug facilities and 
establishments. This corps shall be staffed and funded by the Secretary 
at a level sufficient to allow it to conduct inspections of foreign 
drug facilities and establishments at a frequency at least equivalent 
to the inspection rate of domestic drug facilities and 
establishments.''.

                        TITLE IV--MISCELLANEOUS

SEC. 401. UNIQUE IDENTIFICATION NUMBER FOR ESTABLISHMENTS, IMPORTERS, 
              AND CUSTOMS BROKERS.

    Chapter X of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
391 et seq.) is amended by adding at the end the following:

``SEC. 1012. UNIQUE IDENTIFIER.

    ``(a) Registration of Establishments.--A person required to 
register a drug establishment pursuant to section 510 shall submit, at 
the time of registration, a unique identifier for the establishment.
    ``(b) Registration of Importers and Customs Brokers.--A person 
required to register pursuant to section 801(s) or 801(t) shall submit, 
at the time of registration, a unique identifier for the principal 
place of business for which such person is required to register under 
section 801(s) or 801(t).
    ``(c) Guidance.--The Secretary may, by guidance, and, with respect 
to importers and customs brokers, in consultation with the Commissioner 
responsible for Customs and Border Protection, specify the unique 
numerical identifier system to be used to meet the requirements of 
subsections (a) and (b) and the form, manner, and timing of a 
submission under such subsections. Development of such guidance shall 
take into account the utilization of existing unique identification 
schemes and compatibility with customs automated systems.
    ``(d) Importation.--A drug imported or offered for import shall be 
refused admission unless the appropriate unique identifiers, as 
specified by the Secretary, are provided for such article.''.

SEC. 402. COUNTRY OF ORIGIN LABELING.

    (a) Misbranding.--Section 502 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 352) is amended by adding at the end the 
following:
    ``(aa) If it is a finished dosage form drug and the Web site of the 
manufacturer of such drug does not list--
            ``(1) the country of origin for each active pharmaceutical 
        ingredient; and
            ``(2) the place of manufacture of the finished dosage form 
        of such drug.''.
    (b) Regulations.--Not later than 3 years after the date of the 
enactment of this Act, the Secretary shall promulgate final regulations 
to carry out section 502(aa) of the Federal Food, Drug, and Cosmetic 
Act, as added by subsection (a).
    (c) Effective Date.--The requirement of section 502(aa) of the 
Federal Food, Drug, and Cosmetic Act, as added by subsection (a), takes 
effect 4 years after the date of the enactment of this Act.

SEC. 403. FALSE OR MISLEADING REPORTING TO FDA.

    (a) In General.--Section 301(q)(2) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 331(q)(2)) is amended by inserting ``, drug,'' 
after ``device''.
    (b) Effective Date.--The amendment made by subsection (a) shall 
apply to submissions made on or after the date of the enactment of this 
Act.

SEC. 404. SUBPOENA AUTHORITY.

    (a) Prohibited Act.--Section 301(f) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 331(f)) is amended by inserting before the 
period ``or the failure or refusal to obey a subpoena issued pursuant 
to section 312''.
    (b) Exercise of Subpoena Authority.--Chapter III of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 331 et seq.), as amended, is 
further amended by adding at the end the following new section:

``SEC. 312. EXERCISE OF SUBPOENA AUTHORITY.

    ``(a) In General.--For the purpose of--
            ``(1) any hearing, investigation, or other proceeding 
        respecting a violation of a provision of this Act, the Public 
        Health Service Act, or the Federal Anti-Tampering Act, relating 
        to a drug; or
            ``(2) any hearing, investigation, or other proceeding to 
        determine if a person is in violation of a specific provision 
        of this Act, the Public Health Service Act, or the Federal 
        Anti-Tampering Act, relating to a drug,
the Commissioner may issue subpoenas requiring the attendance and 
testimony of witnesses and the production of records and other things.
    ``(b) Timing of Compliance.--When the Commissioner deems that 
immediate compliance with a subpoena issued under this section is 
necessary to address a threat of serious adverse health consequences or 
death, the subpoena may require immediate production.
    ``(c) Service of Subpoena.--Under this section:
            ``(1) In general.--Subpoenas of the Commissioner shall be 
        served by a person authorized by the Commissioner by delivering 
        a copy thereof to the person named therein or by certified mail 
        addressed to such person at such person's last known dwelling 
        place or principal place of business.
            ``(2) Corporations and other entities.--Service on a 
        domestic or foreign corporation, partnership, unincorporated 
        association, or other entity that is subject to suit under a 
        common name may be made by delivering the subpoena to an 
        officer, a managing or general agent, or any other agent 
        authorized by appointment or by law to receive service of 
        process.
            ``(3) Person outside u.s. jurisdiction.--Service on any 
        person not found within the territorial jurisdiction of any 
        court of the United States may be made in any manner as the 
        Federal Rules of Civil Procedure prescribe for service in a 
        foreign nation.
            ``(4) Proof of service.--A verified return by the person so 
        serving the subpoena setting forth the manner of service, or, 
        in the case of service by certified mail, the return post 
        office receipt therefore signed by the person so served, shall 
        be proof of service.
    ``(d) Payment of Witnesses.--Witnesses subpoenaed under subsection 
(a) shall be paid the same fees and mileage as are paid witnesses in 
the district courts of the United States.
    ``(e) Enforcement.--In the case of a refusal to obey a subpoena 
duly served upon any person under subsection (a), any district court of 
the United States for the judicial district in which such person 
charged with refusal to obey is found, resides, or transacts business, 
upon application by the Commissioner, shall have jurisdiction to issue 
an order compelling compliance with the subpoena and requiring such 
person to appear and give testimony or to appear and produce records 
and other things, or both. The failure to obey such order of the court 
may be punished by the court as contempt thereof. If the person charged 
with failure or refusal to obey is not found within the territorial 
jurisdiction of the United States, the United States District Court for 
the District of Columbia shall have the same jurisdiction, consistent 
with due process, to take any action respecting compliance with the 
subpoena by such person that such district court would have if such 
person were personally within the jurisdiction of such district court.
    ``(f) Nondisclosure.--A United States district court for the 
district in which the subpoena is or will be served, upon application 
of the Commissioner, may issue an ex parte order that no person or 
entity disclose to any other person or entity (other than to an 
attorney to obtain legal advice) the existence of such subpoena for a 
period of up to 90 days. Such order may be issued on a showing that the 
records or things being sought may be relevant to the hearing, 
investigation, proceeding, or other matter and that there is reason to 
believe that such disclosure may result in--
            ``(1) furtherance of a potential violation under 
        investigation;
            ``(2) endangerment to the life or physical safety of any 
        person;
            ``(3) flight or other action to avoid prosecution or other 
        enforcement remedies;
            ``(4) destruction of or tampering with evidence; or
            ``(5) intimidation of potential witnesses.
An order under this subsection may be renewed for additional periods of 
up to 90 days upon a showing that any of the circumstances described in 
paragraphs (1) through (5) continue to exist.
    ``(g) Relation to Other Provisions.--The subpoena authority vested 
in the Commissioner and the district courts of the United States by 
this section is in addition to any such authority vested in the 
Commissioner or such courts by other provisions of law, or as is 
otherwise authorized by law.
    ``(h) Nondelegation.--The authority to issue a subpoena under this 
section is limited to the Commissioner or an official designated by the 
Commissioner. An official may not be so designated unless the official 
is the director of the district under this Act in which the drug is 
located, or is an official senior to such director.''.
    (c) Failure To Obey Subpoena.--Section 801 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 381), as amended, is further amended 
by adding at the end the following new subsection:
    ``(u)(1) A drug shall be refused admission if any person who 
manufactures, processes, packs, holds, or ships such drug before it is 
imported or offered for import into the United States fails or refuses 
to obey a subpoena issued pursuant to section 312 and such subpoena was 
issued, in whole or in part, for the purpose of determining whether 
such drug is adulterated, misbranded, or an unapproved new drug.
    ``(2) No drug shall be refused admission under this section based 
on the failure or refusal to obey a subpoena that has been withdrawn by 
the Commissioner or quashed by a United States district court.''.

SEC. 405. WHISTLEBLOWER PROTECTIONS.

    Chapter X of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
391 et seq.), as amended, is further amended by adding at the end the 
following:

``SEC. 1013. PROTECTIONS FOR EMPLOYEES WHO REFUSE TO VIOLATE, OR WHO 
              DISCLOSE VIOLATIONS OF, THIS ACT.

    ``(a) In General.--No person who submits or is required under this 
Act or the Public Health Service Act to submit any information related 
to a drug, or any officer, employee, contractor, subcontractor, or 
agent of such person, may discharge, demote, suspend, threaten, harass, 
or in any other manner discriminate against an employee in the terms 
and conditions of employment because of any lawful act done by the 
employee (including any lawful act that is within the ordinary course 
of the job duties of such employee)--
            ``(1) to provide information, cause information to be 
        provided, or otherwise assist in any investigation regarding 
        any conduct which the employee reasonably believes constitutes 
        a violation of this Act that is related to a drug, or any other 
        provision of Federal law relating to the safety of a drug, if 
        the information or assistance is provided to, or an 
        investigation stemming from the provided information is 
        conducted by--
                    ``(A) a Federal regulatory or law enforcement 
                agency;
                    ``(B) any Member of Congress or any committee of 
                Congress; or
                    ``(C) a person with supervisory authority over the 
                employee (or such other person working for the employer 
                who has the authority to investigate, discover, or 
                terminate the misconduct);
            ``(2) to file, cause to be filed, testify, participate in, 
        or otherwise assist in a proceeding filed, or about to be filed 
        (with any knowledge of the employer), in any court or 
        administrative forum relating to any such alleged violation; or
            ``(3) to refuse to commit or assist in any such violation.
    ``(b) Enforcement Action.--
            ``(1) In general.--An employee who alleges discharge or 
        other discrimination in violation of subsection (a) may seek 
        relief in accordance with the provisions of subsection (c) by--
                    ``(A) filing a complaint with the Secretary of 
                Labor; or
                    ``(B) if the Secretary of Labor has not issued a 
                final decision within 210 days of the filing of the 
                complaint and there is no showing that such delay is 
                due to the bad faith of the claimant, or within 90 days 
                after receiving a final decision or order from the 
                Secretary, bringing an action at law or equity for de 
                novo review in the appropriate district court of the 
                United States, which court shall have jurisdiction over 
                such action without regard to the amount in 
                controversy, and which action shall, at the request of 
                either party to such action, be tried by the court with 
                a jury.
            ``(2) Procedure.--
                    ``(A) In general.--Any action under paragraph (1) 
                shall be governed under the rules and procedures set 
                forth in section 42121(b) of title 49, United States 
                Code.
                    ``(B) Exception.--Notification in an action under 
                paragraph (1) shall be made in accordance with section 
                42121(b)(1) of title 49, United States Code, except 
                that such notification shall be made to the person 
                named in the complaint, the employer, and the 
                Commissioner of Food and Drugs.
                    ``(C) Burdens of proof.--An action brought under 
                paragraph (1)(A) or (1)(B) shall be governed by the 
                legal burdens of proof set forth in section 42121(b) of 
                title 49, United States Code.
                    ``(D) Statute of limitations.--An action under 
                paragraph (1)(A) shall be commenced not later than 180 
                days after the date on which the violation occurs.
    ``(c) Remedies.--
            ``(1) In general.--An employee prevailing in any action 
        under subsection (b)(1) shall be entitled to all relief 
        necessary to make the employee whole.
            ``(2) Issuance of order.--If, in response to a complaint 
        filed under subsection (b)(1), the Secretary of Labor or the 
        district court, as applicable, determines that a violation of 
        subsection (a) has occurred, the Secretary or the court shall 
        order the person who committed such violation--
                    ``(A) to take affirmative action to abate the 
                violation;
                    ``(B) to--
                            ``(i) reinstate the complainant to his or 
                        her former position together with compensation 
                        (including backpay); and
                            ``(ii) restore the terms, conditions, and 
                        privileges associated with his or her 
                        employment; and
                    ``(C) to provide compensatory damages to the 
                complainant.
        If such an order is issued under this paragraph, the Secretary 
        or the court, at the request of the complainant, shall assess 
        against the person against whom the order is issued a sum equal 
        to the aggregate amount of all costs and expenses (including 
        attorney and expert witness fees) reasonably incurred, as 
        determined by the Secretary, by the complainant for, or in 
        connection with, the bringing of the complaint upon which the 
        order was issued.
    ``(d) Rights Retained by Employee.--Nothing in this section shall 
be deemed to diminish the rights, privileges, or remedies of any 
employee under any Federal or State law or under any collective 
bargaining agreement. The rights and remedies in this section may not 
be waived by any agreement, policy, form, or condition of 
employment.''.

SEC. 406. RULE OF CONSTRUCTION.

    Nothing in this Act or any amendment made by this Act shall be 
construed as affecting any authority or requirement relating to devices 
(as defined in section 201 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 321)).
                                 <all>