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U.S. Department of Health and Human Services

Drugs

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Text of Compounding Quality Act

 

TITLE I--DRUG COMPOUNDING
 
    SEC. 101. SHORT TITLE.
    This Act may be cited as the ``Compounding Quality Act''.
    SEC. 102. VOLUNTARY OUTSOURCING FACILITIES.
    (a) In General.--Subchapter A of chapter V (21 U.S.C. 351 et seq.)
is amended--
        (1) by redesignating section 503B as section 503C; and
        (2) by inserting after section 503A the following new section:
``SEC. 503B. OUTSOURCING FACILITIES.
    ``(a) In General.--Sections 502(f)(1), 505, and 582 shall not apply
to a drug compounded by or under the direct supervision of a licensed
pharmacist in a facility that elects to register as an outsourcing
facility if each of the following conditions is met:
        ``(1) Registration and reporting.--The drug is compounded in an
    outsourcing facility that is in compliance with the requirements of
    subsection (b).
        ``(2) Bulk drug substances.--The drug is compounded in an
    outsourcing facility that does not compound using bulk drug
    substances (as defined in section 207.3(a)(4) of title 21, Code of
    Federal Regulations (or any successor regulation)), unless--
            ``(A)(i) the bulk drug substance appears on a list
        established by the Secretary identifying bulk drug substances
        for which there is a clinical need, by--
                ``(I) publishing a notice in the Federal Register
            proposing bulk drug substances to be included on the list,
            including the rationale for such proposal;
                ``(II) providing a period of not less than 60 calendar
            days for comment on the notice; and
                ``(III) publishing a notice in the Federal Register
            designating bulk drug substances for inclusion on the list;
            or
            ``(ii) the drug compounded from such bulk drug substance
        appears on the drug shortage list in effect under section 506E
        at the time of compounding, distribution, and dispensing;
            ``(B) if an applicable monograph exists under the United
        States Pharmacopeia, the National Formulary, or another
        compendium or pharmacopeia recognized by the Secretary for
        purposes of this paragraph, the bulk drug substances each
        comply with the monograph;
            ``(C) the bulk drug substances are each manufactured by an
        establishment that is registered under section 510 (including a
        foreign establishment that is registered under section 510(i));
        and
            ``(D) the bulk drug substances are each accompanied by a
        valid certificate of analysis.
        ``(3) Ingredients (other than bulk drug substances).--If any
    ingredients (other than bulk drug substances) are used in
    compounding the drug, such ingredients comply with the standards of
    the applicable United States Pharmacopeia or National Formulary
    monograph, if such monograph exists, or of another compendium or
    pharmacopeia recognized by the Secretary for purposes of this
    paragraph if any.
        ``(4) Drugs withdrawn or removed because unsafe or not
    effective.--The drug does not appear on a list published by the
    Secretary of drugs that have been withdrawn or removed from the
    market because such drugs or components of such drugs have been
    found to be unsafe or not effective.
        ``(5) Essentially a copy of an approved drug.--The drug is not
    essentially a copy of one or more approved drugs.
        ``(6) Drugs presenting demonstrable difficulties for
    compounding.--The drug--
            ``(A) is not identified (directly or as part of a category
        of drugs) on a list published by the Secretary, through the
        process described in subsection (c), of drugs or categories of
        drugs that present demonstrable difficulties for compounding
        that are reasonably likely to lead to an adverse effect on the
        safety or effectiveness of the drug or category of drugs,
        taking into account the risks and benefits to patients; or
            ``(B) is compounded in accordance with all applicable
        conditions identified on the list described in subparagraph (A)
        as conditions that are necessary to prevent the drug or
        category of drugs from presenting the demonstrable difficulties
        described in subparagraph (A).
        ``(7) Elements to assure safe use.--In the case of a drug that
    is compounded from a drug that is the subject of a risk evaluation
    and mitigation strategy approved with elements to assure safe use
    pursuant to section 505-1, or from a bulk drug substance that is a
    component of such drug, the outsourcing facility demonstrates to
    the Secretary prior to beginning compounding that such facility
    will utilize controls comparable to the controls applicable under
    the relevant risk evaluation and mitigation strategy.
        ``(8) Prohibition on wholesaling.--The drug will not be sold or
    transferred by an entity other than the outsourcing facility that
    compounded such drug. This paragraph does not prohibit
    administration of a drug in a health care setting or dispensing a
    drug pursuant to a prescription executed in accordance with section
    503(b)(1).
        ``(9) Fees.--The drug is compounded in an outsourcing facility
    that has paid all fees owed by such facility pursuant to section
    744K.
        ``(10) Labeling of drugs.--
            ``(A) Label.--The label of the drug includes--
                ``(i) the statement `This is a compounded drug.' or a
            reasonable comparable alternative statement (as specified
            by the Secretary) that prominently identifies the drug as a
            compounded drug;
                ``(ii) the name, address, and phone number of the
            applicable outsourcing facility; and
                ``(iii) with respect to the drug--
 
                    ``(I) the lot or batch number;
                    ``(II) the established name of the drug;
                    ``(III) the dosage form and strength;
                    ``(IV) the statement of quantity or volume, as
                appropriate;
                    ``(V) the date that the drug was compounded;
                    ``(VI) the expiration date;
                    ``(VII) storage and handling instructions;
                    ``(VIII) the National Drug Code number, if
                available;
                    ``(IX) the statement `Not for resale', and, if the
                drug is dispensed or distributed other than pursuant to
                a prescription for an individual identified patient,
                the statement `Office Use Only'; and
                    ``(X) subject to subparagraph (B)(i), a list of
                active and inactive ingredients, identified by
                established name and the quantity or proportion of each
                ingredient.
 
            ``(B) Container.--The container from which the individual
        units of the drug are removed for dispensing or for
        administration (such as a plastic bag containing individual
        product syringes) shall include--
                ``(i) the information described under subparagraph
            (A)(iii)(X), if there is not space on the label for such
            information;
                ``(ii) the following information to facilitate adverse
            event reporting: www.fda.gov/medwatch and 1-800-FDA-1088
            (or any successor Internet Web site or phone number); and
                ``(iii) directions for use, including, as appropriate,
            dosage and administration.
            ``(C) Additional information.--The label and labeling of
        the drug shall include any other information as determined
        necessary and specified in regulations promulgated by the
        Secretary.
        ``(11) Outsourcing facility requirement.--The drug is
    compounded in an outsourcing facility in which the compounding of
    drugs occurs only in accordance with this section.
    ``(b) Registration of Outsourcing Facilities and Reporting of
Drugs.--
        ``(1) Registration of outsourcing facilities.--
            ``(A) Annual registration.--Upon electing and in order to
        become an outsourcing facility, and during the period beginning
        on October 1 and ending on December 31 of each year thereafter,
        a facility--
                ``(i) shall register with the Secretary its name, place
            of business, and unique facility identifier (which shall
            conform to the requirements for the unique facility
            identifier established under section 510), and a point of
            contact email address; and
                ``(ii) shall indicate whether the outsourcing facility
            intends to compound a drug that appears on the list in
            effect under section 506E during the subsequent calendar
            year.
            ``(B) Availability of registration for inspection; list.--
                ``(i) Registrations.--The Secretary shall make
            available for inspection, to any person so requesting, any
            registration filed pursuant to this paragraph.
                ``(ii) List.--The Secretary shall make available on the
            public Internet Web site of the Food and Drug
            Administration a list of the name of each facility
            registered under this subsection as an outsourcing
            facility, the State in which each such facility is located,
            whether the facility compounds from bulk drug substances,
            and whether any such compounding from bulk drug substances
            is for sterile or nonsterile drugs.
        ``(2) Drug reporting by outsourcing facilities.--
            ``(A) In general.--Upon initially registering as an
        outsourcing facility, once during the month of June of each
        year, and once during the month of December of each year, each
        outsourcing facility that registers with the Secretary under
        paragraph (1) shall submit to the Secretary a report--
                ``(i) identifying the drugs compounded by such
            outsourcing facility during the previous 6-month period;
            and
                ``(ii) with respect to each drug identified under
            clause (i), providing the active ingredient, the source of
            such active ingredient, the National Drug Code number of
            the source drug or bulk active ingredient, if available,
            the strength of the active ingredient per unit, the dosage
            form and route of administration, the package description,
            the number of individual units produced, and the National
            Drug Code number of the final product, if assigned.
            ``(B) Form.--Each report under subparagraph (A) shall be
        prepared in such form and manner as the Secretary may prescribe
        by regulation or guidance.
            ``(C) Confidentiality.--Reports submitted under this
        paragraph shall be exempt from inspection under paragraph
        (1)(B)(i), unless the Secretary finds that such an exemption
        would be inconsistent with the protection of the public health.
        ``(3) Electronic registration and reporting.--Registrations and
    drug reporting under this subsection (including the submission of
    updated information) shall be submitted to the Secretary by
    electronic means unless the Secretary grants a request for waiver
    of such requirement because use of electronic means is not
    reasonable for the person requesting waiver.
        ``(4) Risk-based inspection frequency.--
            ``(A) In general.--Outsourcing facilities--
                ``(i) shall be subject to inspection pursuant to
            section 704; and
                ``(ii) shall not be eligible for the exemption under
            section 704(a)(2)(A).
            ``(B) Risk-based schedule.--The Secretary, acting through
        one or more officers or employees duly designated by the
        Secretary, shall inspect outsourcing facilities in accordance
        with a risk-based schedule established by the Secretary.
            ``(C) Risk factors.--In establishing the risk-based
        schedule, the Secretary shall inspect outsourcing facilities
        according to the known safety risks of such outsourcing
        facilities, which shall be based on the following factors:
                ``(i) The compliance history of the outsourcing
            facility.
                ``(ii) The record, history, and nature of recalls
            linked to the outsourcing facility.
                ``(iii) The inherent risk of the drugs compounded at
            the outsourcing facility.
                ``(iv) The inspection frequency and history of the
            outsourcing facility, including whether the outsourcing
            facility has been inspected pursuant to section 704 within
            the last 4 years.
                ``(v) Whether the outsourcing facility has registered
            under this paragraph as an entity that intends to compound
            a drug that appears on the list in effect under section
            506E.
                ``(vi) Any other criteria deemed necessary and
            appropriate by the Secretary for purposes of allocating
            inspection resources.
        ``(5) Adverse event reporting.--Outsourcing facilities shall
    submit adverse event reports to the Secretary in accordance with
    the content and format requirements established through guidance or
    regulation under section 310.305 of title 21, Code of Federal
    Regulations (or any successor regulations).
    ``(c) Regulations.--
        ``(1) In general.--The Secretary shall implement the list
    described in subsection (a)(6) through regulations.
        ``(2) Advisory committee on compounding.--Before issuing
    regulations to implement subsection (a)(6), the Secretary shall
    convene and consult an advisory committee on compounding. The
    advisory committee shall include representatives from the National
    Association of Boards of Pharmacy, the United States Pharmacopeia,
    pharmacists with current experience and expertise in compounding,
    physicians with background and knowledge in compounding, and
    patient and public health advocacy organizations.
        ``(3) Interim list.--
            ``(A) In general.--Before the effective date of the
        regulations finalized to implement subsection (a)(6), the
        Secretary may designate drugs, categories of drugs, or
        conditions as described such subsection by--
                ``(i) publishing a notice of such substances, drugs,
            categories of drugs, or conditions proposed for
            designation, including the rationale for such designation,
            in the Federal Register;
                ``(ii) providing a period of not less than 60 calendar
            days for comment on the notice; and
                ``(iii) publishing a notice in the Federal Register
            designating such drugs, categories of drugs, or conditions.
            ``(B) Sunset of notice.--Any notice provided under
        subparagraph (A) shall not be effective after the earlier of--
                ``(i) the date that is 5 years after the date of
            enactment of the Compounding Quality Act; or
                ``(ii) the effective date of the final regulations
            issued to implement subsection (a)(6).
        ``(4) Updates.--The Secretary shall review, and update as
    necessary, the regulations containing the lists of drugs,
    categories of drugs, or conditions described in subsection (a)(6)
    regularly, but not less than once every 4 years. Nothing in the
    previous sentence prohibits submissions to the Secretary, before or
    during any 4-year period described in such sentence, requesting
    updates to such lists.
    ``(d) Definitions.--In this section:
        ``(1) The term `compounding' includes the combining, admixing,
    mixing, diluting, pooling, reconstituting, or otherwise altering of
    a drug or bulk drug substance to create a drug.
        ``(2) The term `essentially a copy of an approved drug' means--
            ``(A) a drug that is identical or nearly identical to an
        approved drug, or a marketed drug not subject to section 503(b)
        and not subject to approval in an application submitted under
        section 505, unless, in the case of an approved drug, the drug
        appears on the drug shortage list in effect under section 506E
        at the time of compounding, distribution, and dispensing; or
            ``(B) a drug, a component of which is a bulk drug substance
        that is a component of an approved drug or a marketed drug that
        is not subject to section 503(b) and not subject to approval in
        an application submitted under section 505, unless there is a
        change that produces for an individual patient a clinical
        difference, as determined by the prescribing practitioner,
        between the compounded drug and the comparable approved drug.
        ``(3) The term `approved drug' means a drug that is approved
    under section 505 and does not appear on the list described in
    subsection (a)(4) of drugs that have been withdrawn or removed from
    the market because such drugs or components of such drugs have been
    found to be unsafe or not effective.
        ``(4)(A) The term `outsourcing facility' means a facility at
    one geographic location or address that--
            ``(i) is engaged in the compounding of sterile drugs;
            ``(ii) has elected to register as an outsourcing facility;
        and
            ``(iii) complies with all of the requirements of this
        section.
        ``(B) An outsourcing facility is not required to be a licensed
    pharmacy.
        ``(C) An outsourcing facility may or may not obtain
    prescriptions for identified individual patients.
        ``(5) The term `sterile drug' means a drug that is intended for
    parenteral administration, an ophthalmic or oral inhalation drug in
    aqueous format, or a drug that is required to be sterile under
    Federal or State law.''.
    ``(d) Obligation to Pay Fees.--Payment of the fee under section
744K, as described in subsection (a)(9), shall not relieve an
outsourcing facility that is licensed as a pharmacy in any State that
requires pharmacy licensing fees of its obligation to pay such State
fees.''.
    (b) Fees.--Subchapter C of chapter VII (21 U.S.C. 379f et seq.) is
amended by adding at the end the following:
 
           ``PART 9--FEES RELATING TO OUTSOURCING FACILITIES
 
``SEC. 744J. DEFINITIONS.
    ``In this part:
        ``(1) The term `affiliate' has the meaning given such term in
    section 735(11).
        ``(2) The term `gross annual sales' means the total worldwide
    gross annual sales, in United States dollars, for an outsourcing
    facility, including the sales of all the affiliates of the
    outsourcing facility.
        ``(3) The term `outsourcing facility' has the meaning given to
    such term in section 503B(d)(4).
        ``(4) The term `reinspection' means, with respect to an
    outsourcing facility, 1 or more inspections conducted under section
    704 subsequent to an inspection conducted under such provision
    which identified noncompliance materially related to an applicable
    requirement of this Act, specifically to determine whether
    compliance has been achieved to the Secretary's satisfaction.
``SEC. 744K. AUTHORITY TO ASSESS AND USE OUTSOURCING FACILITY FEES.
    ``(a) Establishment and Reinspection Fees.--
        ``(1) In general.--For fiscal year 2015 and each subsequent
    fiscal year, the Secretary shall, in accordance with this
    subsection, assess and collect--
            ``(A) an annual establishment fee from each outsourcing
        facility; and
            ``(B) a reinspection fee from each outsourcing facility
        subject to a reinspection in such fiscal year.
        ``(2) Multiple reinspections.--An outsourcing facility subject
    to multiple reinspections in a fiscal year shall be subject to a
    reinspection fee for each reinspection.
    ``(b) Establishment and Reinspection Fee Setting.--The Secretary
shall--
        ``(1) establish the amount of the establishment fee and
    reinspection fee to be collected under this section for each fiscal
    year based on the methodology described in subsection (c); and
        ``(2) publish such fee amounts in a Federal Register notice not
    later than 60 calendar days before the start of each such year.
    ``(c) Amount of Establishment Fee and Reinspection Fee.--
        ``(1) In general.--For each outsourcing facility in a fiscal
    year--
            ``(A) except as provided in paragraph (4), the amount of
        the annual establishment fee under subsection (b) shall be
        equal to the sum of--
                ``(i) $15,000, multiplied by the inflation adjustment
            factor described in paragraph (2); plus
                ``(ii) the small business adjustment factor described
            in paragraph (3); and
            ``(B) the amount of any reinspection fee (if applicable)
        under subsection (b) shall be equal to $15,000, multiplied by
        the inflation adjustment factor described in paragraph (2).
        ``(2) Inflation adjustment factor.--
            ``(A) In general.--For fiscal year 2015 and subsequent
        fiscal years, the fee amounts established in paragraph (1)
        shall be adjusted by the Secretary by notice, published in the
        Federal Register, for a fiscal year by the amount equal to the
        sum of--
                ``(i) 1;
                ``(ii) the average annual percent 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 3 years
            of the preceding 4 fiscal years, multiplied by the
            proportion of personnel compensation and benefits costs to
            total costs of an average full-time equivalent position of
            the Food and Drug Administration for the first 3 years of
            the preceding 4 fiscal years; plus
                ``(iii) the average annual percent change that occurred
            in the Consumer Price Index for urban consumers (U.S. City
            Average; Not Seasonally Adjusted; All items; Annual Index)
            for the first 3 years of the preceding 4 years of available
            data multiplied by the proportion of all costs other than
            personnel compensation and benefits costs to total costs of
            an average full-time equivalent position of the Food and
            Drug Administration for the first 3 years of the preceding
            4 fiscal years.
            ``(B) Compounded basis.--The adjustment made each fiscal
        year under subparagraph (A) shall be added on a compounded
        basis to the sum of all adjustments made each fiscal year after
        fiscal year 2014 under subparagraph (A).
        ``(3) Small business adjustment factor.--The small business
    adjustment factor described in this paragraph shall be an amount
    established by the Secretary for each fiscal year based on the
    Secretary's estimate of--
            ``(A) the number of small businesses that will pay a
        reduced establishment fee for such fiscal year; and
            ``(B) the adjustment to the establishment fee necessary to
        achieve total fees equaling the total fees that the Secretary
        would have collected if no entity qualified for the small
        business exception in paragraph (4).
        ``(4) Exception for small businesses.--
            ``(A) In general.--In the case of an outsourcing facility
        with gross annual sales of $1,000,000 or less in the 12 months
        ending April 1 of the fiscal year immediately preceding the
        fiscal year in which the fees under this section are assessed,
        the amount of the establishment fee under subsection (b) for a
        fiscal year shall be equal to \1/3\ of the amount calculated
        under paragraph (1)(A)(i) for such fiscal year.
            ``(B) Application.--To qualify for the exception under this
        paragraph, a small business shall submit to the Secretary a
        written request for such exception, in a format specified by
        the Secretary in guidance, certifying its gross annual sales
        for the 12 months ending April 1 of the fiscal year immediately
        preceding the fiscal year in which fees under this subsection
        are assessed. Any such application shall be submitted to the
        Secretary not later than April 30 of such immediately preceding
        fiscal year.
       ``(5) Crediting of fees.--In establishing the small business
    adjustment factor under paragraph (3) for a fiscal year, the
    Secretary shall--
            ``(A) provide for the crediting of fees from the previous
        year to the next year if the Secretary overestimated the amount
        of the small business adjustment factor for such previous
        fiscal year; and
            ``(B) consider the need to account for any adjustment of
        fees and such other factors as the Secretary determines
        appropriate.
    ``(d) Use of Fees.--The Secretary shall make all of the fees
collected pursuant to subparagraphs (A) and (B) of subsection (a)(1)
available solely to pay for the costs of oversight of outsourcing
facilities.
    ``(e) Supplement Not Supplant.--Funds received by the Secretary
pursuant to this section shall be used to supplement and not supplant
any other Federal funds available to carry out the activities described
in this section.
    ``(f) Crediting and Availability of Fees.--Fees authorized under
this section 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. The sums transferred shall
be available solely for the purpose of paying the costs of oversight of
outsourcing facilities.
    ``(g) Collection of Fees.--
        ``(1) Establishment fee.--An outsourcing facility shall remit
    the establishment fee due under this section in a fiscal year when
    submitting a registration pursuant to section 503B(b) for such
    fiscal year.
        ``(2) Reinspection fee.--The Secretary shall specify in the
    Federal Register notice described in subsection (b)(2) the manner
    in which reinspection fees assessed under this section shall be
    collected and the timeline for payment of such fees. Such a fee
    shall be collected after the Secretary has conducted a reinspection
    of the outsourcing facility involved.
       ``(3) Effect of failure to pay fees.--
            ``(A) Registration.--An outsourcing facility shall not be
        considered registered under section 503B(b) in a fiscal year
        until the date that the outsourcing facility remits the
        establishment fee under this subsection for such fiscal year.
            ``(B) Misbranding.--All drugs manufactured, prepared,
        propagated, compounded, or processed by an outsourcing facility
        for which any establishment fee or reinspection fee has not
        been paid, as required by this section, shall be deemed
        misbranded under section 502 until the fees owed for such
        outsourcing facility under this section have been paid.
        ``(4) Collection of unpaid fees.--In any case where the
    Secretary does not receive payment of a fee assessed under this
    section within 30 calendar days after it is due, such fee shall be
    treated as a claim of the United States Government subject to
    provisions of subchapter II of chapter 37 of title 31, United
    States Code.
    ``(h) Annual Report to Congress.--Not later than 120 calendar days
after each fiscal year in which fees are assessed and collected under
this section, the Secretary shall submit a report to the Committee on
Health, Education, Labor, and Pensions of the Senate and the Committee
on Energy and Commerce of the House of Representatives, to include a
description of fees assessed and collected for such year, a summary
description of entities paying the fees, a description of the hiring
and placement of new staff, a description of the use of fee resources
to support inspecting outsourcing facilities, and the number of
inspections and reinspections of such facilities performed each year.
    ``(i) Authorization of Appropriations.--For fiscal year 2014 and
each subsequent fiscal year, there is authorized to be appropriated for
fees under this section an amount equivalent to the total amount of
fees assessed for such fiscal year under this section.''.
    SEC. 103. PENALTIES.
    (a) Prohibited Acts.--Section 301 (21 U.S.C. 331) is amended by
adding at the end the following:
    ``(ccc)(1) The resale of a compounded drug that is labeled `not for
resale' in accordance with section 503B.
    ``(2) With respect to a drug to be compounded pursuant to section
503A or 503B, the intentional falsification of a prescription, as
applicable.
    ``(3) The failure to report drugs or adverse events by an entity
that is registered in accordance with subsection (b) of section
503B.''.
    (b) Misbranded Drugs.--Section 502 (21 U.S.C. 352) is amended by
adding at the end the following:
    ``(bb) If the advertising or promotion of a compounded drug is
false or misleading in any particular.''.
    SEC. 104. REGULATIONS.
    In promulgating any regulations to implement this title (and the
amendments made by this title), the Secretary of Health and Human
Services shall--
        (1) issue a notice of proposed rulemaking that includes the
    proposed regulation;
        (2) provide a period of not less than 60 calendar days for
    comments on the proposed regulation; and
        (3) publish the final regulation not more than 18 months
    following publication of the proposed rule and not less than 30
    calendar days before the effective date of such final regulation.
    SEC. 105. ENHANCED COMMUNICATION.
    (a) Submissions From State Boards of Pharmacy.--In a manner
specified by the Secretary of Health and Human Services (referred to in
this section as the ``Secretary''), the Secretary shall receive
submissions from State boards of pharmacy--
        (1) describing actions taken against compounding pharmacies, as
    described in subsection (b); or
        (2) expressing concerns that a compounding pharmacy may be
    acting contrary to section 503A of the Federal Food, Drug, and
    Cosmetic Act (21 U.S.C. 353a).
    (b) Content of Submissions From State Boards of Pharmacy.--An
action referred to in subsection (a)(1) is, with respect to a pharmacy
that compounds drugs, any of the following:
        (1) The issuance of a warning letter, or the imposition of
    sanctions or penalties, by a State for violations of a State's
    pharmacy regulations pertaining to compounding.
        (2) The suspension or revocation of a State-issued pharmacy
    license or registration for violations of a State's pharmacy
    regulations pertaining to compounding.
        (3) The recall of a compounded drug due to concerns relating to
    the quality or purity of such drug.
    (c) Consultation.--The Secretary shall implement subsection (a) in
consultation with the National Association of Boards of Pharmacy.
    (d) Notifying State Boards of Pharmacy.--The Secretary shall
immediately notify State boards of pharmacy when--
        (1) the Secretary receives a submission under subsection
    (a)(1); or
        (2) the Secretary makes a determination that a pharmacy is
    acting contrary to section 503A of the Federal Food, Drug, and
    Cosmetic Act.
    SEC. 106. SEVERABILITY.
    (a) In General.--Section 503A (21 U.S.C. 353a) is amended--
        (1) in subsection (a), in the matter preceding paragraph (1),
    by striking ``unsolicited'';
        (2) by striking subsection (c);
        (3) by redesignating subsections (d) through (f) as subsections
    (c) through (e), respectively; and
        (4) in subsection (b)(1)(A)(i)(III), by striking ``subsection
    (d)'' and inserting ``subsection (c)''.
    (b) Severability.--If any provision of this Act (including the
amendments made by this Act) is declared unconstitutional, or the
applicability of this Act (including the amendments made by this Act)
to any person or circumstance is held invalid, the constitutionality of
the remainder of this Act (including the amendments made by this Act)
and the applicability thereof to other persons and circumstances shall
not be affected.
    SEC. 107. GAO STUDY.
    (a) Study.--Not later than 36 months after the date of the
enactment of this Act, the Comptroller General of the United States
shall submit to Congress a report on pharmacy compounding and the
adequacy of State and Federal efforts to assure the safety of
compounded drugs.
    (b) Contents.--The report required under this section shall
include--
        (1) a review of pharmacy compounding in each State, and the
    settings in which such compounding occurs;
        (2) a review of the State laws and policies governing pharmacy
    compounding, including enforcement of State laws and policies;
        (3) an assessment of the available tools to permit purchasers
    of compounded drugs to determine the safety and quality of such
    drugs;
        (4) an evaluation of the effectiveness of the communication
    among States and between States and the Food and Drug
    Administration regarding compounding; and
        (5) an evaluation of the Food and Drug Administration's
    implementation of sections 503A and 503B of the Federal Food, Drug,
    and Cosmetic Act.