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[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2186 Introduced in House (IH)]

113th CONGRESS
  1st Session
                                H. R. 2186

 To amend the Federal Food, Drug, and Cosmetic Act to provide for the 
                     compounding of drug products.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                              May 23, 2013

   Mr. Markey (for himself, Ms. Slaughter, Mr. Clay, and Mr. Rangel) 
 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 provide for the 
                     compounding of drug products.

    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 ``Verifying Authority and Legality In 
Drug Compounding Act of 2013'' or the ``VALID Compounding Act''.

SEC. 2. APPLICATION OF FEDERAL LAW TO PRACTICE OF PHARMACY COMPOUNDING.

    (a) Amendment.--Section 503A of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 353a) is amended to read as follows:

``SEC. 503A. PHARMACY COMPOUNDING.

    ``(a) In General.--Sections 501(a)(2)(B), 502(f)(1), and 505 shall 
not apply with respect to a drug product if each of the following 
applies:
            ``(1) Except as provided in subsection (d), the drug 
        product is compounded for an identified individual patient 
        based on the receipt of a prescription order.
            ``(2) The drug product is compounded by a licensed 
        pharmacist in a State-licensed pharmacy or a Federal facility, 
        or by a licensed physician, pursuant to such prescription order 
        or notation.
            ``(3) In the case of a drug product that is compounded 
        using bulk substances (as defined in section 207.3(a)(4) of 
        title 21, Code of Federal Regulations (or any successor 
        regulations)--
                    ``(A) such bulk substances--
                            ``(i) are components of one or more drugs 
                        for which an approval of an application filed 
                        under subsection (b) or (j) of section 505 is 
                        in effect;
                            ``(ii) are components of drugs that may be 
                        lawfully marketed in the United States without 
                        such an approval pursuant to the definition of 
                        a new drug in section 201; or
                            ``(iii) appear on the list in effect under 
                        subsection (b); and
                    ``(B) such bulk substances comply with the 
                standards of an applicable United States Pharmacopeia 
                or National Formulary monograph, if a monograph exists.
            ``(4) Any bulk substance used for purposes of compounding 
        the drug product--
                    ``(A) is manufactured by an establishment that is 
                registered under section 510 (including a foreign 
                establishment that is registered under section 510(i)); 
                and
                    ``(B) is accompanied by valid certificates of 
                analysis.
            ``(5) The pharmacist or physician compounding the drug 
        product complies with the standards of any applicable United 
        States Pharmacopeia chapters on pharmacy compounding.
            ``(6) The drug product, including the dosage form and any 
        ingredient thereof--
                    ``(A) is not included in the list under subsection 
                (c); and
                    ``(B) is not withdrawn or removed from the market 
                because such drug product or any ingredient thereof has 
                been found to be unsafe or not effective.
            ``(7) Subject to subsection (e), the drug product is not a 
        copy of a commercially available drug.
            ``(8) If the drug product is produced using high-risk 
        sterile compounding, the drug product is compounded in 
        accordance with the standards, processes, and procedures 
        established under subsection (f).
    ``(b) List of Bulk Substances From Which Drug Products May Be 
Compounded.--
            ``(1) In general.--For purposes of subsection 
        (a)(3)(A)(iii), the Secretary shall, by guidance--
                    ``(A) develop and maintain a list of bulk 
                substances from which drug products may be compounded; 
                and
                    ``(B) include in the list only bulk substances that 
                are not described in clause (i) or (ii) of subsection 
                (a)(3)(A) and may be compounded to meet a medical need 
                that cannot be filled by using a bulk substance that is 
                described in such clause (i) or (ii);
                    ``(C) specify for each bulk substance on the list 
                under this subsection any limitation on compounding the 
                bulk substance; and
                    ``(D) specify for each bulk substance on the list 
                under this subsection the particular medical need that 
                is met by placing such substance on the list.
            ``(2) Initial publication; updates.--The Secretary shall--
                    ``(A) not later than 1 year after the date of the 
                enactment of the Verifying Authority and Legality In 
                Drug Compounding Act of 2013, publish an initial list 
                under paragraph (1); and
                    ``(B) not less frequently than every year 
                thereafter, review and, as appropriate, update the list 
                under paragraph (1).
            ``(3) Availability.--The Secretary shall make the list 
        under paragraph (1) available on the public Web site of the 
        Food and Drug Administration.
            ``(4) Transmission to state regulatory agencies.--Upon 
        publication of the initial list under paragraph (1), and upon 
        each update to the list, the Secretary shall transmit an up-to-
        date copy of the list to the agency in each State with primary 
        responsibility for regulating pharmacies.
            ``(5) Petitions.--
                    ``(A) In general.--In carrying out this subsection, 
                the Secretary shall receive and consider petitions from 
                any person identifying a substance that should be added 
                to, or removed from, the list under this subsection.
                    ``(B) Requirement for petitions seeking to add a 
                bulk substance.--Any petition seeking to add a bulk 
                substance to the list under this subsection shall 
                specify the reasons--
                            ``(i) why the bulk substance is needed for 
                        a procedure or population; and
                            ``(ii) why such need is not met by bulk 
                        substances that are described in clause (i) or 
                        (ii) of subsection (a)(3)(A).
                    ``(C) Approval or denial.--The Secretary shall 
                approve or deny any petition received under this 
                paragraph, and update the list under paragraph (1) 
                accordingly, not later than 90 days after receipt of 
                the petition, unless an extension of time is mutually 
                agreed upon by the Secretary and the petitioner.
                    ``(D) Final agency action.--A decision of the 
                Secretary to approve or deny a petition received under 
                this paragraph shall constitute final agency action 
                subject to judicial review.
                    ``(E) Public posting.--The Secretary shall 
                publically post--
                            ``(i) all petitions received under this 
                        paragraph within 21 days of receipt; and
                            ``(ii) each approval, denial, and extension 
                        under subparagraph (C) promptly.
    ``(c) List of Drug Products That Should Not Be Compounded.--
            ``(1) In general.--For purposes of subsection (a)(6), the 
        Secretary shall, by guidance--
                    ``(A) develop and maintain a list of drug products 
                that should not be compounded, including any 
                categories, dosage forms, or ingredients of such drug 
                products; and
                    ``(B) include on such list, at a minimum--
                            ``(i) drug products (or categories, dosage 
                        forms, or ingredients thereof) whose 
                        compounding is reasonably likely to cause an 
                        adverse effect on safety or effectiveness of 
                        such drug product, including extended release 
                        products, metered dose inhalers, transdermal 
                        patches, and liposomal products; and
                            ``(ii) drug products (or categories, dosage 
                        forms, or ingredients thereof) that have been 
                        withdrawn or removed from the market because 
                        they have been found to be unsafe or not 
                        effective.
            ``(2) Applicability of certain provisions.--The provisions 
        of paragraphs (2), (3), and (4) of subsection (b) shall apply 
        with respect to the list under this subsection to the same 
        extent and in the same manner as such provisions apply with 
        respect to the list under subsection (b).
            ``(3) Petitions.--In carrying out this subsection, the 
        Secretary shall receive and consider petitions from any person 
        identifying a drug product that should be added to, or removed 
        from, the list under this subsection. Subparagraphs (C) through 
        (E) of subsection (b)(2) shall apply with respect to petitions 
        under this paragraph to the same extent and in the same manner 
        as such subparagraphs apply with respect to petitions under 
        subsection (b)(5).
    ``(d) Exception to Requirement of Identified Individual Patient.--
            ``(1) In general.--A pharmacy or pharmacist that is not 
        required to be registered under section 510 may compound a drug 
        product without regard to subsection (a)(1) if the pharmacy or 
        pharmacist--
                    ``(A) registers with the Secretary as specified 
                pursuant to paragraph (2); and
                    ``(B) agrees to comply with any condition of 
                operation or limitation of activity specified by the 
                Secretary, including the conditions and limitations 
                specified pursuant to paragraph (2).
            ``(2) Registration and requirements.--The Secretary shall 
        specify by regulation for each type of pharmacy or pharmacist 
        compounding drug products pursuant to the exception under this 
        subsection--
                    ``(A) the registration requirements for such 
                pharmacy or pharmacist and the information that must be 
                submitted with the registration, which information 
                shall include--
                            ``(i) the name and location of the 
                        pharmacy;
                            ``(ii) the types of drugs that are 
                        compounded;
                            ``(iii) the active ingredients in each such 
                        drug;
                            ``(iv) the source and strength of the 
                        active ingredient in each drug;
                            ``(v) the dosage form and route of 
                        administration of each drug;
                            ``(vi) the number of individual units 
                        produced of each drug;
                            ``(vii) the States to which drugs were 
                        shipped;
                            ``(viii) the number of individual units of 
                        each drug that are shipped to each State; and
                            ``(ix) affirmation that the pharmacy or 
                        pharmacist is in compliance with State pharmacy 
                        licensing regulations;
                    ``(B) the frequency in which information described 
                in subparagraph (A) must be submitted;
                    ``(C) the conditions of operation, including good 
                manufacturing practices and requirements for third-
                party testing, applicable to the compounding of drugs; 
                and
                    ``(D) any limitations on the activities of such 
                pharmacy or pharmacist.
            ``(3) Types of pharmacies eligible.--The Secretary shall 
        specify separate requirements for each type of pharmacy and 
        pharmacist authorized to compound drug products pursuant to the 
        exception under this subsection. The Secretary shall include 
        separate requirements for--
                    ``(A) any pharmacy or pharmacist within a hospital 
                system that is compounding drug products exclusively 
                for dispensing to patients within that hospital system; 
                and
                    ``(B) any pharmacy or pharmacist that compounds 
                sterile drug products.
            ``(4) Memorandum of understanding.--
                    ``(A) In general.--Subject to subparagraph (C), the 
                Secretary may enter into appropriate memoranda of 
                understanding with States to address State 
                implementation of the exception under this subsection--
                            ``(i) ensuring, to the Secretary's 
                        satisfaction, that the State will implement the 
                        exception under this subsection in accordance 
                        with the requirements of this section; and
                            ``(ii) including such other information and 
                        assurances as the Secretary may require.
                    ``(B) Process; criteria.--The Secretary shall--
                            ``(i) establish a process and criteria for 
                        entering into a memorandum of understanding 
                        under this paragraph, including the sharing of 
                        information between State and Federal 
                        authorities; and
                            ``(ii) reevaluate each such memorandum of 
                        understanding not less than every 5 years to 
                        ensure, to the Secretary's satisfaction, that 
                        the State's implementation of the memorandum of 
                        understanding continues to conform to the 
                        requirements of this section.
                    ``(C) Exclusive federal authority.--The Secretary 
                shall retain exclusive Federal authority to implement 
                the exception under this subsection with respect to 
                pharmacies and pharmacists that--
                            ``(i) perform high-risk sterile 
                        compounding; or
                            ``(ii) compound drug products for shipment 
                        across State lines.
            ``(5) Maintenance of list.--The Secretary shall maintain a 
        publically available list--
                    ``(A) identifying all pharmacies and pharmacists 
                registered under this subsection; and
                    ``(B) indicating, for each such pharmacy and 
                pharmacist, whether the pharmacy or pharmacist is 
                subject to regulation by a State pursuant to a 
                memorandum of understanding in effect under paragraph 
                (4).
    ``(e) Exceptions Regarding Copies of Commercially Available 
Drugs.--A drug that is a copy of a commercially available drug may be 
compounded pursuant to this section without regard to subsection (a)(7) 
if--
            ``(1)(A) the commercially available drug that is being 
        compounded is at the time of distribution on the drug shortage 
        list under section 506E, and the pharmacy has provided notice 
        to the Secretary that such drug is being compounded not later 
        than 5 days after distributing such drug; or
            ``(B) the Secretary determines that compounding the drug 
        product is necessary to protect public health or wellbeing; and
            ``(2) in the case of a commercially available drug marketed 
        pursuant to a risk evaluation and mitigation strategy approved 
        under section 505-1 and including one or more elements to 
        assure safe use, the pharmacy or pharmacist compounding the 
        drug that is a copy of such commercially available drug 
        demonstrates to the Secretary that controls will be used that 
        are comparable to such elements to assure safe use.
    ``(f) High-Risk Sterile Compounding.--For purposes of subsection 
(a)(8), the Secretary shall establish standards, processes, and 
procedures for high-risk sterile compounding.
    ``(g) Inspections.--Notwithstanding section 704(a)(2)(A), the 
facilities of any pharmacy or pharmacist compounding drug products 
under this section--
            ``(1) shall be subject to inspection under section 704; and
            ``(2) shall, upon request of an officer or employee 
        designated by the Secretary, permit such officer or employee at 
        all reasonable times to have access to, and to copy and verify, 
        records for purposes of determining compliance with the 
        provisions of this Act applicable to such compounding.
    ``(h) Sharing of Information.--If during an inspection of the 
facilities of a pharmacy or pharmacist under this section the Secretary 
discovers a violation of this Act, the Secretary shall give notice of 
the violation--
            ``(1) to the State in which the facilities are located; and
            ``(2) to any State to which the pharmacy or pharmacist has 
        shipped a drug product during the preceding 30 days.
    ``(i) Labeling.--The labeling of any drug product compounded 
pursuant to this section shall include--
            ``(1) the name of each drug and ingredient included;
            ``(2) the name, address, and phone number of the licensed 
        compounding pharmacy, pharmacist, or physician;
            ``(3) the date on which the drug was compounded;
            ``(4) instructions for storage and use;
            ``(5) the following statement: `This drug has not been 
        tested for safety and effectiveness and is not approved by the 
        FDA. This drug was made specifically for you because your 
        health care provider determined that no FDA-approved product 
        would suit your needs. Serious adverse reactions to this drug 
        should be reported to the FDA at ________________, to the 
        pharmacy where the drug was received, and to your health care 
        provider.' (The blank shall specify a phone number and a Web 
        site, to be provided by the Secretary for purposes of this 
        subsection.); and
            ``(6) such other information as the Secretary may require.
    ``(j) Reporting by Pharmacists and Physicians.--
            ``(1) Adverse event.--If a pharmacist or physician 
        compounding a drug product pursuant to this section becomes 
        aware of any adverse event associated with the use of such 
        product, not later than 10 calendar days after becoming so 
        aware, the pharmacist or physician shall report such adverse 
        event to the Secretary.
            ``(2) Information related to risk of injury or death.--If a 
        pharmacist or physician compounding a drug product pursuant to 
        this section becomes aware of information concerning any 
        bacteriological, fungal, or other contamination; any 
        significant chemical, physical, or other change; or any 
        deterioration of a compounded drug product that has already 
        been distributed by the pharmacist or physician, that could 
        cause serious injury or death, not later than 2 calendar days 
        after becoming so aware, the pharmacist or physician shall 
        report such information to the Secretary.
    ``(k) Compounding Establishment and Reinspection Fees.--
            ``(1) Definitions.--In this subsection--
                    ``(A) the term `affiliate' has the meaning given 
                such term in section 735(11);
                    ``(B) the term `covered compounding pharmacy' means 
                a pharmacy that, pursuant to subsection (d) (the 
                exception to the requirement of an identified 
                individual patient)--
                            ``(i) performs high-risk sterile 
                        compounding;
                            ``(ii) compounds drug products for shipment 
                        across State lines; or
                            ``(iii) otherwise performs compounding 
                        pursuant to subsection (d) that is not 
                        regulated by a State pursuant to a memorandum 
                        of understanding under subsection (d)(4);
                    ``(C) the term `gross annual sales' means the total 
                worldwide gross annual sales, in United States dollars, 
                for a covered compounding pharmacy, including the sales 
                of all the affiliates of the covered compounding 
                pharmacy; and
                    ``(D) the term `reinspection' means, with respect 
                to a covered compounding pharmacy, one 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.
            ``(2) Establishment and reinspection fees.--
                    ``(A) In general.--For fiscal year 2015 and each 
                subsequent fiscal year, the Secretary shall, in 
                accordance with this subsection, assess and collect--
                            ``(i) an annual establishment fee from each 
                        covered compounding pharmacy; and
                            ``(ii) a reinspection fee from each covered 
                        compounding pharmacy subject to a reinspection 
                        in such fiscal year.
                    ``(B) Multiple reinspections.--A covered 
                compounding pharmacy subject to multiple reinspections 
                in a fiscal year shall be subject to a reinspection fee 
                for each reinspection.
            ``(3) Establishment and reinspection fee setting.--The 
        Secretary shall establish the establishment and reinspection 
        fee to be collected under this subsection for each fiscal year, 
        based on the methodology described in paragraph (4) and shall 
        publish such fee in a Federal Register notice not later than 60 
        days before the start of each such year.
            ``(4) Amount of establishment fee and reinspection fee.--
                    ``(A) In general.--For each covered compounding 
                pharmacy in a fiscal year--
                            ``(i) except as provided in subparagraph 
                        (D), the amount of the annual establishment fee 
                        under paragraph (2) shall be equal to the sum 
                        of--
                                    ``(I) $15,000, multiplied by the 
                                inflation adjustment factor described 
                                in subparagraph (B); plus
                                    ``(II) the small business 
                                adjustment factor described in 
                                subparagraph (C); and
                            ``(ii) the amount of any reinspection fee 
                        (if applicable) under paragraph (2) shall be 
                        equal to $15,000, multiplied by the inflation 
                        adjustment factor described in subparagraph 
                        (B).
                    ``(B) Inflation adjustment factor.--
                            ``(i) In general.--For fiscal year 2015 and 
                        subsequent fiscal years, the fee amounts 
                        established in subparagraph (A) 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) one;
                                    ``(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; and
                                    ``(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.
                            ``(ii) Compounded basis.--The adjustment 
                        made each fiscal year under clause (i) shall be 
                        added on a compounded basis to the sum of all 
                        adjustments made each fiscal year after fiscal 
                        year 2014 under clause (i).
                    ``(C) Small business adjustment factor.--The small 
                business adjustment factor referred to subparagraph 
                (A)(i)(II) shall be an amount established by the 
                Secretary for each fiscal year based on the Secretary's 
                estimate of--
                            ``(i) the number of small businesses that 
                        will pay a reduced establishment fee for such 
                        fiscal year; and
                            ``(ii) 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 subparagraph (D).
                    ``(D) Exception for small businesses.--
                            ``(i) In general.--In the case of a covered 
                        compounding pharmacy 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 subsection are assessed, the amount 
                        of the establishment fee under paragraph (2) 
                        for a fiscal year shall be equal to \1/3\ of 
                        the amount calculated under subparagraph 
                        (A)(i)(I) in such fiscal year.
                            ``(ii) Application.--To qualify for the 
                        exception under this subparagraph, 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 must be submitted to the 
                        Secretary not later than April 30 for the 
                        following fiscal year. Any statement or 
                        representation made to the Secretary shall be 
                        subject to section 1001 of title 18, United 
                        States Code.
                    ``(E) Crediting of fees.--In establishing the small 
                business adjustment factor under subparagraph (C) for a 
                fiscal year, the Secretary shall 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 consider the need to account for any 
                adjustment of fees and such other factors as the 
                Secretary determines appropriate.
            ``(5) Use of fees.--The Secretary shall make all of the 
        fees collected pursuant to clauses (i) and (ii) of paragraph 
        (2)(A) available solely to pay for the costs of oversight of 
        covered compounding pharmacies.
            ``(6) Supplement not supplant.--Funds received by the 
        Secretary pursuant to this subsection shall be used to 
        supplement and not supplant any other Federal funds available 
        to carry out the activities described in this section.
            ``(7) Crediting and availability of fees.--Fees authorized 
        under this subsection 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 covered compounding pharmacies.
            ``(8) Collection of fees.--
                    ``(A) Establishment fee.--A covered compounding 
                pharmacy shall remit the establishment fee due under 
                this subsection in a fiscal year when submitting a 
                registration pursuant to subsection (d) for such fiscal 
                year.
                    ``(B) Reinspection fee.--The Secretary shall 
                specify in the Federal Register notice described in 
                paragraph (3) the manner in which reinspection fees 
                assessed under this subsection 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 covered compounding pharmacy 
                involved.
                    ``(C) Effect of failure to pay fees.--
                            ``(i) Registration.--A covered compounding 
                        pharmacy shall not be considered registered 
                        under subsection (d) in a fiscal year until the 
                        date that the covered compounding pharmacy 
                        remits the establishment fee under this 
                        subsection for such fiscal year.
                            ``(ii) Misbranding.--All drugs 
                        manufactured, prepared, propagated, compounded, 
                        or processed by a covered compounding pharmacy 
                        for which any establishment fee or reinspection 
                        fee has not been paid as required by this 
                        subsection shall be deemed misbranded under 
                        section 502(cc) until the fees owed for such 
                        covered compounding pharmacy under this 
                        subsection have been paid.
                    ``(D) Collection of unpaid fees.--In any case where 
                the Secretary does not receive payment of a fee 
                assessed under this subsection within 30 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.
            ``(9) Annual report to congress.--Not later than 120 days 
        after each fiscal year in which fees are assessed and collected 
        under this subsection, the Secretary shall submit a report to 
        the Committee on Energy and Commerce of the House of 
        Representatives and the Committee on Health, Education, Labor, 
        and Pensions of the Senate, to include a description of fees 
        assessed and collected for each year, a summary description of 
        entities paying the fees, and the number of inspections and 
        reinspections of such entities performed each year.
            ``(10) Authorization of appropriations.--For fiscal year 
        2015 and each subsequent fiscal year, there is authorized to be 
        appropriated for fees under this subsection an amount 
        equivalent to the total amount of fees assessed for such fiscal 
        year under this subsection.
    ``(l) Definitions.--In this section:
            ``(1) The terms `compound' and `compounding'--
                    ``(A) do not include mixing, reconstituting, or 
                other such acts that are performed in accordance with 
                directions contained in approved labeling provided by 
                the product's manufacturer and other manufacturer 
                directions consistent with that labeling; and
                    ``(B) in the case of a radioactive drug (as defined 
                in section 310.3(n) of title 21, Code of Federal 
                Regulations (or any successor regulations)), also do 
                not include a minor deviation from such directions with 
                regard to radioactivity, volume, or stability, that is 
                made by or under the direct supervision of an 
                `authorized nuclear pharmacist' or a physician who is 
                an `authorized user' (as such terms are defined in 
                section 35.2 of title 10, Code of Federal Regulations, 
                (or any successor regulations)).
            ``(2) The term `copy of a commercially available drug 
        product' does not include a drug product in which there is a 
        change, made for an identified individual patient, which 
        produces for that patient a significant difference, as 
        determined by the prescribing practitioner, between the 
        compounded drug and the comparable commercially available drug 
        product, provided that in the case of a radioactive drug (as 
        defined in section 310.3(n) of title 21, Code of Federal 
        Regulations (or any successor regulations)), the reasons for 
        the determination by the prescribing practitioner have been 
        documented and such documentation is maintained by the 
        pharmacy.
            ``(3) The term `high-risk sterile compounding' means 
        compounding sterile drug products using nonsterile ingredients, 
        nonsterile devices, or nonsterile components.''.
    (b) 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:
    ``(bb) If it is a drug product compounded pursuant to section 503A 
and its labeling does not include the information required by section 
503A(i).
    ``(cc) If it is a drug, and it was manufactured, prepared, 
propagated, compounded, or processed by a compounding manufacturer for 
which fees have not been paid as required by section 503A(k).''.
    (c) Conforming Amendment.--Section 704(a)(2)(A) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 374(a)(2)(A)) is amended by 
inserting ``subject to section 503A,'' before ``pharmacies which 
maintain establishments''.
    (d) Regulations.--Not later than 1 year after the date of the 
enactment of this Act, the Secretary shall promulgate final regulations 
for carrying out the amendments made by subsections (a), (b), and (c).
    (e) Effective Date.--The amendments made by subsections (a), (b), 
and (c) shall take effect on the date that is 1 year after the date of 
the enactment of this Act.

SEC. 3. REGISTRATION OF MANUFACTURERS COMPOUNDING DRUG PRODUCTS.

    (a) Registration.--Section 510(g) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360(g)) is amended by adding at the end the 
following: ``With respect to compounding drugs, the exemption in 
paragraph (1) does not apply with respect to any pharmacy to the extent 
to which the pharmacy is, in effect, manufacturing such drugs, as 
determined by the Secretary, taking into consideration the extent to 
which such pharmacy sells the drugs across State lines, the quantity of 
the drugs sold, and any other factors determined appropriate by the 
Secretary.''.
    (b) Regulations.--Not later than 1 year after the date of the 
enactment of this Act, the Secretary of Health and Human Services shall 
promulgate regulations for carrying out the amendment made by 
subsection (a).
    (c) Effective Date.--The amendment made by subsection (a) shall 
take effect on the date that is 1 year after the date of the enactment 
of this Act.

SEC. 4. NO PREEMPTION OF ADDITIONAL NON-FEDERAL REQUIREMENTS.

    The requirements of this Act (including the requirements of the 
amendments made by this Act) do not preempt any non-Federal requirement 
that is in addition to, and compatible with, such requirements.
                                 <all>
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