
From the U.S. Code Online via GPO Access
[wais.access.gpo.gov]
[Laws in effect as of January 2, 2001]
[Document not affected by Public Laws enacted between
  January 2, 2001 and January 28, 2002]
[CITE: 21USC353a]

 
                        TITLE 21--FOOD AND DRUGS
 
             CHAPTER 9--FEDERAL FOOD, DRUG, AND COSMETIC ACT
 
                     SUBCHAPTER V--DRUGS AND DEVICES
 
                        Part A--Drugs and Devices
 
Sec. 353a. Pharmacy compounding


(a) In general

    Sections 351(a)(2)(B), 352(f)(1), and 355 of this title shall not 
apply to a drug product if the drug product is compounded for an 
identified individual patient based on the unsolicited receipt of a 
valid prescription order or a notation, approved by the prescribing 
practitioner, on the prescription order that a compounded product is 
necessary for the identified patient, if the drug product meets the 
requirements of this section, and if the compounding--
        (1) is by--
            (A) a licensed pharmacist in a State licensed pharmacy or a 
        Federal facility, or
            (B) a licensed physician,

    on the prescription order for such individual patient made by a 
    licensed physician or other licensed practitioner authorized by 
    State law to prescribe drugs; or
        (2)(A) is by a licensed pharmacist or licensed physician in 
    limited quantities before the receipt of a valid prescription order 
    for such individual patient; and
        (B) is based on a history of the licensed pharmacist or licensed 
    physician receiving valid prescription orders for the compounding of 
    the drug product, which orders have been generated solely within an 
    established relationship between--
            (i) the licensed pharmacist or licensed physician; and
            (ii)(I) such individual patient for whom the prescription 
        order will be provided; or
            (II) the physician or other licensed practitioner who will 
        write such prescription order.

(b) Compounded drug

           (1) Licensed pharmacist and licensed physician

        A drug product may be compounded under subsection (a) of this 
    section if the licensed pharmacist or licensed physician--
            (A) compounds the drug product using bulk drug substances, 
        as defined in regulations of the Secretary published at section 
        207.3(a)(4) of title 21 of the Code of Federal Regulations--
                (i) that--
                    (I) comply with the standards of an applicable 
                United States Pharmacopoeia or National Formulary 
                monograph, if a monograph exists, and the United States 
                Pharmacopoeia chapter on pharmacy compounding;
                    (II) if such a monograph does not exist, are drug 
                substances that are components of drugs approved by the 
                Secretary; or
                    (III) if such a monograph does not exist and the 
                drug substance is not a component of a drug approved by 
                the Secretary, that appear on a list developed by the 
                Secretary through regulations issued by the Secretary 
                under subsection (d) of this section;

                (ii) that are manufactured by an establishment that is 
            registered under section 360 of this title (including a 
            foreign establishment that is registered under section 
            360(i) of this title); and
                (iii) that are accompanied by valid certificates of 
            analysis for each bulk drug substance;

            (B) compounds the drug product using ingredients (other than 
        bulk drug substances) that comply with the standards of an 
        applicable United States Pharmacopoeia or National Formulary 
        monograph, if a monograph exists, and the United States 
        Pharmacopoeia chapter on pharmacy compounding;
            (C) does not compound a drug product that appears on a list 
        published by the Secretary in the Federal Register of drug 
        products that have been withdrawn or removed from the market 
        because such drug products or components of such drug products 
        have been found to be unsafe or not effective; and
            (D) does not compound regularly or in inordinate amounts (as 
        defined by the Secretary) any drug products that are essentially 
        copies of a commercially available drug product.

                           (2) Definition

        For purposes of paragraph (1)(D), the term ``essentially a 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.

                          (3) Drug product

        A drug product may be compounded under subsection (a) only if--
            (A) such drug product is not a drug product identified by 
        the Secretary by regulation as a drug product that presents 
        demonstrable difficulties for compounding that reasonably 
        demonstrate an adverse effect on the safety or effectiveness of 
        that drug product; and
            (B) such drug product is compounded in a State--
                (i) that has entered into a memorandum of understanding 
            with the Secretary which addresses the distribution of 
            inordinate amounts of compounded drug products interstate 
            and provides for appropriate investigation by a State agency 
            of complaints relating to compounded drug products 
            distributed outside such State; or
                (ii) that has not entered into the memorandum of 
            understanding described in clause (i) and the licensed 
            pharmacist, licensed pharmacy, or licensed physician 
            distributes (or causes to be distributed) compounded drug 
            products out of the State in which they are compounded in 
            quantities that do not exceed 5 percent of the total 
            prescription orders dispensed or distributed by such 
            pharmacy or physician.

    The Secretary shall, in consultation with the National Association 
    of Boards of Pharmacy, develop a standard memorandum of 
    understanding for use by the States in complying with subparagraph 
    (B)(i).

(c) Advertising and promotion

    A drug may be compounded under subsection (a) of this section only 
if the pharmacy, licensed pharmacist, or licensed physician does not 
advertise or promote the compounding of any particular drug, class of 
drug, or type of drug. The pharmacy, licensed pharmacist, or licensed 
physician may advertise and promote the compounding service provided by 
the licensed pharmacist or licensed physician.

(d) Regulations

                           (1) In general

        The Secretary shall issue regulations to implement this section. 
    Before issuing regulations to implement subsections 
    (b)(1)(A)(i)(III), (b)(1)(C), or (b)(3)(A) of this section, the 
    Secretary shall convene and consult an advisory committee on 
    compounding unless the Secretary determines that the issuance of 
    such regulations before consultation is necessary to protect the 
    public health. The advisory committee shall include representatives 
    from the National Association of Boards of Pharmacy, the United 
    States Pharmacopoeia, pharmacy, physician, and consumer 
    organizations, and other experts selected by the Secretary.

                      (2) Limiting compounding

        The Secretary, in consultation with the United States 
    Pharmacopoeia Convention, Incorporated, shall promulgate regulations 
    identifying drug substances that may be used in compounding under 
    subsection (b)(1)(A)(i)(III) of this section for which a monograph 
    does not exist or which are not components of drug products approved 
    by the Secretary. The Secretary shall include in the regulation the 
    criteria for such substances, which shall include historical use, 
    reports in peer reviewed medical literature, or other criteria the 
    Secretary may identify.

(e) Application

    This section shall not apply to--
        (1) compounded positron emission tomography drugs as defined in 
    section 321(ii) of this title; or
        (2) radiopharmaceuticals.

(f) ``Compounding'' defined

    As used in this section, the term ``compounding'' does 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.

(June 25, 1938, ch. 675, Sec. 503A, as added Pub. L. 105-115, title I, 
Sec. 127(a), Nov. 21, 1997, 111 Stat. 2328.)


                             Effective Date

    Section 127(b) of Pub. L. 105-115 provided that: ``Section 503A of 
the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 353a], added by 
subsection (a), shall take effect upon the expiration of the 1-year 
period beginning on the date of the enactment of this Act [Nov. 21, 
1997].''
