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SEC. 127. APPLICATION OF FEDERAL LAW TO PRACTICE OF PHARMACY
COMPOUNDING
(a) Amendment.--Chapter V is amended by inserting after section 503 (21 U.S.C.
353) the following:
"SEC. 503A. PHARMACY COMPOUNDING.
"(a) In General.--Sections 501(a)(2)(B), 502(f)(1), and 505 shall not apply to a
drug product if the drug product is compounded for an 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) 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;
"(ll) 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);
"(ii) that are manufactured by an establishment that is registered under section 510 (including a foreign establishment that is registered under section 510(i)); 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)
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.
[Section (c) pertaining to advertising and promotion has been rendered
unconstitutional and therefore unenforceable by Western States Medical Center,
et al. v. Donna Shalala, et al., U.S. District Court of Nevada, September 16,
1999.]
"(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), 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) 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 201(ii); or
"(2) radiopharmaceuticals.
"(f) Definition.--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."
(b) Effective Date.--Section 503A of the Federal Food, Drug and Cosmetic Act, 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
(The Legislative History of the Compounding Section of FDAMA )
HOUSE/SENATE CONFERENCE REPORT (HOUSE REPORT 105-399)
The conference report includes provisions on pharmacy compounding that reflect the conferees' extensive work with the Food and Drug Administration and other interested parties to reach consensus. It is the intent of the conferees to ensure continued availability of compounded drug products as a component of individualized therapy, while limiting the scope of compounding so as to prevent manufacturing under the guise of compounding. Section 503A establishes parameters under which compounding is appropriate and lawful. The conditions set forth in Section 503A :should be used by the state boards of pharmacy and medicine for proper regulation of pharmacy compounding in addition to existing state-specific regulations.
The conferees intend that, as defined in subparagraph (b)(2), copies of commercially available drug products do not include drug products in which the change from the commercially available drug product that produces a 'significant difference' for the particular patient. For example, the removal of a dye from a commercially available drug product for a particular patient who is allergic to such dye shall be presumed to be a 'significant difference.' The conferees expect that FDA and the courts will accord great deference to the licensed prescriber's judgment in determining whether the change produces a 'significant difference.' However, where it is readily apparent, based on the circumstances, the 'significant difference' is a mere pretext to allow compounding of products that are essentially copies of commercially available products, such compounding would be considered copying of commercially available products and would not qualify for the compounding exemptions if it is done regularly or in inordinate amounts.
The conferees also expect that the Secretary will develop the list of bulk drug substances described in subsection (b)(1)(A)(i)(III) within one year from the date of enactment. It is the intent of the conferees that the criteria used to develop the list of bulk drug substances and the list itself are to be developed in consultation with the United States Pharmacopoeia. The conferees further intend that where evidence relating to an approval under Section 505 does not exist, the Secretary shall consider other criteria. Finally, the conferees intend that after this list is published, organizations may petition the FDA for inclusion of additional substances on the aforementioned list.
The memorandum of understanding described in Paragraph (b)(3)(B)(i) shall provide guidance on the meaning of inordinate amounts, including any circumstances under which the compounding of drug products for interstate shipment in excess of 5 percent of total prescription orders would be included in a 'safe harbor' of interstate shipments of compounded products that shall not be deemed inordinate.
As stated in paragraph (e), nothing in Section 503A is intended to change or otherwise affect current law with respect to radiopharmaceuticals, including PET drugs. Further, as stated in paragraph (f), 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. Nothing in this provision is intended to change or otherwise affect the Act with respect to reconstitution or other similar processing that is done pursuant to a manufacturer's approved labeling, and other directions from such manufacturer that are consistent with that labeling. In general, such practices, as performed by a licensed practitioner for an identified individual patient, are appropriately regulated by state boards of pharmacy. The conferees intend that facilities required to register with FDA, including those which are engaged in non-patient specific compounding and reconstitution activities, are appropriately regulated under the Federal Food, Drug and Cosmetic Act.
Finally, with regard to the effective date described in paragraph (b), the conferees expect the FDA to work diligently to consult with necessary parties to promulgate the required regulations and lists. Nothing in paragraph (b) is intended to abrogate the Secretary's responsibility to promulgate such regulations through the notice and comment rulemaking process.
EXCERPTS FROM SENATE LABOR AND HUMAN RESOURCES COMMITTEE REPORT (S. Rpt. 105-43)
Pharmacy compounding
Section 809 of S. 830 is intended to clarify the application of the Federal Food, Drug and Cosmetic Act to the professional practice of pharmacist compounding of drug products. States currently have the authority to license pharmacists and regulate pharmacies, including the scope of pharmacy practice. All States include compounding as a core component of the profession of pharmacy. While the Food, Drug and Cosmetic Act specifically exempts pharmacies from inspection and registration provisions of the Act, it has been the contention of the Food and Drug Administration that compounded products are not exempt from the Act's new drug provisions. The committee has found that clarification is necessary to address current concerns and uncertainty about the Food and Drug Administration's regulatory authority over pharmacy compounding.
Section 809 establishes parameters under which compounding is appropriate and lawful. This section is not intended to subvert the requirements that apply to investigational new drugs or to result in experimentation without appropriate human subject protections, including proper informed consent.
The views of the Committee with respect to certain subsections of Section 809 are outlined below:
Implementation of [subsection (b)(l)(A)], regarding bulk drug substances, is expected to coincide with the implementation of [subsection (d)], except that compliance with the standards of an applicable United States Pharmacopoeia monograph is not dependent on any further implementation under [subsection (d)].
Among other requirements, a bulk drug substance used for compounding must have been manufactured in an establishment that has registered under section 510 of the Act. In addition to applying to domestic manufacturing establishments, this requirement shall also apply to foreign establishments, once the requirement in [section 417] of this Act, which requires foreign establishments to register and list under section 510 of the Act, becomes effective.
In compliance with [subsection (b)(1)(A)(iii)], pharmacists may retain each certificate of analysis until the supply of such bulk drug substance has been exhausted, and must record in the compounding record the manufacturer, repackager (if any), and the lot number of the bulk drug substance.
The list published pursuant to [subsection (b)(1)(C)] includes drug products that have been withdrawn or removed from the market because the finished drug product and/or a component thereof has been found to be unsafe or not effective. The Federal Register document that includes the list should briefly describe the basis for the withdrawal or removal and provide interested parties with an opportunity to comment. The list should not include products that have been withdrawn or removed solely because of manufacturing issues.
Interested parties should be allowed to petition, under 21 CFR Sec. 10.30, to change the listing of a particular drug product under [subsection (b)(3)(A)] should research and technology yield advances which correct the compounding difficulties.
The Food And Drug Administration Modernization Act International Academy of Compounding Pharmacists