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U.S. Code as of:
01/19/04
Section 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.
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