Source: http://www.law.cornell.edu/uscode/text/21/353a?qt-us_code_tabs=0
Timestamp: 2014-07-29 13:11:13
Document Index: 206687970

Matched Legal Cases: ['§ 353', '§ 353', '§ 353', '§ 503', '§ 127', '§ 106', '§ 106', '§ 106', '§ 106', '§ 127', '§ 353', 'art 5', 'art 7', 'art 10', 'art 11', 'art 12', 'art 13', 'art 14', 'art 15', 'art 16', 'art 20', 'art 25', 'art 216']

21 U.S. Code § 353a - Pharmacy compounding | LII / Legal Information Institute
U.S. Code › Title 21 › Chapter 9 › Subchapter V › Part A › § 353a 21 U.S. Code § 353a - Pharmacy compounding
(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 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—
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 (c) of this section;
(June 25, 1938, ch. 675, § 503A, as added Pub. L. 105–115, title I, § 127(a),Nov. 21, 1997, 111 Stat. 2328; amended Pub. L. 113–54, title I, § 106(a),Nov. 27, 2013, 127 Stat. 598.)
2013—Subsec. (a). Pub. L. 113–54, § 106(a)(1), struck out “unsolicited” before “receipt of a valid prescription” in introductory provisions.
Subsec. (b)(1)(A)(i)(III). Pub. L. 113–54, § 106(a)(4), substituted “subsection (c)” for “subsection (d)”.
Subsec. (c) to (e). Pub. L. 113–54, § 106(a)(2), (3), redesignatedsubsecs. (d) to (f) as (c) to (e), respectively, and struck out former subsec. (c). Prior to amendment, subsec. (c) read as follows: “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.”
Pub. L. 105–115, title I, § 127(b),Nov. 21, 1997, 111 Stat. 2330, 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].”
21 USCDescription of ChangeSession YearPublic LawStatutes at Large § 353a2013113-54 [Sec.] 106(a)127 Stat. 598 This is a list of parts within the Code of Federal Regulations for which this US Code section provides rulemaking authority.This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.21 CFR - Food and Drugs21 CFR Part 5 - ORGANIZATION21 CFR Part 7 - ENFORCEMENT POLICY21 CFR Part 10 - ADMINISTRATIVE PRACTICES AND PROCEDURES21 CFR Part 11 - ELECTRONIC RECORDS; ELECTRONIC SIGNATURES21 CFR Part 12 - FORMAL EVIDENTIARY PUBLIC HEARING21 CFR Part 13 - PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY21 CFR Part 14 - PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE21 CFR Part 15 - PUBLIC HEARING BEFORE THE COMMISSIONER21 CFR Part 16 - REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION21 CFR Part 20 - PUBLIC INFORMATION21 CFR Part 25 - ENVIRONMENTAL IMPACT CONSIDERATIONS21 CFR Part 216 - PHARMACY COMPOUNDING