2011 Louisiana Laws
Revised Statutes
TITLE 37 — Professions and occupations
RS 37:3474 — Manufacturer distribution of legend drugs and legend devices
§3474. Manufacturer distribution of legend drugs and legend devices
A. For the purposes of this Section, the following terms shall have the following meanings:
(1) "Co-licensed partner" means a person in a relationship in which two or more persons have the right to engage in the manufacturing or marketing of a legend drug or legend device.
(2) "Pre-market notification 510(k)" or "510(k)" means the process by which a legend device manufacturer seeks regulatory clearance for any new or substantially changed device prior to marketing.
B. Legend drug manufacturers and co-licensed partners of legend drug manufacturers who meet the following criteria shall satisfy the requirements of R.S. 37:3469(A), 3470, and 3473:
(1) Have an approved new drug application from the United States Food and Drug Administration (FDA).
(2) Have an establishment registration issued by the FDA pursuant to 21 CFR Part 207 and meet the requirements of 21 CFR Part 205.
(3) Distribute only FDA-approved legend drugs for which the legend drug manufacturer holds an approved new drug application or use a contracted third-party logistics provider to distribute only FDA-approved legend drugs for which the legend drug manufacturer holds an approved new drug application.
C. Legend device manufacturers and co-licensed partners of legend device manufacturers who meet the following criteria shall satisfy the requirements of R.S. 37:3469(A), 3470, and 3473:
(1) Have a 510(k) approved by the FDA.
(2) Have an establishment registration issued by the FDA pursuant to 21 CFR Part 807 and meet the requirements of 21 CFR Part 801.
(3) Distribute only FDA-approved 510(k) legend devices for which the legend device manufacturer holds an approved 510(k) or use a contracted third-party logistics provider to distribute only FDA-approved 510(k) legend devices for which the legend device manufacturer holds an approved 510(k).
Acts 2008, No. 597, §1.
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