Changes

1,250 bytes added , 20:52, July 15, 2023

no edit summary

Line 8: Line 8:

*42 U.S.C. § 262 (relating to approved biologics license applications ("BLAs") filed with FDA for treatments)

+

Other related statutes:

+

*21 U.S.C. § 360(b), (g)(2) (exempting from the requirement that drug manufacturers register with FDA licensed practitioners “who manufacture, prepare, propagate, compound, or process drugs or devices solely for use in the course of their professional practice”)

+

*21 U.S.C. § 374(a)(2)(B) (narrowing FDA’s ability to review records when inspecting licensed practitioners “who manufacture, prepare, propagate, compound, or process drugs[] . . . solely for use in the course of their professional practice”).

+

*21 U.S.C. § 396 (the only provision in the FDCA headed by the “Practice of Medicine,” which relates to medical devices rather than drugs).

+

21 U.S.C. §§ 360(k), 360e—so-called “off label” prescriptions: “[n]othing in this

+

[Act] shall be construed to limit or interfere with the authority of a health care

+

practitioner to prescribe or administer any legally marketed device to a patient for any

+

condition or disease within a legitimate health care practitioner-patient relationship.”

+

Id. § 396.

+

The FDCA applies even to drugs made on an individual basis, such as drugs that are “compounded” by a pharmacy or physician “for an identified individual patient.” 21 U.S.C. § 353a.

+

== See also ==

*[[Stem cell decisions]]

[[category:stem cells]]

Aschlafly

Anthony, Irenaeus, Siteadmin, apieditor, Bureaucrats, Check users, nsAm_Govt_101RO, nsAm_Govt_101RW, nsAm_Govt_101_ta, nsJudgesRO, nsJudgesRW, nsJudges_talkRO, nsJudges_talkRW, nsTeam2RO, nsTeam2RW, nsTeam2_talkRO, nsTeam2_talkRW, oversight, Administrators

126,597

edits

Changes

Stem cell statutes (view source)

Revision as of 20:52, July 15, 2023