(a) This part sets forth requirements for patient labeling for human prescription drug products, including biological products, that the Food and Drug Administration (FDA) determines pose a serious and significant public health concern requiring distribution of FDA-approved patient information. It applies primarily to human prescription drug products used on an outpatient basis without direct supervision by a health professional. This part shall apply to new prescriptions and refill prescriptions.
(b) The purpose of patient labeling for human prescription drug products required under this part is to provide information when the FDA determines in writing that it is necessary to patients' safe and effective use of drug products.
(c) Patient labeling will be required if the FDA determines that one or more of the following circumstances exists:
(1) The drug product is one for which patient labeling could help prevent serious adverse effects.
(2) The drug product is one that has serious risk(s) (relative to benefits) of which patients should be made aware because information concerning the risk(s) could affect patients' decision to use, or to continue to use, the product.
(3) The drug product is important to health and patient adherence to directions for use is crucial to the drug's effectiveness.
Notes of Decisions
Utts v. Bristol-Myers Squibb Co., 251 F. Supp. 3d 644 (S.D.N.Y. 2017).
“21 C.F.R. § 208.1 (c). The purpose of patient labeling is “to provide information when the FDA determines in writing that it is necessary to patients’ safe and effective use of drug products.”
Small v. Amgen, Inc., 134 F. Supp. 3d 1358 (M.D. Fla. 2015).
· cites it 2× “” 21 C.F.R. § 208.1 (a). Patient labeling, also known as a medication guide, is required when the FDA determines that the “patient labeling could help prevent serious adverse effects;” the safety information regarding the drug’s “serious risk(s) (relative to benefits) .”
Frazier v. Mylan Inc., 911 F. Supp. 2d 1285 (N.D. Ga. 2012).
“See 21 C.F.R. §§ 208.1 (c), 208.24(a). Third, the learned intermediary doctrine would still bar plaintiffs claim because it only requires a duty to warn the physician.”
Moore v. Zydus Pharm. (USA), Inc., 277 F. Supp. 3d 873 (E.D. Ky. 2017).
“21 C.F.R. § 208.1 . In December 2004, the FDA determined that Cordarone must be accompanied by a medication guide.”
Bartlett v. Mut. Pharm., 2010 DNH 164 (D.N.H. 2010).
· cites it 2× “The FDA also reguired that all NSAIDs be accompanied by a patient medication guide, see 21 C.F.R. § 208.1 , with an express warning of "life- threatening skin reactions" and an instruction that patients should stop taking the drug if they experienced "skin rash or blisters with…”
Amiodarone Cases (Cal. Ct. App. 2022).
· cites it 2× “( 21 C.F.R. § 208.1 (b) & (c).) According to the FDA website, “Medication Guides are paper handouts that come with many prescription medicines.”
Rebecca A. Small v. AMGEN, Inc. (11th Cir. 2018).
“” 21 C.F.R. 208.1(b). Mrs. Small contends that the FDA medication guide regulations preempt Florida’s learned intermediary doctrine.”
Cook v. Wyeth Pharm., Inc (N.D. Ala. 2020).
“]” 21 C.F.R. § 208.1 (c). In those situations, a manufacturer must ensure “that Medication Guides are available for distribution to patients by either: (1) Providing Medication Guides in sufficient numbers to distributors, packers, or authorized dispensers .”
Roncal v. Aurobindo Pharma USA, Inc. (D.N.J. 2022).
“See SAC ¶¶ 1-16 (subparagraph b), 44, 51; 21 C.F.R. §§ 208.1 , 208.24. Plaintiffs allege that Aurobindo failed to: (1) provide Medication Guides to Plaintiffs, see, e.”
— 21 C.F.R. § 208.1(b) — 1 case
Rebecca A. Small v. AMGEN, Inc. (11th Cir. 2018).
“” 21 C.F.R. 208.1(b). Mrs. Small contends that the FDA medication guide regulations preempt Florida’s learned intermediary doctrine.”
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