(a) The manufacturer of a drug product for which a Medication Guide is required under this part shall obtain FDA approval of the Medication Guide before the Medication Guide may be distributed.
(b) Each manufacturer who ships a container of drug product for which a Medication Guide is required under this part is responsible for ensuring that Medication Guides are available for distribution to patients by either:
(1) Providing Medication Guides in sufficient numbers to distributors, packers, or authorized dispensers to permit the authorized dispenser to provide a Medication Guide to each patient receiving a prescription for the drug product; or
(2) Providing the means to produce Medication Guides in sufficient numbers to distributors, packers, or authorized dispensers to permit the authorized dispenser to provide a Medication Guide to each patient receiving a prescription for the drug product.
(c) Each distributor or packer that receives Medication Guides, or the means to produce Medication Guides, from a manufacturer under paragraph (b) of this section shall provide those Medication Guides, or the means to produce Medication Guides, to each authorized dispenser to whom it ships a container of drug product.
(d) The label of each container or package, where the container label is too small, of drug product for which a Medication Guide is required under this part shall instruct the authorized dispenser to provide a Medication Guide to each patient to whom the drug product is dispensed, and shall state how the Medication Guide is provided. These statements shall appear on the label in a prominent and conspicuous manner.
(e) Each authorized dispenser of a prescription drug product for which a Medication Guide is required under this part shall, when the product is dispensed to a patient (or to a patient's agent), provide a Medication Guide directly to each patient (or to the patient's agent) unless an exemption applies under § 208.26.
(f) An authorized dispenser or wholesaler is not subject to section 510 of the Federal Food, Drug, and Cosmetic Act, which requires the registration of producers of drugs and the listing of drugs in commercial distribution, solely because of an act performed by the authorized dispenser or wholesaler under this part.
Notes of Decisions
Rita McDaniel v. Upsher-Smith Labs., Inc., 893 F.3d 941 (6th Cir. 2018).
· cites it 6× “21 C.F.R. § 208.24 (b). Medication Guides explain the approved uses of a drug and its side effects to a patient “in nontechnical, understandable language” that is clearly presented in at least 10-point font.”
Moore v. Zydus Pharm. (USA), Inc., 277 F. Supp. 3d 873 (E.D. Ky. 2017).
· cites it 4× “” 21 C.F.R. § 208.24 . But, at the time a prescription drug is dispensed, it is the pharmacy (or authorized dispenser) that must “provide a Medication Guide directly to each patient,” not the manufacturer of the drug.”
Small v. Amgen, Inc., 134 F. Supp. 3d 1358 (M.D. Fla. 2015).
· cites it 3× “Alternatively, plaintiffs argue that the learned intermediary doctrine is pre-empted by 21 C.F.R. § 208.24 , and that defendants’ motion for summary judgment should be denied because there are disputed issues of material fact.”
Martinez v. Pfizer Inc., 388 F. Supp. 3d 748 (W.D. Tex. 2019).
“With respect to Fort Duncan's direct liability, Plaintiffs assert that Fort Duncan failed to adequately train its staff, failed to have or enforce adequate policies and procedures, and failed to provide Martinez a medication guide as required by 21 C.F.R. § 208.24 . As a result…”
Stephens v. Teva Pharm., U.S.A., Inc., 70 F. Supp. 3d 1246 (N.D. Ala. 2014).
· cites it 3× “Without a well-founded allegation that *1250 Hunstville Hospital Pharmacy failed to provide a Medication Guide to plaintiff because defendants did not supply the Guide to the pharmacy along with the medication, as required by 21 C.F.R. § 208.24 , this claim cannot survive.”
Perdue v. Wyeth Pharm., Inc., 209 F. Supp. 3d 847 (E.D.N.C. 2016).
“¶45 (citing 21 C.F.R. § 208.24 )). The failure to provide each patient a ‘Medication Guide’ by failing to provide the Medication Guides to the distributor for ultimate distribution to the patient with the drug is a direct violation of the FDA’s mandate to the manufacturers of…”
McDaniel v. Upsher-Smith Pharm., Inc., 229 F. Supp. 3d 707 (W.D. Tenn. 2017).
· cites it 3× “Failure to Warn The requirement to provide a medication guide is found in the Food, Drug and Cosmetic Act (FDCA), 21 C.F.R. § 208.24 . (Compl. at 12-14, ECF No.”
Cross v. Forest Labs., 102 F. Supp. 3d 896 (N.D. Miss. 2015).
“Forest also argues that- the FDA would have rejected a proposed warning about the link between SSRIs and suicidality in adults because the FDA has not found a clear causal link between the two.”
Phyllis Bennett v. Teva Pharm. USA Inc (3rd Cir. 2022).
· cites it 5× “21 C.F.R. § 208.24 (b).1 In turn, distributors or packers must provide those guides or the means to produce them to authorized dispensers.”
Roncal v. Aurobindo Pharma USA, Inc. (D.N.J. 2022).
· cites it 5× “20 (a)(1), (b)(2), and be provided to patients or their agents barring an applicable exception, see 21 C.F.R. § 208.24 . Like other manufacturers, Aurobindo is required to ensure that Medication Guides are available for distribution to patients prescribed Amiodarone.”
Jankowski v. Zydus Pharm. USA, Inc. (D.N.J. 2021).
· cites it 3× “| 179; see 21 C.F.R. § 208.24 (2020).) According to Plaintiffs, Zydus failed to provide, or make available for distribution, the FDA-required Medication Guide to both distributors and patients.”
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