Drug products that have been subjected to improper storage conditions including extremes in temperature, humidity, smoke, fumes, pressure, age, or radiation due to natural disasters, fires, accidents, or equipment failures shall not be salvaged and returned to the marketplace. Whenever there is a question whether drug products have been subjected to such conditions, salvaging operations may be conducted only if there is (a) evidence from laboratory tests and assays (including animal feeding studies where applicable) that the drug products meet all applicable standards of identity, strength, quality, and purity and (b) evidence from inspection of the premises that the drug products and their associated packaging were not subjected to improper storage conditions as a result of the disaster or accident. Organoleptic examinations shall be acceptable only as supplemental evidence that the drug products meet appropriate standards of identity, strength, quality, and purity. Records including name, lot number, and disposition shall be maintained for drug products subject to this section.
Notes of Decisions
Am. Home Assur. Co. v. Merck & Co., Inc., 386 F. Supp. 2d 501 (S.D.N.Y. 2005).
· cites it 6× “Merck claimed that the goods could not be sold pursuant to its reasonable interpretation of an FDA regulation, 21 C.F.R. § 211.208 (“Section 211.208”), which states in its entirety as follows: Drug products that have been subjected to improper storage conditions including…”
Eli Lilly & Co. v. Air Express Int'l USA, Inc., 615 F.3d 1305 (11th Cir. 2010).
“21 C.F.R. § 211.208 . And, Plaintiffs presented uncontradicted expert testimony that any testing of insulin subjected to sub-freezing temperatures would result in destruction of the insulin.”
Am. Home Assurance Co. v. Merck & Co., Inc., 462 F. Supp. 2d 435 (S.D.N.Y. 2006).
“Second, and interrelated, is that American Home has understood it to be Merck’s position throughout the course of this litigation that 21 C.F.R. § 211.208 (“Section 211.208”) is the applicable regulation on which Merck relied in deeming the goods unfit.”
Eli Lilly & Co. v. Air Express Int'l USA, Inc., 602 F. Supp. 2d 1260 (S.D. Fla. 2009).
“Third, Plaintiffs point to 21 C.F.R. § 211.208 , drug product salvaging, which provides in relevant part: Drug products that have been subjected to improper storage conditions including extremes in temperature, humidity, smoke, fumes, pressure, age, or radiation due to natural…”
Annotations are extracted automatically from the opinions in the
Syfert caselaw corpus and ranked by authority, recency, and
treatment. Dots show Syfertize treatment of the citing case itself.