…Love Affair with Cheap Drugs has a Hidden Cost,” “How a Tainted Heart Drug Made in China Slipped Past the FDA,” and “Culture of ‘Bending Rules’ in India Challenges U.S….

…“color” for the opening and closing presentations. It’s understandable that Lilly would create an ad with three separate components that had flexible uses. Creating TV commercials ain’t cheap nor is…

…for removal of the patent information from the Orange Book; and then there’s that crazy guy who summited Mt. Kilimanjaro in Tanzania, Africa with the Orange Book (here).  For all…

…leader, donates product to the doctor which the doctor takes overseas to treat sleeping sickness in Africa. Or donates products to a surgeon to fix cleft palates in Ukraine. In…

…down from the summit of Mt. Kilimanjaro in Tanzania, Africa.  And while we were at the summit (Uhuru Peak, at 19,341 feet), we staked a claim for Hyman, Phelps &…

“The Constant Gardener,” a 2001 novel and 2005 movie, revolves in part around an ethically questionable drug trial a foreign drug company conducts in Africa.  Real life events have also…

…to transfer, store, convert formats, or display electronic patient records that are the equivalent of a paper medical chart are not devices if all the following criteria are met: Such…

…letter stated that requiring such information on foods served in grocery stores “would place a disproportionate cost on grocery store chains . . . because grocery store chains lack the…

…of distribution.  See prior post, here.  These costs include compliance with the physical security requirements imposed on registrants for Schedule II controlled substances (i.e., that they be physically stored in…

…and (C) “to serve as electronic patient records, including patient-provided information, to the extent that such records are intended to transfer, store, convert formats, or display the equivalent of a…

…to DEA based on the quantity of kilograms involved. 1318.06(b)(1). DEA sells cannabis to the buyer at the negotiated sale price plus the assessed administrative fee. The buyer pays the…

…provide inventory services to retail stores, including pharmacies, throughout the U.S. The press release notes that the companies’ policies touted that “only handpicked, high-caliber, well-respected employees are assigned to pharmacy…

…of all parties, including those of managed care pharmacy, are taken into consideration.”  Letter from Edith A. Rosato, RPh, Academy of Managed Care Pharmacy, to Tom Frieden, CDC, (Sept. 18,…

…owns and controls the hospital pharmacy and that are located within a 1 mile radius of the compounding pharmacy; (2) The drug products are only administered within the healthcare facilities…

…ephedrine and phenylpropanolamine. “Regulated sellers” (retail distributors including pharmacies, grocery stores, general merchandise stores and mobile vendors) selling “scheduled listed chemical products” (“SCLPs”) (products containing ephedrine, PSE and phenylpropanolamine that…