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…shortages, FDA intends to allow the public and prescribers to develop alternative treatment plans before learning a prescription cannot be filled at the pharmacy when there is a supply issue….
…certain rigorous conditions are met. Now, comes the second. Isomeric Pharmacy Solutions, LLC and three affiliated individuals (all Defendants in the matter) signed a Consent Decree that was entered in…
…as consumers of these products, we are thankful for that. FDA inspected the NIH Pharmaceutical Development Section and Clinical Center Pharmacy for five days between May 19 and May 29,…
…that were originally intended to be included in the mega-rule – i.e., the definition of an eligible patient; compliance requirements for contract pharmacy arrangements; hospital eligibility criteria; and eligibility of…
…and were forced to cease production. A recall by manufacturer Mallinckrodt and cutbacks by Ethex have also purportedly contributed to the problem. One pharmacy expert observed that a few years…
…discretion,” and instead initiate enforcement action against a compounding pharmacy. In early November, the government appealed that decision to the U.S. Court of Appeals for the Eleventh Circuit. Ms. Palmer…
…FDAer) has stated that it is confident in its generic anti-epileptic drug approvals (a sentiment that has been echoed by the Academy of Managed Care Pharmacy), and the Agency is…
…University of Maryland School of Medicine Frank Palumbo, Ph.D, JD, Professor and Executive Director, University of Maryland School of Pharmacy Center on Drugs and Public Policy Jacques Ravel, Ph.D, Associate…
…patients recommending a particular birthing center (their example). Similarly, payment to a pharmacy to recommend that all patients on a particular drug be switched to another drug would, apparently, be…
…that will be provided to manufacturers from summary-level information to claims-level information, including, among other things, date of dispensing, prescription number, and pharmacy identifier. Exhibit A to the Agreement provides…
…enforcement action. And LegitScript, a self-proclaimed “leading source of information for patients, Internet users, physicians, businesses and other third parties who need to know if an Internet pharmacy is acting…
…retail pharmacy program. On November 27, the IRS issued Notice 2010-71 explaining how the drug industry fee will be implemented. Although the statute specifies that the fee is to be…
…closed system of controlled drug distribution, thus the return of controlled substances by patients to a DEA registrant, such as a pharmacy, has been prohibited under DEA regulations, with limited…
…or through a wholesale distributor, pharmacy, or similar intermediary, on the sale of any generic or off-patent drug sold or dispensed to any consumer in the state. A price increase…
…strikes down a Vermont law prohibiting the sale, disclosure, and use of pharmacy records that reveal the prescribing practices of individual doctors for use in the marketing of drugs. This…