…discount, and the pharmacy will provide the discount to the beneficiary at the point of sale.  The Part D sponsor will subsequently reimburse the pharmacy for that amount.  The Part…

FDA and the University of Rhode Island College of Pharmacy will co-sponsor an interactive forum from June 30 through July 1, 2008 at the Hyatt Regency in Bethesda, Maryland on…

…to the AKS Safe Harbors Cost-sharing waivers by pharmacies: In the Final Rule, the OIG added a safe harbor to protect the waiver or reduction by a pharmacy of cost…

…the appropriate State Board of Pharmacy for review and consideration of corrective actions to bring the pharmacy back into compliance with state law. What authority, with clear congressional intent to…

…“The 30 % Limit” — The new draft MOU requires states to review compounding records during pharmacy inspections to determine whether the physician, pharmacist or pharmacy’s interstate distributions are “inordinate,”…

…or operates a compounding pharmacy would be required to submit to a database specific information, including contact information for the pharmacy; the state of licensure; compounding methods used; and any…

…(“FCP”) limitations to all prescriptions filled on or after January 28, 2008 under the TRICARE Retail Pharmacy Program.  While that decision represented a victory for DoD, the court also criticized…

…percentage. Canada (-4%) and the U.K. (-1%) were the only countries that experienced a net decrease over OPQ’s 5-year survey. Measured in raw numbers, the U.S. is still the registered…

…with over 430 sites, and after that, several countries in Europe and in Asia each had over a hundred catalog sites, including Germany, Canada, Italy, France, Japan, the U.K., and…

…remedy Judge Korman ordered is erroneous for (at least) two reasons: First, the Court exceeded its authority by issuing an order concerning the “one-pill product,” i.e., Plan B One-Step (PBOS),…

…rulemaking process to permit the importation of certain drugs from Canada – something that HHS is doing anyway. HHS issued a proposed rule in December 2019 that would implement Section…

…the draft guidance makes clear, those benefits won’t come cheap.  There are numerous eligibility criteria that must be satisfied, but the ones that we believe merit greatest attention are these: …

…of the 1,400 drugs registered between 1975 and 1999 -over a 25-year-period- fewer than 1 percent of the 1,400 drugs registered treated such diseases.  This disparity is clearly due to…

…Past and Future The American Academy of Neurology’s Happy Birthday, Hatch-Waxman: What 40 Years of Generic Drug Access Has Done for Neurology The Orrin G. Hatch Foundation’s For cheap generic…

…with another FDA 180-day exclusivity forfeiture decision concerning the often-cited failure-to-obtain-timely-tentative-(or final)-approval forfeiture provision at FDC Act § 505(j)(5)(D)(i)(IV). The latest decision we obtained from FDA is interesting as it…