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Department of Defense Issues Proposed Rule for the TRICARE Retail Pharmacy Refund Program
…a retail network pharmacy, and a drug for which the TRRx Pharmacy Benefits Program is the secondary payor. The proposed rule would require manufacturers to enter into written refund agreements,…
Mass. Court Permits Pharmacy Mailing Program, But Requires Disclosure of Profits
…CVS pharmacy to fill his diabetes drug prescriptions. In 1997, Mr. Kelley received a letter on CVS stationery from the “Staff of CVS/Pharmacy” explaining to him the detrimental effects of…
When Must Pharmacists Verify a Prescriber’s DEA Registration? Two Recent Decisions Muddy the Waters
…JM Pharmacy case, the Administrator denied the applications the COR because she found the pharmacy had falsified the application for registration, but noted that only nominal weight would be given…
District Court Rules that Maine Drug Importation Law is Unconstitutional and Preempted by the FDC Act
…foreign countries (i.e., Canada, Australia, New Zealand, and the United Kingdom), is unconstitutional under the theory of field preemption. In doing so, Judge Torresen granted a Motion for Judgment on…
Disclosures in a Small Space: The FTC’s Revisions to .Com Disclosures
…2000 version, continues to emphasize that advertisers should consider the following factors in determining whether an online disclosure is clear and conspicuous: Placement of the disclosure and how proximate it…
Telemedicine and the Prescribing of Controlled Substances After the End of The Covid-19 Pandemic Emergency: DEA Announces Two Significant Proposed Rules: Read the Summary Below, But Learn All the Details and More at HPM’s Webinar on March 23, 2023 (Details Forthcoming….)
The 2008 Ryan Haight Online Pharmacy Consumer Protection Act placed strict limits on online prescribing or the use of telemedicine encounters to prescribe controlled substances. The Ryan Haight Act was…
Congress Passes Legislation To Regulate Controlled Substance Dispensing Over the Internet
…“online pharmacy” will be a separate category of registrant on the registration application.); 3. The pharmacy reports to DEA the quantity dispensed over the Internet if it dispenses 100 prescriptions…
FDA and California Board of Pharmacy Talk Pedigree at Annual HDMA Track and Trace Conference
…track and trace and pedigree systems. Turning to the state level, Virginia Herold, the Executive Officer of the California Board of Pharmacy, spoke about California’s state pedigree requirements, which are…
Congressman Markey Introduces Legislation Increasing Regulatory Oversight of Pharmaceutical Compounding
…that hospital system;” (2) a pharmacy or pharmacist that compounds sterile drug products; and (3) a “pharmacy or pharmacist that compounds drug products in limited quantities before the receipt of…
Imposing Needless Burdens on Small and Large Businesses, FDA’s Proposed Regulations on Menu and Vending Machine Labeling Requirements Need More Work
…a covered establishment would include chain restaurants, certain grocery stores, certain convenience stores, and coffee shops, but would exclude movie theaters, airplanes, trains, and amusement parks. Calorie information for variable…
HP&M Announces Addition of New Of Counsel: Mark I. Schwartz
…from Duke University School of Law and l’Université de Sherbrooke (Canada), as well as a Bachelor of Science degree from McGill University (Canada). Mr. Schwartz has been an Adjunct Professor…
D.C. Circuit Sides with Manufacturers in Latest 340B Contract Pharmacy Case
…2021, when HRSA threatened enforcement against manufacturers who tried to limit shipments of their 340B drugs to covered entity’s in-house pharmacy and a single contract pharmacy. A number of drug…
A New Attack in the Opioid Crisis: “First of its Kind” Motion for an Ex Parte Temporary Restraining Order and Complaint Against Two Tennessee Pharmacies and Their Pharmacists, Alleging Unlawful Opioid Dispensing and False Claims Act Violations
…Tennessee against two affiliated Celina, Tennessee, pharmacies — Oakley Pharmacy, Inc., d/b/a Dale Hollow Pharmacy and Xpress Pharmacy; the pharmacies’ owner, Thomas Weir; and pharmacists John Polston, Michael Griffith, and…
Veterinary Compounding Pharmacy Resumes Operations Despite FDA’s Attempt to Obtain a Preliminary Injunction
By William T. Koustas – Franck’s Lab, Inc. (“Defendant”), an Ocala, Florida veterinary compounding pharmacy, resumed compounding after a federal judge in the United States District Court for the Middle…
Pharmacy Associations Challenge Final CMS AMP Rule; Legislative Fixes Pending in Congress
…2007, but comments may be submitted to CMS until January 2008, after which time CMS will consider revising the regulations. Earlier this month, two pharmacy associations — the National Association…