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VA Issues Final Rule on Promotion by Pharmaceutical Company Representatives
By Alex J. Varond – On March 5, 2012, the Department of Veterans Affairs (“VA”) issued a final regulation on promotion of drug and drug-related products (i.e., supplies related to…
DOD Issues Guidance on Section 703 Refund Program
…establishes a framework for manufacturers to pay refunds to the government on NDA drugs dispensed to TriCare beneficiaries under the TriCare Retail Pharmacy (“TRRx”) Program. The TriCare Management Authority (“TMA”)…
Try Harder: The OIG Warns Drug Companies of Potential Liability for Medicare Beneficiaries’ Use of Copay Coupons, and Urges CMS to Work with Drug Companies and Other Stakeholders to Reduce Medicare Beneficiaries’ Use of These Coupons
…health care program beneficiaries, although sometimes these disclaimers are present in some coupon formats (e.g., print, electronic) but not others. Second, most manufacturers use pharmacy claims edits to prevent use…
Senator Vitter Proposes to Tweak Statute to Explicitly Permit Office Use Compounding … As Permitted Under State Law, and to Eliminate “Addressing Inordinate Amounts” in FDA’s MOU with States
…Federal Food, Drug, and Cosmetic Act. The amendment addresses confusion over a compounding pharmacy’s “distribution” of compounded preparations and, specifically, compounding for office use (i.e., compounding preparations that are not…
Three Entities (and a Part Owner and Pharmacist in Charge) Likely Must Swallow A Bitter PIL for Their Role in the Opioid Crisis; But … For Now, The District Court Denies Government’s Motion for Preliminary Injunction
…Interestingly, in particular for a pharmacy CSA enforcement matter, the Complaint also alleges the knowing operation of Rite-Away Pharmacy and Medical Supply #2 to unlawfully distribute controlled substances as a…
New Nevada Law Requires Companies to Adopt a Marketing Code of Conduct
…and, if so, how long a company would have to do so. The Nevada Board of Pharmacy may clarify this point in a future rulemaking. Unlike California’s law, the Nevada…
CDC Proposes Updating Practice Guideline for Prescribing Opioids, Warning Against Continued Misapplication
…pharmacies and pharmacy benefit managers have implemented laws, regulations and policies that have misapplied the 2016 guideline. Some have interpreted the 2016 guideline as requiring a hard, daily opioid dosage…
FDA Publishes Interim Guidance on Compounding Using Bulk Drug Substances and Once Again Establishes a Time Period for Comments and Nominations
…now terms the “bulks”) is occurring during FDA’s Pharmacy Compounding Advisory Committee (PCAC) (Oct. 26 and 27). This is the third PCAC meeting this year, at which the PCAC has…
Generic Drug Trade Association Sues to Enjoin Maryland Price Gouging Law
…which also has no operations in Maryland. The wholesaler then sells the product to a local pharmacy in Maryland where an intra-state sale from the pharmacy to the patient is…
FDA Law Alert – May 2020
…and controlled substances distribution and inventory. These waivers meet the dual objectives of enhancing pharmacy response to the ongoing COVID-19 pandemic while also allowing pharmacy staff to responsibly practice social…
United States v. Medistat RX LLC Consent Decree: FDA’s Latest Enforcement Effort Related to Compounders and Title I of the Compounding Quality Act
…or initiated a criminal action (i.e., four) with an offending compounding pharmacy. Based on a review of those few consent decrees and criminal matters, it seems that a key reason…
FDA is Seeking Information on Outsourcing Facility Industry “Challenges”
…more drug manufacturers or pharmacy compounders jumping at the chance to enter into this novel, unique drug space? FDA recently published in the Federal Register a notice seeking comments on…
Discount “Stacking” in Medicaid Rebate Best Price Addressed by Federal District Court
…same drug transaction” should be considered in best price, but then addressed only an example where a rebate paid to a PBM is designed to adjust prices at the pharmacy…
Practitioner DEA Registration Numbers: Some Anomalies to Note
…not follow the agency’s prescribed formula which would be identified by pharmacy verification systems as invalid. DEA registration numbers consist of a formulaic combination of nine alpha and numeric characters…
Keeping Up with ….. FDA’s Drug Compounding Lists: Todays PCAC Meeting
By James E. Valentine & Karla L. Palmer – There are a number of lists that are central to FDA’s regulatory framework for the regulation of pharmacy compounding under sections…