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…particular that they wanted increased guidance and communications with the Agency. Although State Agencies are Satisfied, Associations Want Improved Communications with the Agency. GAO described different communications that state agencies…
…for the drug; have a diagnosis consistent with a labeled indication; have health insurance that covers prescription drugs (including private, commercial, or government health insurance programs); and have experienced a…
…the previously-required caution statement – “Caution: Federal law prohibits dispensing without prescription” – with the “Rx only” symbol. Therefore, the “Rx only” symbol is meant to “communicate the same message…
By Delia A. Stubbs – Last Friday, January 25, 2012, after two days of discussion and deliberation, an FDA Advisory Committee voted 19 to 10 in favor of rescheduling combination…
…potentially proposing further notice-and-comment rulemaking” and whether further action is appropriate. Several compounding guidance documents (see chart below) were published within Priebus “window” because they are still within their comment…
…collaboration” about the Drug Enforcement Administration’s (“DEA’s”) efforts to combat prescription drug abuse. While voicing strong support of DEA’s efforts to fight prescription drug abuse, the letter states that recently…
…manufacturer. The complaints allege that the drug companies’ interference with insurance cost-sharing arrangements violates federal law. First, the complaints allege that the pharmaceutical companies’ co-pay coupon programs constitute substantive RICO…
…the system just before signing and not printing or faxing an electronically transmitted prescription. The burden in on the practitioner to ensure compliance with the proposed regulations and to prevent…
…electronic identification and tracking system to follow drugs through the supply chain, provide grants for community pharmacies to assist them in acquiring hardware and software to comply with the new…
…prohibit the refilling of Schedule II prescriptions. DEA’s final rule amends the regulations to allow individual practitioners to issue multiple prescriptions authorizing patients to receive “a total of up to…
…benefits to eligible Commonwealth of Pennsylvania employees, retirees, and their dependents, sued AstraZeneca alleging, among other things, that the company unlawfully advertised NEXIUM (esomeprazole magnesium) (i.e., the “Purple Pill”) in…
…entities – as part of the process. The rule, when finalized, will replace existing 21 C.F.R. Part 205 (Guidelines for State Licensing of Wholesale Prescription Drug Distributors). The comment period…
Earlier this year, North Dakota enacted a prescription drug price transparency reporting law, HB 1032, that became effective on August 1, 2021. (See our summary here.) This new law requires…
…MCO in writing before the first purchase of the product at that reduced price. The reduction in price must be completely reflected in the price of the prescription pharmaceutical product…
A little more than ten years ago, on March 31, 2010, the Drug Enforcement Administration published its Interim Final Rule (IFR) with request for comments, titled “Electronic Prescriptions for Controlled…