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Prescribing Red Flags, Corresponding Responsibility and DEA Investigations: What’s a Pharmacist To Do?
…Basics for Community Pharmacists The ABCs of 340B Federal Regulation Affecting the Practice of Nuclear Pharmacy Pharmacy’s Impact on Disparities in Research Pharmacists and Patient-Centered Diabetes Care Updates in Alzheimer’s…
California Enacts Law to Increase Drug Pricing Transparency
…or reimbursed by a state purchaser, licensed health care service plan, health insurer, or pharmacy benefit manager (PBM) have reporting requirements under SB 17. It is important to note that,…
State COVID-19 Response: Medical Marijuana and Telemedicine
…waivers issued by state pharmacy regulators in connection with COVID-19 response related to pharmacy staffing and facility licensure and inventory and distribution of controlled substances. Today, we are blogging on…
HHS Broadly Interprets PREP Act Immunity: Reasonable Belief is Good Enough
…are in fact counterfeit, PREP Act immunity still applies for losses arising out of the use of the counterfeit product. If a pharmacy allows its licensed pharmacists to order FDA-authorized…
No Signature Required: FDA Provides Temporary Relief from Obligation to Obtain Physical Signatures for Prescription Drug Samples
…common carrier to either the licensed practitioner or to the pharmacy of a hospital or other healthcare entity specified by the requesting practitioner provided certain conditions are met. 21 C.F.R….
Prescription Drug Wholesalers: Don’t Overlook Non-Resident State License Requirements
…obtained all of the licenses required to operate their business, including a wholesaler license issued by the Moosissippi state board of pharmacy. Owners and management believe that they are ready…
OIG PBM Rebate Rule Delayed – Twice
…the rebates are passed through by the plan or PBM to the dispensing pharmacy; and another for service fees paid to PBMs. Together, these safe harbor amendments were intended to…
I Hear You Knockin’… Preparing for and Managing DEA Inspections (Part 1)
…DEA registrants. See, for example, Federal Court Orders North Carolina Pharmacy, Pharmacy Owner, and Pharmacist-in-Charge to Pay More Than $1 Million and to Cease Dispensing Opioids or Other Controlled Substances,…
Recent Developments in the Medicaid Drug Rebate Program
…vouchers, and free drug programs. The effective date of this amendment is January 1, 2023. Manufacturers provide patient savings programs at the pharmacy counter to defray the patient’s out-of-pocket costs…
Infrastructure Bill Set to Delay Trump-era Rebate Rule to Raise Cash
…(AKS) safe harbor for discounts, so that it excludes manufacturer rebates to Medicare Part D plans (or their pharmacy benefits managers (PBMs)). See 42 C.F.R. § 1001.952(h). At the same…
The Wholesaling Prohibition (Potentially) Demystified? FDA’s Take on Supply Chains for Section 503B Outsourcing Facilities
…a “state licensed pharmacy, federal facility, or licensed physician, which subsequently dispenses the drug pursuant to a prescription.” Draft Guidance III.B.2(e) at 9. Outsourcing facilities may also distribute a compounded…
Court Strikes Down CMS’s Accumulator Adjustment Rule That Threatened Manufacturer Patient Savings Programs
…do not represent a price concession to the pharmacy or other entity involved in the redemption or administration. See 42 C.F.R. §§ 447.505(c)(8)-(12). Insurers argue that the savings programs cause…
CDC Emphasizes Opioid Guideline is Voluntary and Should Support, Not Supplant, Patient Care
…patient-centered care,” in response to the guideline about half of the states enacted legislation limiting initial opioid dosage for acute pain to less than 7-days, and that “many insurers, pharmacy…
CMS Final Medicaid Drug Rebate Rule Details New Misclassification Penalties and Numerous Other Changes
…to extend the 30-day timeframe. The preamble (but not the rule) does state that a manufacturer may request an informal extension of the 30- and 60-day deadlines if there are…
The District of Columbia Proposes Pharmaceutical Detailer Regulations
…previously reported on in January 2008. Under the proposed regulations, pharmaceutical detailers in the District would need to be licensed by the Board of Pharmacy by April 1, 2009. The…