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AMA Tells Pharmacists: “Don’t Call Us We’ll Call You”
…“Rogue Pain Clinics” & “Pill Mills,” Prescription Drug Awareness Conference, May 4-5, 2013, unnumbered slides. However, if the American Medical Association (“AMA”) adopts either of two committee resolutions at its…
DEA Proposes to Permit the Electronic Transfer of Initial Electronic Prescriptions for Schedules II-V Controlled Substances: Comment Period Ends January 18, 2022
…an electronic data file) to the patient to take to another pharmacy. DEA regulations currently do not include any provision for a pharmacy to transfer an EPCS to another pharmacy….
New Legislation Would Legalize Personal Importation of Certain Foreign Drugs
…Fairness Act of 2013 (H.R. 3715) would allow Americans to buy prescription drugs from certain countries deemed to have comparable safety standards to the United States, including Australia, Canada, Israel,…
“It’s In the Mail” Will Soon No Longer Apply to DEA Registration Applications
…eliminating the “mail-in” option, believing that initial and renewal applications submitted online will be more effective for the agency and registrants. Requiring Online Submission of Applications for and Renewals of…
There’s a New Reporting Tool in Town
By Jennifer M. Thomas – Last week, FDA rolled out a new online reporting program, titled “Reporting Allegations of Regulatory Misconduct,” with little fanfare. No blog post in FDA Voice,…
Food Design and the 2010 Dietary Guidelines: If Food Companies Comply, Will Consumers Buy?
…Act of 2010 authorizes USDA to set nutritional standards for foods sold in schools, including vending machines, lunch lines, and school stores. Combating the problem from a different angle, Alabama’s State…
As Maine’s Drug Importation Law Goes Into Effect, State Seeks Dismissal of Lawsuit to Block Implementation
…“2013 Amendment”): does not affirmatively “authorize” Maine residents to buy prescription drugs from pharmacies located in Canada or any other country, and it does not “aid and abet violations” of…
GPhA Blasts FDA’s Generic Drug Labeling Proposal as Unworkable; Depicts a Dystopian Future
…choice: take a red pill and know the painful truth of reality, or take the blue pill and be blissfully ignorant of the illusion. Of course, Neo takes the red…
OIG Issues Favorable Advisory Opinion on Drug Manufacturer’s Direct-To Patient Discounted Drug Sales Program
…the pharmacy pursuant to a bailment arrangement, under which the manufacturer retains title to the product until the Pharmacy dispenses it to patients. The manufacturer pays the pharmacy a fair market…
Animal Drug “Compounding”: Criminal Indictment Against Pharmacy and Veterinarian Withstands Federal District Court’s Scrutiny
…Pharmacy). In fact, the indictment did not even allege that any act of compounding occurred by either the pharmacy or the veterinarian. It instead described the criminal actions as only…
Fifth Circuit Vacates District Court “Second Inspection Ruling” in Compounding Pharmacy Case
…Agency may conduct limited inspections of pharmacy records to determine if pharmacy-compounded drugs comply with FDC Act § 503A (pharmacy compounding) and § 512(a) (new animal drugs) when FDA failed…
Not In Our Backyard! Pharmacists and Trade Groups Sue to Block Implementation of Maine Drug Importation Law
…drugs to their patients in the practice of their respective professions where specifically authorized to do so by law; B. A licensed retail pharmacy that is located in Canada, the…
Code Blue All Clear: DEA Proposes Registering Emergency Medical Services Agencies
…and stored in, EMS vehicles under the control of the consultant practitioner’s registration or hospital’s registration. DEA proposes allowing registered EMS agencies to store controlled substances in EMS vehicles at…
Trump Administration Takes a Turn at Medicare Part B Payment Reform
…other developed economies (Austria, Belgium, Canada, Czech Republic, Finland, France, Germany, Greece, Ireland, Italy, Japan, Portugal, Slovakia, Spain, Sweden, and United Kingdom). The HHS analysis found that, on average, the…
Electronic Controlled Substance RXs: Signed, Sealed, Delivered But Can’t be Filled
If a patient presents a paper prescription for a controlled substance to a pharmacy and the pharmacy cannot fill it, the patient can take that prescription to another pharmacy. However,…