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DEA Administrative Decisions Update: What’s Prescribed in Vegas . . . Has Got to Stay in Vegas
…in Tulsa, Oklahoma, and Las Vegas, Nevada—carrying an unregistered firearm, and found in his carry-on luggage drugs in pill bottles labeled for other individuals, drugs in unlabeled pill bottles, and…
Do You Hear What I Hear? One Year of OTC Hearing Aids
…established a new category of OTC hearing aids for individuals with mild to moderate hearing loss, allowing them to purchase hearing aids directly from stores or online retailers without the…
Velvet Ropes Can’t Stop the FDA: Effort to Defeat FDA Jurisdiction Based on Club Membership Is Unceremoniously Bounced
…distribution of devices only to PMA members. The decision, arising from two related cases from the United States District Court for the District of South Dakota and a long regulatory…
Farmer Allegedly Harmed by FDA Warning on Tomatoes Sues Under the Federal Tort Claims Act
By Ricardo Carvajal – Seaside Farm, Inc., a South Carolina tomato farmer, has sued the federal government under the Federal Tort Claims Act to recoup losses allegedly suffered as the result…
The Biosimilars State Legislation Scorecard
…Committee Rhode Island (None) South Carolina (None) South Dakota (None) Tennessee (None) Texas S.B. 190 (2013-2014) – Died on Adjournment H.B. 542 (2013-2014) – Died on Adjournment…
Jury Rules on Charges against Owner and Head Pharmacist of NECC
…knowing representation to customers that NECC complied with Massachusetts pharmacy regulations and USP guidelines even though a pharmacy technician, who had voluntarily surrendered his license, worked as a pharmacy technician…
Industry Submits Comments (Nearly 3000) and the Agency Listens: Revised Draft Standard MOU Addressing Section 503A’s Limits on Interstate Shipments of Compounded Medications
…compounded drugs distributed interstate Number of States in which the compounded pharmacy or physician is licensed or into which the compounding pharmacy /physician distributes Whether the state inspected for or…
A Long Time Coming: DEA Regs Finally Authorize Schedule II Prescription Partial Fills
…prescription, must note the quantity dispensed on the face of the written prescription or in the pharmacy’s electronic records, in the written record or the pharmacy’s electronic records of the…
DEA Proposes E-Prescribing Regulations; Cumbersome and Strict Framework Could be an Obstacle to Widespread Adoption
…of an electronic prescription, a pharmacy must check the validity of the prescriber’s DEA registration. “A pharmacy that fails to check the validity of a controlled substance prescription before dispensing…
Franck’s Lab Takes FDA to Task in the 11th Circuit; Picks Off Each of the Government’s Arguments
By Karla L. Palmer – Franck’s Lab Inc., a pharmacy that compounds veterinary drugs and whose bulk animal drug compounding activities were vindicated by a Florida federal district court last…
Two More States Seek to Establish Prescription Drug Importation Programs
…Recognition Agreement” in place with the European Union and Cooperation Arrangements for drug products in place with Australia, Canada, Japan, Russia and Sweden. Under the Florida bill, drugs imported under…
Rep. Eshoo Proposes Draft Biogenerics Bill
…guidance document outlining the regulatory review process that Health Canada will use for a biologic that is similar to an approved innovator biologic. In Canada these product are referred to…
HHS/FDA Safe Importation Action Plan Proposes Two Pathways for Drug Importation
…that allow for the importation of certain drugs from Canada. The demonstration projects must be designed to comply with the federal drug importation laws outlined in Section 804 of the…
OIG Proposes Antikickback Law Safe Harbors and CMP Rules that Would Offer Additional Protections for Pharmaceutical and Device Manufacturers
…part of a solicitation; (2) the pharmacy does not routinely waive the cost-sharing; and (3) the pharmacy either makes a good faith determination of the patient’s financial need or fails…
A Round Up of New State Laws to Control Drug Prices
…and Vermont to establish programs for importing drugs from Canada (see here and here). To help our readers stay informed about state obligations, we’ve summarized below new laws in five…