Pharmacy Updates
Colorado Senate Bill 16-158: Physician Assistant's Performing Functions Delegated by a Physician
On June 1, 2016, Colorado Governor John Hickenlooper signed Senate Bill 16-158: Concerning the Ability of a Physician Assistant to Perform Functions Delegated by a Physician that are within the Physician Assistant’s Scope of Practice. The bill, which went into effect on August 10, 2016, requires that a physician assistant prescription order meet the…
Read MoreCVS Agrees to Pay Millions to Settle Allegations of Filling Forged Prescriptions
Earlier this year, CVS paid $8 million for alleged violations of the Controlled Substance Act in its Maryland pharmacies. Last week, the US Attorney’s Office for the District of Massachusetts announced that CVS has agreed to pay $3.5 million to settle allegations that its pharmacists filled forged prescriptions, mostly for addictive painkillers, between 2011 and…
Read MoreTwo Pharmacists Sentenced to Prison for Adulteration of Drugs
On June 21, 2016, the Department of Justice announced that two Alabama pharmacists were sentenced to prison terms of 12 and 10 months for their roles in the distribution of adulterated drugs. The drugs in question were compounded at the now-defunct compounding pharmacy Advanced Specialty Pharmacy (dba: Meds IV.) Meds IV allegedly compounded numerous drugs…
Read MoreNew Colorado Law Expands Pharmacist Opportunities
On June 6, 2016, Colorado Governor John Hickenlooper signed into law Senate Bill 16-135 which amends the Colorado Pharmacy Practice Act and the Colorado Insurance Code to expand practice opportunities for pharmacist and provide a pathway for reimbursement of pharmacy services. The Bill is expected to go into effect in early August 2016. The Bill includes…
Read MoreFDA's Most Recent Guidance: Prescription Requirements Under Section 503A
On April 15, 2016, the FDA issued draft guidance on the Prescription Requirement Under 503A (Prescription Guidance). The Prescription Guidance sets forth the FDA’s policy concerning prescription requirements for compounding human drug products for identified individual patients under Section 503A of the Federal Food, Drug and Cosmetic Act (FDCA) and addresses: Compounding after the receipt…
Read MoreFDA's Most Recent Guidance: Hospitals and Health System Drug Compounding
Last week the Food and Drug Administration (FDA) announced three new Draft Guidance documents related to drug compounding under the Sections 503A and 503B of the Food, Drug and Cosmetic Act (FDCA): Hospital and Health System Compounding Prescription Requirement Under Section 503A Clarifying the definition of “Facility” under Section 503B This article will focus…
Read MoreA Texas Compounder, the FDA and the Texas Board of Pharmacy: State or Federal Oversight?
Last month the Food and Drug Administration (FDA) alerted health care professionals and patients not to use drug products intended to be sterile that are produced and distributed by IV Specialty of Austin, Texas, due to lack of sterility assurance. The FDA found numerous safety issues during its February 2016 which prompted them to recommend…
Read MoreVeterinary Compounding: Recent State Legislation Updates
State boards of pharmacy continue to have primary responsibility of the day-to-day oversight of state-licensed pharmacies that compound drugs in accordance with Section 503A of the Food and Drug Cosmetic Act (FDCA) while the FDA regulates and inspects registered outsourcing facilities licensed under Section 503B of the FDCA. While the exact definition of compounding may vary…
Read MoreColorado Board of Pharmacy Considering Rule Amendments to Address Medical Board Telehealth Guidelines
As previously discussed on the Baer Law Blog in August, the Colorado Medical Board (Medical Board) adopted Guidelines for the Appropriate Use of Telehealth Technologies in the Practice of Medicine (Guidelines). The Medical Board defined telehealth as: “‘a mode of delivery of health care services through telecommunications systems, including information, electronic, and communication technologies, to…
Read MoreCalifornia & Oregon Pharmacy Update: Pharmacists and Birth Control
In 2016, groundbreaking laws in California and Oregon will allow women to obtain hormonal contraceptive pills, patches and rings directly from pharmacists without a doctor’s prescription — a change many say is more convenient and likely a less expensive option than going to the doctor. Presently, a doctor’s prescription for hormonal contraceptive products is required,…
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