Pharmacy
FDA Delays Track-and-Trace Enforcement Once Again
The Food and Drug Administration (FDA) has delayed its enforcement of the product tracing requirements under the Drug Supply Chain Security Act (DSCSA) of the Drug Quality and Security Act (DQSA). The DSCSA’s track-and-trace requirements took effect in July 2015, but the FDA stated it would not enforce the product tracing requirements until November 1,…
Read MoreLouisiana Board of Pharmacy Addresses the Compounding of Veterinarian Only Drugs for Office Use
Earlier this year, the Louisiana Board of Pharmacy (Louisiana Board) exercised the emergency provision of the Louisiana Administrative Procedure Act (R.S. 49:9.53.B), to amend its rules governing the compounding of drugs by pharmacies and restored the capability for pharmacies to compound drugs intended for the administration by veterinarians without the necessity of a patient-specific prescription.…
Read MoreNew Telehealth Guidelines Approved by the Colorado Medical Board: Should Colorado Pharmacists Be Concerned?
The Colorado Medical Board (Board) has adopted Guidelines for the Appropriate Use of Telehealth Technologies in the Practice of Medicine (Guidelines) as the state seeks to enact a new law expanding telehealth services. The Board defines “telehealth” as: ‘a mode of delivery of health care services through telecommunications systems, including information, electronic, and communication technologies, to facilitate…
Read MoreVeterinary Compounding: For "Office Use"
As the veterinary compounding market continues to grow and expand, new legal issues arise and, in some instances, the current federal and/or state laws may be in conflict with one another or they may not provide clear guidance on specific topics. Veterinary compounding for ‘office use,’ where a medication is compounded and then sold to…
Read MoreColorado Pharmacy Law: Telehealth and Identifying Valid Preexisting Patient-Practitioner Relationships
The Colorado Medical Board recently published a new draft policy, No. 40-27, on “Guidelines for Appropriate Use of Telehealth Technologies in the Practice of Medicine.” The projected effective date is August 20, 2015. The new guidelines, however, appear to be at odds with the existing Colorado Board of Pharmacy rules that state, in part, the…
Read MoreCalifornia and Oregon To Allow Hormonal Contraceptives Without A Doctor's Prescription
California and Oregon will become the first states to allow women to get birth control pills and hormonal contraceptives directly from their pharmacists, without a doctor’s prescription. California’s rules are expected to take effect after October 1, 2015, while Oregon’s is expected to take effect after January 1, 2016. The contraceptives, however, will not be…
Read MoreCompounding Animal Drugs from Bulk Substances: Draft Guidance Update
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry (GFI) #230 entitled “Compounding Animal Drugs from Bulk Drug Substances.” The draft guidance describes FDA’s policies with regard to compounding animal drugs from bulk drug substances. When final, the guidance will reflect FDA’s current thinking on the issues addressed…
Read MoreVeterinary Compounding and the Drug Quality and Security Act
The Drug Quality and Security Act (DQSA) amends the Federal Food, Drug and Cosmetic Act (FDCA) with respect to human drug compounding. As discussed previously on the Baer Law Blog, Title I of the DQSA amended Section 503A of the FDCA and added Section 503B. Sections 503A and 503B address exemptions from certain FDA requirements…
Read MorePhantom Pharmacist-in-Charge Offers
The Oklahoma Board of Pharmacy (Board) is reporting that Oklahoma-licensed pharmacists are being approached by out-of-state pharmacies (OSP) asking them to be their pharmacist-in-charge (PIC) for their Oklahoma license, despite the fact that the Oklahoma licensed pharmacists to not actually work at the OSP. The increased frequency of requests for “phantom” or “absent” PICs is…
Read MoreAnalyzing Colorado 2014 Prescription Drug Outlet Disciplinary Actions: Repeated Deficiencies
Baer Law recently completed an analysis of thirty-two (32) separate disciplinary actions against Colorado Prescription Drug Outlets (PDOs) by the Colorado State Board of Pharmacy (Board). The Board registers and licenses pharmacy businesses, both in-state and out-of-state, including: Prescription Drug Outlets; Wholesale distributors of prescription drugs; Manufacturers of prescription drugs; Other outlets; and Limited licenses.…
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