News
Drug Quality and Security Act: Title I – Compounding
On November 23, 2013, the President signed the Drug Quality and Security Act (DQSA) into law. As discussed previously on the Baer Law Blog, the legislation was designed to clarify the Food And Drug Administration’s (FDA) oversight authority over drug compounding and update the federal drug tracking and tracing system. The goal of Title I…
Read MoreFDA Releases Draft Guidance on Section 503B Fees for Outsourcing Facilities.
Section 503B of the Federal Food, Drug and Cosmetic Act (FDCA) created a new Food and Drug Administration (FDA) regulated entity called an ‘outsourcing facility.’ As discussed previously on the Baer Law Blog, a registered outsourcing facility is permitted to compound sterile drugs for human use with or without a prescription after voluntarily registering with…
Read MoreIncreasing the Pharmacy Technician to Pharmacist Ratio: Is Patient Safety at Risk?
Florida House bill, HB 323, increases the number of pharmacy technicians a single pharmacist can supervise from a maximum of three to six. This bill, heard by the House Health Quality Subcommittee on February 5th, could significantly impact the profession of pharmacy and the health and safety of the patients in Florida, but other states are also considering…
Read MoreCompounding Update: Drug Quality and Security Act – Outsourcing Facilities
The Drug Quality and Security Act establishes and regulates a new class of compounding pharmacies called “outsourcing facilities.” What qualifies as an outsourcing facility? To qualify as an outsourcing facility, an entity must compound sterile drugs with or without patient specific prescriptions and comply with the Drug Quality and Security Act’s new rules, which include…
Read MoreCompounding Pharmacy Update: Drug Quality and Security Act
This week, Congress took the final step in approving the Drug Quality and Security Act, a bill that amends the Federal Food, Drug and Cosmetic Act with respect to the regulation of human drug compounding and drug supply chain security. The bill addresses the practice of compounding which has expanded drastically over the past two decades…
Read MoreCompounding and Nonresident Pharmacies
In late 2012, an outbreak of fungal meningitis brought national attention to compounding pharmacies, the sterility and regulation of their compounded products, and the potential patient risks associated with compounded medications. At the heart of the outbreak was a medication called methylprednisolone acetate, a preservative free injectable steroid that was produced at the New England…
Read MoreFive Must Have Estate Planning Documents.
Advance Medical Directives: You chose a personal representative to make healthcare decisions for you in case you become incapacitated or are unable to make healthcare decisions for yourself. Living Will: You specifically address which medical treatments you want to receive in certain instances. This document is generally drafted in conjunction with the advance medical directives. Durable…
Read MorePharmacists Addressing Hospital Readmissions
Did you know that one in five Medicare patients is readmitted within thirty days of a hospital discharge? Two key factors contributing to patients being readmitted are patient failure to fill prescriptions post hospital discharge and medication misadventures resulting from patients being unprepared to manage the medications at home. Historically, there has been very little integration…
Read MoreMedication Therapy Management: What is it?
Medication related problems and medication mismanagement result in an estimated 1.5 million preventable adverse events each year. Pharmacists, the medication experts, are uniquely positioned to proactively identify the potential medication related problems, mismanagement issues and medication errors through their involvement in medication therapy management (MTM) programs. MTM describes the broad range of health care services…
Read MoreWelcome to Baer Law Firm!
The world population reached 7 billion at the end of October 2011. Experts estimate that by 2050 the world will grow by another 2.3 billion. The elderly are living longer while health care costs continue to increase. This means a retiree is forced to spend more and more on health care each year. In America,…
Read More