California Bill Would Implement Stricter Requirements for Pharmacies Compounding Sterile Drugs
Pharmacies compounding sterile drug products for dispensing to patients in California would be required to obtain a license to engage in that practice under a bill (SB 294) introduced to the state’s senate on February 19, 2013. Under the bill, both resident and nonresident pharmacies that compound sterile products for dispensing or shipment into the […]
Read More ›Federal Legislation to Prevent Prescription Drug Abuse Introduced to Senate
Aimed to address prescription drug misuse, addiction, and overdose deaths, the Prescription Drug Abuse Prevention and Treatment Act (SB 348) was reintroduced in the United States Senate by Senator Jay Rockefeller (D-WV) and Representative Nick Rahall (D-WV). The bill includes a number of provisions aimed to prevent diversion and abuse and foster safe use of […]
Read More ›Oklahoma Legislation Would Bring PBMs Under Board of Pharmacy Regulation
Aimed to protect public health, a bill introduced in the Oklahoma Legislature would bring pharmacy benefit managers under the regulation of the Oklahoma State Board of Pharmacy. State representative David Derby, the bill’s sponsor, stated that the “bill is about compliance and safety” and noted that provisions would help to ensure that drugs are stored […]
Read More ›Virginia Bill to Implement Stricter Inspection Requirements for Nonresident Compounding Pharmacies Under Consideration
Stricter inspection requirements for nonresident compounding pharmacies and a clarification that distinguishes compounding from manufacturing are among the statutory changes included in House Bill 2312 currently being considered by the Virginia Legislature. If the bill passes, nonresident pharmacies will be required to submit to the Virginia Board of Pharmacy documentation of an inspection conducted within […]
Read More ›Surprise Inspections in Massachusetts Result in Cease and Desist Orders to 11 Compounding Pharmacies
Partial or complete cease and desist orders were issued to 11 compounding pharmacies by the Massachusetts Department of Public Health (DPH), with another 21 pharmacies cited for minor deficiencies. The actions resulted from a round of surprise inspections of 40 Massachusetts pharmacies engaged in sterile compounding. DPH notes that the pharmacies that received notices of […]
Read More ›Another Counterfeit Cancer Medication Distributed in US, FDA Warns
FDA is alerting health care providers that an unapproved cancer medicine distributed by a United States company, Medical Device King (also known as Pharmalogical), is counterfeit. FDA reports that at least one batch of a counterfeit version of Roche’s Altuzan distributed in the US contains no active ingredient. The agency notes further that even if […]
Read More ›Progress Made in Implementing Recommendations Intended to Prevent Acetaminophen Overdose
Compelling progress has been made by stakeholders seeking to address the public health issue of acetaminophen overdose, indicates a white paper published by the National Council for Prescription Drug Programs (NCPDP). In 2011, NCPDP made recommendations that the health care industry take actions to support the safe use of acetaminophen, including recommending that pharmacies produce […]
Read More ›NABP Member Boards Take Action to Strengthen Regulation of Compounding Practice
With the multistate meningitis outbreak linked to unsafe compounding practices at the New England Compounding Center, state and federal lawmakers, regulators, government officials, and stakeholders, including NABP, are seeking to clarify the law and put in place new systems. Information on actions taken by state boards of pharmacy, including details about the compounding action plan […]
Read More ›Providers Should Ensure Only Diluted Forms of Acetic Acid are Used, ISMP Warns
The Institute for Safe Medication Practices (ISMP) has issued a National Alert Network (NAN) notice (PDF) advising that health care organizations should take immediate steps to ensure that only diluted acetic acid solutions are used in patient care. ISMP advises that the use and purchase of glacial acetic acid, the most concentrated form of acetic […]
Read More ›FDA Committee Recommends Schedule II Classification for Drugs Containing Hydrocodone
The Food and Drug Administration (FDA) Drug Safety and Risk Management Advisory Committee recommended reclassifying hydrocodone combination products as Schedule II controlled substances after a two-day meeting, January 24-25, 2013. The committee voted 19 to 10 in favor of the recommendation after discussing the potential for abuse of drugs containing hydrocodone, either combined with other […]
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