US Attorney General Urges Increase in Accessibility of Naloxone
US Attorney General Eric Holder called the rise in overdose deaths from prescription painkillers and heroin an “urgent public health crisis” and advocated for increased access to and training for the overdose-reversal drug, naloxone, for first responders and law enforcement agencies in a video message on the Department of Justice website. “The transition to – […]
Read More ›West Virginia Considering Legislation to Make PSE Prescription-Only
Aimed to reduce the illegal manufacture and abuse of methamphetamine, a bill that would make pseudoephedrine (PSE) medications available by prescription only has passed the West Virginia Senate. Senate Bill 6 (PDF) would prohibit the sale, transfer, or dispensing of PSE without a prescription, with the exception of drug products that the West Virginia Board […]
Read More ›California Bill Would Allow Pharmacists to Dispense Naloxone Under Approved Protocol
In response to the growing rate of opiate overdose fatalities in California, a bill aimed at expanding access to naloxone hydrochloride has been introduced to the state assembly. If approved, the bill (AB 1535), will allow pharmacists who have completed a training program on the use of opioid antagonists to dispense the overdose reversal medication […]
Read More ›NABP Works With Member Boards, FDA to Implement New Compounding Law for the Protection of Public Health
On November 27, 2013, the Drug Quality and Security Act (Act) was signed into law. This law removes the unconstitutional provisions from Section 503A and adds a new Section 503B to the Federal Food, Drug, & Cosmetic Act. The law also provides for the Food and Drug Administration (FDA) to consult with a Pharmacy Compounding […]
Read More ›FDA Requests that Health Care Providers and Regulators Encourage Outsourcing Facility Registration
Food and Drug Administration (FDA) Commissioner Margaret Hamburg has encouraged entities that purchase compounded sterile drugs to meet the medical needs of patients that cannot be met by FDA-approved products to consider requiring their providers to register as outsourcing facilities with FDA. In addition to sending letters to these entities, Hamburg sent additional letters to state […]
Read More ›NABP’s VAWD Program Strengthened, Not Preempted, by New Federal Law
The Drug Supply Chain Security Act (Act), Title II of the Drug Quality and Security Act, was recently signed into law and contains provisions related to the integrity of the drug distribution supply chain. State boards of pharmacy have received correspondence from attorneys indicating that the Act preempts states from recognizing or requiring NABP’s Verified-Accredited […]
Read More ›New York State to Permit Limited Medical Marijuana Prescribing
New York Governor Andrew Cuomo plans to announce an executive action that would permit limited prescribing of medical marijuana in up to 20 hospitals within the state. According to The New York Times, Cuomo will utilize a 1980 public health provision, the Antonio G. Olivieri Controlled Substance Therapeutic Research Program, to implement his plan without approval […]
Read More ›Court Grants Temporary Injunction Against OK Compounding
On August 29, 2013, the District Court of Tulsa County in the state of Oklahoma granted a temporary injunction to enjoin the defendants, including Christopher Parks and OK Compounding, LLC (collectively, OK Compounding), from engaging in certain conduct in connection with plaintiff Rush University Medical Center (Rush). Among other things, the temporary injunction prohibits OK […]
Read More ›USP Adopts Labeling Standards for Ferrules and Cap Overseals to Protect Patient Safety
United States Pharmacopeial Convention (USP) labeling standards for ferrules and cap overseals that require warning messages with vital information aimed to prevent imminent life-threatening situations became official on December 1, 2013. “The standards explicitly state that warning messages – such as ‘Warning – Paralyzing Agent’ or ‘Dilute Before Using’ – are the only markings that […]
Read More ›FDA to Host Public Meeting on Medical Gas Regulations
FDA will hold a public meeting to obtain feedback on whether any changes to regulations concerning medical gas are needed. The meeting will take place on December 6, 2013, from 9 AM to 5 PM and will also be streamed online. FDA is using the public meeting as part of a review process initiated by […]
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