US Food and Drug Administration (FDA) has called for the development of legislation to establish appropriate, minimum federal standards for entities engaged in the compounding of non-patient-specific sterile drugs for interstate distribution, states FDA Commissioner Margaret Hamburg, MD.

To protect the public health, Food and Drug Administration (FDA) should carefully consider using the exercise of enforcement discretion during drug shortages, urges NABP. 

Protecting the public health from counterfeit drugs entering the US is a top priority for the Food and Drug Administration (FDA), stressed FDA Commissioner Margaret Hamburg, MD, at a September 10, 2012, symposium. As part of its efforts, the agency...

FDA alerts the public that certain over-the-counter (OTC) products that are applied to the skin for the relief of mild muscle and joint pain have been reported to cause rare cases of serious skin injuries. These OTC topical muscle and...

Drug Enforcement Administration (DEA) has launched a newly designed Web site featuring new navigation and increased functionality. The new drop-down menu makes it easier to search for specific information and the home page highlights recent news and DEA initiatives. Shortcut...

United States and Chinese officials coordinated efforts to shut down 18 Chinese-language Web sites marketing counterfeit drugs and other dangerous drug products to US consumers. The China State Food and Drug Administration initiated the operation and provided information to the...

Responding to the significant increase in deaths due to overdose of illicit or prescription drugs, federal legislators have introduced a bill that would fund programs to prevent overdose death and require additional tracking of overdose deaths. If it becomes law,...

Consumers can now quickly locate a site for safe disposal of unneeded and expired medications using the Drug Enforcement Administration (DEA) National Prescription Drug Take-Back Day Locator. DEA Take-Back Day collection sites will accept unwanted medications on September 29, 2012,...

Food and Drug Administration (FDA) warns that consumers should not use Reumofan Plus products due to serious health risks related to the presence of prescription drug ingredients not listed on product labels. In a news release, FDA explains that the...

Removing pharmacies’ ability to re-sell drug products to wholesalers would help to prevent medications from being leaked into the gray market, as highlighted in a recent Drug Topics article. NABP Executive Director/Secretary Carmen A. Catizone, MS, RPh, DPh, explained that...

On August 13, 2012, Food and Drug Administration (FDA) announced that the 2012-2013 influenza vaccine formulation has been approved. Additional details and links to information about influenza vaccine availability and related topics are included in an FDA news release. As...

Originally published in the August 2012 NABP Newsletter By Dale J. Atkinson, JD Increased media attention to licensure issues and the performance of regulatory boards provide the public with a perspective of why boards exist and their duties and responsibilities....

Food and Drug Administration (FDA) Drug Info Rounds, a series of online training videos, provides important and timely drug information to practicing clinical and community pharmacists so they can help patients make better medication decisions. In the latest Drug Info...

Groups representing health care providers, researchers, and public health officials submitted a petition (PDF) requesting FDA to change opioid drug labeling so that indications for use in treating chronic, non-cancer pain would be limited. Supporters hope that such a change...

As part of the federal initiative to address the prescription drug abuse, misuse, and overdose epidemic, Food and Drug Administration (FDA) has approved a risk evaluation and mitigation strategy (REMS) for extended-release (ER) and long-acting (LA) opioids. The REMS introduces...

Food and Drug Administration (FDA) has issued a Federal Register notice (PDF) instructing companies to stop manufacturing and distributing certain unapproved drugs that contain oxycodone. The agency indicates in a news release that the “action affects companies that manufacture and...

Two online Webinars focusing on acetaminophen safety will be available to pharmacists and pharmacy technicians in July. Participants will explore factors that commonly contribute to acetaminophen overdosages, review recent regulatory action to support the safe use of acetaminophen, and discuss...

The Food and Drug Administration (FDA) Safety and Innovation Act (S 3187) was passed by United States Congress, June 26, 2012, and would implement provisions addressing counterfeit drugs, synthetic drugs, and drug shortages. The bill would increase penalties for drug...

Florida resident Joel Lester pleaded guilty to conspiring to possess with the intent to distribute synthetic marijuana on Friday, June 8, 2012, before the US District Judge Kenneth A. Marra. DEA reports that Lester owned Nature and Health, a business...

US Marshals seized drug products from Global Biotechnologies, Inc, Portland, ME, on May 31, 2012, at the request of Food and Drug Administration (FDA) and pursuant to a warrant issued by the United States District Court for the District of...

The United States Senate voted against the proposed amendment to the Food and Drug Administration (FDA) Safety and Innovation Act that would have allowed drug importation from Canadian pharmacies on May 24, 2012. The amendment failed in a vote of...

Aimed to help combat prescription drug abuse, an amendment to the FDA Safety and Innovation Act that would reclassify hydrocodone as a Schedule II controlled substance passed in the US senate on May 24, 2012. If adopted as law, “patients...

The National Association of Boards of Pharmacy® (NABP®) has signed the Partnership for Safe Medicines’ (PSM) letter to United States senators to show its support of PSM’s stance that the Prescription Drug User Fee Act should not be amended to...

Centers for Disease Control and Prevention (CDC) issued a statement reminding health care providers that medications labeled as “single dose” or “single use” are to be used for only one patient, and that this practice protects patients from life-threatening infections...

By Dale J. Atkinson, JD Originally Published in the May 2012 NABP Newsletter The common law and statutory immunity principles that protect the regulatory boards from liability are essential to the independent and objective operations and decision-making of the boards...

The White House 2012 National Drug Control Strategy continues the administration’s focus on substance abuse prevention, treatment, and recovery, including the prevention of prescription drug abuse. As noted in the White House executive summary, the strategy includes continued efforts to...

With the recent incidence of counterfeit cancer drugs in the United States supply chain, Margaret Hamburg, MD, commissioner of US Food and Drug Administration (FDA) published a statement stressing the need for stronger laws to deter counterfeit drug activity and...

A new report from the Institute of Medicine (IOM) recommends 13 steps FDA and other organizations can take to strengthen the drug and medical product regulatory systems in developing nations. “More than 80 percent of active pharmaceutical ingredients and 40...

Abbott is warning consumers and health care providers about counterfeit Vicodin ES® purchased via the Internet. Abbott reports that the counterfeit product drug and package do not match that of Abbott’s Food and Drug Administration (FDA)-approved Vicodin ES (hydrocodone bitartrate...

Federal marshals seized more than 1,600 containers of products held by Notions-n-Things Distribution of Bogard, MO, that allegedly violate FDA approval and labeling requirements. Three products were seized from the distributor: “Chickweed Healing Salve, allegedly marketed as a skin cancer...

Originally published in the April 2012 NABP Newsletter In 2011, counterfeit pharmaceuticals made up the largest portion of seized items in the Consumer Safety and Technology category, at 28% when ranked by domestic value, as reported by United States Customs...

A House version of the Online Pharmacy Safety Act of 2011 (HB 4095) was introduced to the US House by Representative Bill Cassidy (R-LA) on February 28, 2012. The Hill reports that Senators Charles Schumer (D-NY) and John Cornyn (R-TX)...

Drug Enforcement Administration (DEA) has issued a proposed rule placing five synthetic cannabinoids into Schedule I of the Controlled Substances Act (CSA). The proposed rule was published in the March 1, 2012, Federal Register and extends the final order that...

Healthy People Co expanded a voluntary nationwide recall of dietary supplements sold under certain brand names for products bought on or before October 25, 2011, indicates a press release on the FDA Web site. Healthy People Co initiated a voluntary...

Representative Brian Bilbray (R-CA) introduced a bill to the US House that would prevent states from requiring inspections of drug or device manufacturers, packagers, or distributors that are duplicative to inspections required by FDA. The Science and Technology Regulatory Relief...

FDA will hold a public hearing on a new paradigm the agency is considering for approval of certain drugs that would otherwise require a prescription, as over-the-counter medications under conditions of safe use. FDA explains that these conditions of safe...

Published in the March 2009 Delaware State Board of Pharmacy Newsletter As a reminder, multiple Schedule II prescriptions for the same patient with different dates are permitted. Prescriptions must be written with the date of issue, may not exceed 90...

Published in the June 2006 Delaware State Board of Pharmacy Newsletter. There have been a number of recent inquiries and some confusion regarding the validity of faxing controlled substance (CS) prescriptions from a practitioner’s office to a pharmacy. The faxing...

Reprinted from the January 2006 North Carolina Board of Pharmacy Newsletter. The question has arrived in the Board office as to the existence of an “expiration date” for prescription orders. The only Regulation that would apply to this situation is...