News tagged headline
A Canadian company is allegedly filling prescriptions in India and other countries for patients in Maine, according to a complaint filed by the president of the Maine Pharmacy Association.Read More →
Food and Drug Administration is advising consumers not to purchase or use Lite Fit USA and Infinity, two products marketed as dietary supplements for weight loss.Read More →
In the latest FDA Drug Info Rounds video, pharmacists discuss how to search the “Electronic Orange Book.”Read More →
The interaction and potential conflict between federal and state law can present interesting issues for regulatory boards that, at times, may be difficult to reconcile.Read More →
Now available online, the Drug Enforcement Administration (DEA) National Prescription Drug Take-Back Day collection site locator allows consumers to search for a nearby location to dispose of unneeded medications on Saturday, April 26, 2014.Read More →
The National Council for Prescription Drug Programs (NCPDP) has issued new recommendations and guidance for standardizing the dosing designation used on prescription container labels of oral liquid medications dispensed by community pharmacies in order to reduce dosing errors.Read More →
In response to a growing number of opioid-related deaths, Massachusetts Governor Deval Patrick declared a public health emergency.Read More →
In an effort to protect health care providers and personnel who handle hazardous drugs, United States Pharmacopeial Convention (USP) has proposed new General Chapter <800> Hazardous Drugs – Handling in Healthcare Settings.Read More →
The Countryside Police Department has received approval to implement a new Overdose Prevention Program in partnership with the Chicago Recovery Alliance.Read More →
Aimed to promote patient care, a Missouri bill would require that health benefit plans reimburse when pharmacies dispense less than a 30-day supply for the purpose of synchronizing a patient’s chronic medications.Read More →
Shire Pharmaceuticals has initiated a voluntary recall of three lots of VPRIV® (velaglucerase alfa for infusion) due to the presence of particulate matter, identified as stainless steel and barium sulfate.Read More →
A group of investigators at Massachusetts General Hospital recently analyzed factors that increased the risk of recurrent opioid overdoses requiring emergency department visits.Read More →
To the consumer (and perhaps the legislature), the time it takes to process, investigate, formally charge, and adjudicate an administrative complaint (or negotiate a consent order) can appear to be lengthy.Read More →
Senator Joe Manchin (D-WV) has introduced Senate Bill 2134 (PDF), which would withdraw Food and Drug Administration (FDA) approval of Zohydro™ ER (hydrocodone bitartrate).Read More →
Recently, NABP discovered that the Internet drug outlet, WellnessFitnessNutrition, LLP (WFN), was fraudulently claiming to hold certain NABP certifications.Read More →
Pain Free by Nature, LLC, of Woodland Park, CO, is recalling all “Reumofan Plus” tablets purchased through its website because they contain undeclared methocarbamol and diclofenac, making the product an unapproved drug.Read More →
US Attorney General Eric Holder called the rise in overdose deaths from prescription painkillers and heroin an “urgent public health crisis.”Read More →
Pfizer, Inc, has voluntarily recalled three lots of its anti-depressant medication, Effexor XR®.Read More →
People who frequently abuse opiate painkillers are often at the highest risk of overdosing, and are also likely to obtain the drugs through multiple prescriptions and multiple doctors, a practice known as “doctor shopping.”Read More →
CDC has issued new warnings about prescribing practices for antibiotics.Read More →
The administrator of Drug Enforcement Administration (DEA) has issued a final order to temporarily schedule 10 synthetic cathinones into Schedule I of the Controlled Substances Act effective as of March 7, 2014.Read More →
New rules for hydrocodone combination products that would move the controlled substance medications from Schedule III to Schedule II have been proposed by Drug Enforcement Administration.Read More →
FDA has announced a public hearing to review the agency’s Over-the-Counter Drug Review process, including strengths and weaknesses of the current process and ideas about modifications or alternatives.Read More →
Food and Drug Administration has developed a 10-year plan for implementation of the Drug Supply Chain Security Act.Read More →
Established to enhance the security of imported drugs, FDA’s Secure Supply Chain Pilot Program will launch with the participation of 13 companies prequalified by the agency.Read More →
Steps taken by FDA have successfully reduced the number of new drug shortages, and a new study from the Government Accountability Office urges the agency to take additional steps to reduce the number of overall drug shortages.Read More →
Moving one step closer to providing consumers worldwide with an easy way to identify safe online pharmacies and resources, the National Association of Boards of Pharmacy® (NABP®) has been deemed eligible to enter contract negotiations with the Internet Corporation for Assigned Names and Numbers (ICANN) to own and operate the .pharmacy domain suffix.Read More →
The Accreditation Council for Pharmacy Education has released the Draft Revised Standards for the Professional Program Leading to the Doctor of Pharmacy Degree and the Guidance Document to Standards 2016 for public review and comment.Read More →
The Missouri House of Representatives has approved a bill that would establish a prescription monitoring program.Read More →
Aimed to reduce the illegal manufacture and abuse of methamphetamine, a bill that would make pseudoephedrine medications available by prescription only has passed the West Virginia Senate.Read More →
Consumers should not purchase or use Arth-Q, a product promoted and sold as a dietary supplement for joint, muscle, and arthritic pain, Food and Drug Administration warns.Read More →
CVS Caremark has announced its plan to stop selling tobacco products in all of its stores by October 1, 2014, in support of patient and customer health.Read More →
Aimed to reduce the abuse of cough medications, the Preventing Abuse of Cough Treatments of 2014 Act (PACT Act), has been introduced to the United States House of Representatives.Read More →
Since the implementation of New York state’s Internet System for Tracking Over-Prescribing Act (I-STOP) in August 2013, “doctor shopping” – when patients visit multiple doctors to obtain controlled substance medications – has been reduced by 75%.Read More →
Kevin Lowe, former owner and operator of a Bronx, NY medical clinic and 23 others have been arrested on charges related to a massive “pill mill” operation that involved approximately 31,500 medically unnecessary prescriptions for oxycodone with an estimated street value of up to $550 million.Read More →
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.Read More →
A former pharmacist, Jeffrey Clawson, has been sentenced to a 15-year term in Adams County Community Corrections for his role in an oxycodone trafficking scheme.Read More →
A Food and Drug Administration decree has prohibited Ranbaxy Laboratories, Ltd, from manufacturing and distributing active pharmaceutical ingredients from the company’s facility in Toansa, India, for use in FDA-regulated drug products.Read More →
In 2011, Pennsylvania had the 14th highest rate of drug overdose deaths in the country, with counties in the southwestern portion of the state experiencing even higher rates of overdose deaths.Read More →
Leonard “Lenny” Stefanelli, the former pharmacist-in-charge of West Orange Pharmacy, West Orange, NJ, admitted to illegally dispensing hundreds of tablets of OxyContin® and for submitting fraudulent bills to health care benefit providers over the course of two decades.Read More →
The Accreditation Council for Pharmacy Education has announced the members of the 2014-2015 ACPE Executive Committee.Read More →
In response to questions concerning United States Pharmacopeia-National Formulary General Chapters <795> and <797>, USP has created a new frequently asked questions page on its website.Read More →
he Mentholatum Company of Orchard Park, NY, has issued a voluntary recall of some Rohto eye drop products due to a manufacturing review at the production facility in Vietnam involving sterility controls.Read More →
Drug Enforcement Administration has announced another opportunity for consumers to dispose of unneeded and expired prescription drugs.Read More →
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.Read More →
Fourteen facilities are the first to be registered as Human Drug Compounding Outsourcing Facilities with Food and Drug Administration (FDA) under the DQSA.Read More →
In light of all the recent news alerts and warnings about the use of acetaminophen and acetaminophen containing products, the FDA issued a recommendation of importance to pharmacists, prescribers, and patients.Read More →
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.Read More →
Baxter International Inc, has issued a voluntary recall of two lots of CLINIMIX and one lot of CLINIMIX E Injection parenternal nutrition products to the user level following complaints of particulate matter found in the products.Read More →
Mass Destruction, a product marketed online and in retail stores as a dietary supplement for muscle growth, has been associated with at least one reported serious illness, reports FDA.Read More →
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).Read More →
Abrams Royal Compounding Pharmacy of Dallas, TX, and Food and Drug Administration (FDA) have announced a voluntary recall of all unexpired lots of sterile products after a report of an adverse event involving mineral IV injection, Lot Number 11142013@74.Read More →
Hospira, Inc, of Lake Forest, IL, has initiated a voluntary recall for one lot of Lidocaine HCl Injection, USP 2%, 5 mL Single-Dose Vial, National Drug Code 0409-4276-01, Lot 32-135-DD due to the presence of particulate matter.Read More →
Results of the 2013 Monitoring the Future survey (PDF) show abuse of most types of prescription drugs among teens remained relatively stable in 2013.Read More →
Rx Formulations of Mesa, AZ, and Food and Drug Administration (FDA) have announced a voluntary recall of some compounded sterile products after 2 to 3 millimeter, irregularly shaped floating matter was observed in an intact, unused vial of calcium gluconate injection produced at the facility.Read More →
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.Read More →
In preparation for National Drug Facts Week (NDFW), community organizations are invited to register drug abuse awareness events online.Read More →
Appointment-based medication synchronization programs improve patient adherence by 3.4 to 6.1 times, a study published in the November/December 2013 issue of the Journal of the American Pharmacists Association reports.Read More →
IQ Formulations of Sunrise, FL, is initiating a voluntary nationwide recall on all lots of its 45-capsule bottles of HYDRAVAX due to potential inclusion of an unlisted ingredient.Read More →
Centers for Disease Control and Prevention is encouraging health care providers to remind patients and caregivers of patients six months and older that it is not too late to get a flu vaccine.Read More →
FDA and Baxter International, Inc, have issued a voluntary recall of one lot of nitroglycerin in 5% dextrose injection due to the presence of particulate matter found in one vial.Read More →
Of 125 hospital pharmacy directors in Texas, more than 85% reported that they have been contacted by gray market vendors offering to sell drugs in short supply.Read More →
College students are taking to Twitter to talk about prescription drugs, often revealing how they misuse medications, according to two recent studies.Read More →
Prescription drug abuse continues to be the nation’s fastest growing drug problem, and abuse of controlled substance prescription drugs poses a significant drug threat to the United States, stresses the Drug Enforcement Administration (DEA) in 2013 National Drug Threat Assessment Summary.Read More →
A Michigan pharmacy owner and eight staff members have been indicted on charges of conspiracy to misbrand drugs.Read More →
To better address the needs of its Web site users, Food and Drug Administration (FDA) has upgraded its Web site for improved viewing on tablets, smart phones, and other mobile devices.Read More →
Food and Drug Administration is warning consumers about male lifestyle dietary supplements containing undeclared ingredients.Read More →
A Michigan law passed by the state’s Senate would allow patients to purchase medical marijuana from licensed pharmacies as a Schedule II controlled substance.Read More →
FDA has published new Drug Info Rounds videos.Read More →
Drug Enforcement Administration reports that nearly 650,000 pounds of unneeded prescription medications were properly disposed of during the October 26, 2013 National Prescription Drug Take-Back Day.Read More →
In an ongoing effort to reduce drug shortages, Food and Drug Administration has released a strategic plan and has also proposed a new early notice rule for manufacturers.Read More →
The 2013 United States Pharmacopoeia (USP) Chapter <797> Compliance Survey, the third annual report released since 2011, shows that the overall compliance rate of 77.2% remains nearly unchanged from the 2012 rate.Read More →
As many as one in 10 teenagers who visited an emergency department (ED) reported abuse of prescription painkillers or sedatives within the last year, University of Michigan researchers report in a study published in Pediatrics.Read More →
Nine defendants, including three licensed pharmacists, face federal charges related to their alleged roles in operating a prescription painkiller ring on the East Coast, NBC News reports.Read More →
Food and Drug Administration (FDA) plans to submit a formal recommendation to reclassify hydrocodone combination products as Schedule II controlled substances.Read More →
Tip-offs that an Internet drug seller may be fraudulent include offering prescription drugs without requiring a valid prescription and too-good-to-be-true prices, warns a new FDA consumer video.Read More →
Americans throughout the country will have the opportunity to dispose of unneeded or unwanted medications at a Drug Enforcement Administration National Prescription Drug Take-Back Day collection site on Saturday.Read More →
The Massachusetts House has passed a bill that would make random unannounced inspections of compounding pharmacies a permanent requirement.Read More →
Peter Riccio, owner of pharmacies in Hellertown and Palmer, PA, pleaded guilty to charges of illegal distribution of the drug butalbital, a Schedule II narcotic.Read More →
On occasion, civil and criminal judicial decisions maintain relevance to the regulatory community and are of interest to boards of pharmacy.Read More →
A Maine law allowing for the direct purchase of mail-order prescription drugs from foreign entities is facing legal challenges.Read More →
The next opportunity to dispose of any unneeded or unwanted medications at a Drug Enforcement Administration (DEA) National Prescription Drug Take-Back Day collection site will be Saturday, October 26, 2013.Read More →
Food and Drug Administration (FDA) and Hospira, Inc, of Lake Forest, IL, have issued a voluntary recall of one lot of 1% Lidocaine HCI Injection, USP, 10 mg/mL, 2 mL Multiple-dose Fliptop Vial, National Drug Code 0409-4276-01, Lot 25-090-DK.Read More →
Governor Brown signed two bills into law that aim to reduce prescription drug abuse by enhancing the state’s prescription monitoring program and by making it easier for the medical board to investigate patient records after a suspicious death.Read More →
Food and Drug Administration (FDA) is warning patients and health care providers that budesonide solution (for nasal irrigation), dispensed by The Compounding Shop of St Petersburg, FL, may be contaminated and should not be used or administered to patients.Read More →
To reduce the risk of accidental exposure, FDA has announced new requirements that change the appearance of fentanyl pain patch warnings to make them more visible.Read More →
In Florida, deaths tied to prescription drugs dropped by 17.7% and deaths caused by oxycodone plunged by 41%, state officials announced in a recent report.Read More →
A group of drugs known as “bath salts” were linked to an estimated 22,904 visits to hospital emergency departments in 2011.Read More →
State senators from Nevada and California are calling on Craigslist to remove ads from its site that facilitate illegal distribution and diversion of narcotics.Read More →
A series of bills have been introduced to the Michigan Legislature that would include several provisions intended to strengthen the regulation of compounding in the state.Read More →
A new report from CDC warns that there is a growing threat of antibiotic-resistant strains of infectious diseases.Read More →
To combat the misuse and abuse of extended-release and long-acting (ER/LA) opioids, Food and Drug Administration (FDA) is announcing class-wide label changes to ER/LA opioids, including a statement indicating the medications should be prescribed when the patient requires constant treatment of severe pain and when alternative methods are inadequate.Read More →
With flu shots now available across the country, and consumers stocking home medicine cabinets ahead of the coming cold and flu season, the Acetaminophen Awareness Coalition has issued a consumer message to “Double Check, Don’t Double Up” on acetaminophen when treating winter illnesses.Read More →
Food and Drug Administration (FDA) and University Compounding Pharmacy of San Diego, CA, have issued a voluntary recall of several products.Read More →
FDA Drug Info Rounds, a series of online videos, provides important and timely drug information to practicing clinical and community pharmacists.Read More →
Food and Drug Administration (FDA) and Park Pharmacy & Compounding Center of Irvine, CA, have announced a voluntary recall of two lots of products that were dispensed to patients and distributed to physician offices by prescription in June and July 2013 in California, Florida, New Mexico, and Indiana.
The Medical Licensing Board of Indiana is considering emergency rules related to opioid prescribing as mandated by the state’s “pill mill bill” (SB 246), which was signed into law by Governor Mike Pence in May 2013.
In an effort to reduce prescription drug abuse, CVS pharmacists have adopted an analytical system to help identify “pill mill” prescribers.
Food and Drug Administration updated its label requirements for the drug labels on fluoroquinolone-based medications.
After NuVision Pharmacy refused FDA’s most recent request to recall all of its sterile products, FDA is reminding health care providers not to use NuVision sterile products.
Specialty Compounding, LLC, clarified a recall of all lots of sterile compounded medications produced in its Texas facility.
The Consumer Healthcare Products Association (CHPA) has filed a citizen petition to FDA that asks the agency to provide convenient and accurate access to dosing information for children ages six months to two years.
The risks of ordering medications online and of receiving dangerous counterfeit products are highlighted in a recent NBC Connecticut report.
US Department of Justice (DOJ) officials indicted 11 people on 17 different charges related to the illegal importation and distribution of non-Food and Drug Administration (FDA)-approved drugs into the US.
United Parcel Service (UPS) has become the first global package delivery organization to join the Center for Safe Internet Pharmacies (CSIP) as a strategic partner and board member.
Food and Drug Administration (FDA) has announced a voluntary recall of all lots of unexpired sterile products produced by Specialty Compounding, LLC, in Cedar Park, TX.
In a July 2013 report, the United States Government Accountability Office (GAO) recommends that “Congress should consider clarifying FDA’s authority to oversee certain entities that compound drugs.”
FDA has issued a Consumer Update that warns of rare but serious skin reactions that may occur in patients taking acetaminophen.
Alabama Governor Robert Bentley has signed into law three bills aimed to reverse the state’s growing prescription drug abuse rate.
On August 1, 2013, Illinois Governor Pat Quinn signed into law the Compassionate Use of Medical Cannabis Pilot Program Act, making Illinois the 21st state to legalize some form of medical marijuana.
Nova Diabetes Care and Food and Drug Administration (FDA) officials have announced a voluntary recall of 21 lots of blood glucose test strips.
According to a state report released in late July, drug overdose deaths in the state of Kentucky decreased by 19 to 1,004.
Food and Drug Administration (FDA) stresses that domperidone is not an FDA-approved drug, and that it may not be legally marketed in the US.
FDA is warning consumers not to use a product marketed as a Vitamin B dietary supplement due to the presence of potentially harmful anabolic steroids.
FDA advises consumers not to use, and is taking action to remove from the market, illegal products claiming to treat diabetes.
A bill calling for a 30-member commission to coordinate law enforcement and health agency efforts to combat prescription drug abuse was introduced to the United States Senate.
Five individuals have been indicted and arrested on charges related to their involvement in a prescription drug diversion scheme.
Paul Bottomley of Montana forfeited nearly $6 million in cash and property and was sentenced to five years probation for his role in the scheme that imported fake cancer drugs into US clinics, ultimately reaching patients.
FDA is alerting consumers to be mindful of the amount of acetaminophen they take in order to prevent overdose and potential liver damage.
Attorneys General are calling on Google to remove video ads from YouTube that promote rogue Internet sites marketing medications, including controlled substances, as “no prescription required” products.
While facing the challenges of investigating and prosecuting complex, global operations, federal agencies in the United States continue to take action against Web sites illegally distributing prescription drugs to US consumers.
The problem of counterfeit drugs distributed into the US via rogue Internet drug sellers is growing, FDA consumer safety officers told CNN’s Sanjay Gupta, MD, as part of a special report.
Every day, approximately 18 women die from an overdose of prescription pain medication, reports the Centers for Disease Control and Prevention (CDC).
Drug Enforcement Administration (DEA) will provide another opportunity for consumers to dispose of unneeded and expired prescription drugs during the 7th DEA National Prescription Drug Take-Back Day, October 26, 2013.
As part of its efforts to prevent accidental exposure to fentanyl patches, FDA is providing new resources about safe storage and safe disposal of the patches.
As part of the sixth annual International Internet Week of Action (IIWA), Food and Drug Administration (FDA) took action against more than 9,600 Web sites illegally selling drugs that included counterfeit, substandard, and other potentially dangerous products.
Med Prep Consulting, Inc, has been prohibited from manufacturing, holding, and distributing drug products under a consent decree of permanent injunction entered against the pharmacy by a federal court.
The American Medical Association (AMA) has adopted a resolution stating that the organization deems certain pharmacy inquiries relating to the verification of prescriptions to be “an interference with the practice of medicine and unwarranted.”
Many Americans are not adhering to prescribed medication regimens, indicates a new patient survey commissioned by the National Community Pharmacists Association (NCPA).
One lot of Rugby Laboratories enteric coated aspirin tablets, 81 mg, has been recalled to the user level.
With Institute for Safe Medication Practices (ISMP) Medication Safety Alert! publications making a significant impact on preventing medication errors, the organization will soon be providing a new resource tailored to long-term care facilities.
As a result of an investigation initiated in May 2013, FDA has identified bacterial and fungal growth in products compounded by Main Street Family Pharmacy of Newbern, TN.
A ruling by Judge Edward R. Korman, Eastern District Court of New York, will effectively make the Plan B® One-Step, or “morning after” contraceptive pill, available as an over-the-counter product with no age restrictions.
A bill aimed to ensure the security of pharmaceuticals in the drug supply chain has passed the United States House of Representatives.
FDA has announced the availability of grant funds intended to support the National Consumers League (NCL) in expanding efforts to educate the public about medication adherence.
FDA will allow the import of injectable drugs used in total parenteral nutrition (TPN) due to a critical shortage of the products.
Sandoz US is voluntarily recalling two lots of methotrexate sodium, USP, 25 mg/mL, 40 mL vial injectable product because of particulate matter found during a routine test of samples.
NABP expressed its support for federal legislation that would distinguish between compounding and manufacturing, in testimony presented at a United States House subcommittee hearing on May 23, 2013.
Illinois would establish a four-year medical marijuana pilot program under a bill passed by the state’s Legislature and under review by Illinois Governor Pat Quinn.
DEA has issued a final order temporarily placing three synthetic cannabinoids into Schedule I of the Controlled Substances Act (CSA).
National Association of Boards of Pharmacy ® (NABP®) has expressed its support for the Pharmaceutical Compounding Quality and Accountability Act.
Reaching a critical milestone in the generic Top-Level Domain (gTLD) approval process, the National Association of Boards of Pharmacy® (NABP®) application to own and operate the .PHARMACY domain suffix has passed the Internet Corporation for Assigned Names and Numbers (ICANN) initial evaluation.
Delegates to the National Association of Boards of Pharmacy® (NABP®) 109th Annual Meeting, held May 18-21, 2013, in St Louis, MO, elected individuals to fill the president-elect, treasurer, and open member positions on the Association’s 2013-2014 Executive Committee.
Karen M. Ryle, MS, RPh, began her term as president of the National Association of Boards of Pharmacy® (NABP® ) during the Final Business Session of the Association’s 109th Annual Meeting, May 18-21, 2013, in St Louis, MO.
Joseph L. Adams, RPh, was elected to serve as the 2013-2014 president-elect of the National Association of Boards of Pharmacy® (NABP®) during the Association’s 109th Annual Meeting, May 18-21, 2013, in St Louis, MO.
Edward G. McGinley, MBA, RPh, was elected to serve as the 2013-2014 treasurer of the National Association of Boards of Pharmacy® (NABP®) during the Association’s 109th Annual Meeting, May 18-21, 2013, in St Louis, MO.
James T. DeVita, RPh, was reelected to serve a second three-year member term, representing District 1, on the Executive Committee of the National Association of Boards of Pharmacy® (NABP®) during the Association’s 109th Annual Meeting, May 18-21, 2013, in St Louis, MO.
Susan Ksiazek, RPh, was elected to serve a three-year member term, representing District 2, on the Executive Committee of the National Association of Boards of Pharmacy® (NABP®) during the Association’s 109th Annual Meeting, May 18-21, 2013, in St Louis, MO.
Gary Dewhirst, RPh, was elected to serve a three-year member term, representing District 5, on the Executive Committee of the National Association of Boards of Pharmacy® (NABP®) during the Association’s 109th Annual Meeting, May 18-21, 2013, in St Louis, MO.
In testimony presented at a United States Senate Committee Hearing, NABP expressed its support of draft legislation that would create a new category of manufacturer to include entities that engage in large-scale production of sterile non-patient-specific drugs for distribution.
Medications produced and distributed by The Compounding Shop of St Petersburg, FL, should not be administered to patients and should be quarantined, warns FDA.
Federal lawmakers have drafted legislation that would create a new category of drug compounders, “compounding manufacturers,” to be regulated by Food and Drug Administration (FDA).
To further protect the integrity of the United States drug supply chain, the National Association of Boards of Pharmacy® (NABP®) has updated the criteria for the Association’s Verified-Accredited Wholesale Distributors® (VAWD®) accreditation program.
The National Association of Boards of Pharmacy® (NABP®) recently issued a report emphasizing that the global distribution of counterfeit and substandard medications, fueled by illegal online sellers, demands an international response.
Two pharmacies have voluntarily recalled their sterile compounded products because of concerns associated with quality control processes and a lack of sterility assurance.
The next opportunity to dispose of any unneeded or unwanted medications at a Drug Enforcement Administration (DEA) National Prescription Drug Take-Back Day collection site will be Saturday, April 27, 2013.
In a meeting last week, members of a House Energy and Commerce subcommittee stressed that Food and Drug Administration (FDA) could have done more to prevent the fungal meningitis outbreak that killed 53 people and sickened hundreds in late 2012.
FDA Commissioner Margaret A. Hamburg, MD, reported in a recent FDA blog article that agency inspectors encountered “objectionable conditions” at 30 of the 31 sterile compounding pharmacies they recently examined.
FDA is warning health care providers to quarantine and cease use of sterile drug products from ApotheCure, Inc, and NuVision Pharmacy, two Dallas, TX, facilities.
Tennessee lawmakers are considering legislation that would enable compounding pharmacies to create medicines without patient-specific prescriptions during drug shortages and other times when a product is not commercially available.
A report released by US Representative Ed Markey (D-MA) highlights the challenges states face in regulating compounding pharmacies and examines how the pharmacies are tracked and inspected.
Nevada-based Green Valley Drugs has issued a voluntary recall of all lots of all its compounded, repackaged drugs because of a lack of sterility assurance.
The Federation of State Medical Boards (FSMB) will provide a free, live Webcast Thursday, April 18, 2013, from its Annual Meeting in Boston, MA, of a panel discussion on current trends in multi-state licensure in health care.
The emergency pharmacy status reporting tool operated by Rx Response now goes by an easy-to-remember name, Rx Open, with a matching URL, www.RxOpen.org.
Fentanyl patches should be securely stored out of the sight and reach of children and disposed of properly, advises Food and Drug Administration (FDA).
United Parcel Service (UPS) agreed to forfeit $40 million in payments received from online entities illegally selling and distributing prescription drug products.
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.
With the aim of curbing prescription drug abuse, bipartisan legislation that would reclassify drug products containing hydrocodone as Schedule II controlled substances (CS) was introduced to Congress on March 20, 2013.
Med Prep Consulting, Inc, a New Jersey-based compounding pharmacy, voluntarily recalled all lots of all its compounded products after a Connecticut hospital discovered mold particles in five bags of an intravenous solution.
FDA is alerting health care providers and patients of a voluntary recall of all sterile products produced and distributed by Clinical Specialties Compounding Pharmacy (CSCP) of Augusta, GA.
With the arrival of allergy season, FDA has a released a new video to help educate patients about safe use of medications containing acetaminophen.
To protect the public health, Food and Drug Administration (FDA) should carefully consider using the exercise of enforcement discretion during drug shortages, urges NABP.
Stressing the potential danger to patients, NABP expressed its opposition to legislation introduced in Maine that would allow the dispensing of drugs from mail-order pharmacies located around the world.
Former New England Compounding Center (NECC) employees reveal how workload and facility conditions contributed to the tragic meningitis outbreak linked to the company’s contaminated drugs in a 60 Minutes segment.
Inspections of 30 entities engaged in compounding are underway by Food and Drug Administration (FDA) inspectors as part of the agency’s response to the 2012 meningitis outbreak linked to contaminated compounded injectable drugs.
Aimed to reduce prescription drug abuse and diversion, legislation that would establish an expanded PMP in Pennsylvania is under consideration by state lawmakers.
The NABP membership consists of the regulatory boards regulating the profession of pharmacy. These boards are statutorily created and empowered and act in the interest of protecting the public.
Pharmacists’ authority to vaccinate may be expanded in Wyoming under a bill that would allow pharmacists to prescribe and administer immunizations for individuals age seven and older.
New York physician Felix Rodriguez pled guilty to the distribution of more than 1,000 oxycodone pills to individuals without legitimate medical need for the drug.
Prescription drugs were involved in 60% of drug overdose deaths, which increased for the 11th consecutive year, reports Centers for Disease Control and Prevention (CDC).
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.
Cooperation among international pharmacy regulatory agencies and tightening the United States drug distribution chain would help protect global public health from substandard and falsified drugs, indicates a new report from the Institute of Medicine (IOM).
Consumers across the country will have another opportunity to help prevent abuse and misuse of prescription drugs by disposing of any unneeded or unwanted medications during the sixth Drug Enforcement Administration (DEA) National Prescription Drug Take-Back Day.
In a letter (PDF) to PharMEDium Services LLC, Food and Drug Administration (FDA) Center for Drug Evaluation and Research indicates that it will no longer exercise enforcement discretion that allowed the company to produce non-patient specific drug products for distribution to hospitals across the country.
Partial or complete cease and desist orders were issued to 11 compounding pharmacies by the Massachusetts Department of Public Health (DPH).
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.
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).
A majority of respondents to a survey on compounding practices indicated that pharmacy technicians who work in sterile compounding should be certified or licensed.
Responding to epidemic proportions of flu in New York State, Governor Andrew Cuomo has passed emergency orders expanding pharmacists’ authority to vaccinate individuals against the illness.
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.
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.
USP is seeking qualified candidates to serve on the Pharmaceutical Compounding–Sterile Preparations Expert Panel.
Andrew J. Strempler, a Canadian citizen, was sentenced to four years in prison for charges related to the operation of a Web site illegally marketing and distributing prescription drugs to US residents.
A spike in flu activity and limited supplies of vaccine and Tamiflu® doses across the country have prompted Rx Response to move its operations to Alert status.
FDA has issued new dosing recommendations for sleep aids containing zolpidem.
The Institute for Safe Medication Practices (ISMP) has launched a National Vaccine Error Reporting Program (VERP) that allows health care providers to confidentially report vaccine administration errors and near misses.
The Minnesota Board of Pharmacy, which already has strong compounding regulations and requirements in place, is in the process of considering additional requirements, some of which will require the passage of new legislation.
The California State Board of Pharmacy will sponsor a bill that would allow inspectors to make unannounced on-site inspections of certain nonresident pharmacies.
Massachusetts Governor Deval Patrick will file a bill that would strengthen the state’s regulation of compounding pharmacies.
Google has begun running search-based advertising aimed to help educate US consumers about illegal online drug sellers.
Emphasizing risks to patient safety, Food and Drug Administration (FDA) has alerted more than 350 medical practices (PDF) across the country that they may have received unapproved medications.
As FDA continues to seek a balance between minimizing opioid drug abuse and enabling the appropriate treatment of pain, the agency will hold a two-day public hearing to obtain information.
In an attempt to tighten federal oversight of compounding pharmacies in the wake of the meningitis outbreak, the S.A.F.E. Compounded Drugs Act of 2012 (HR 6638) was introduced in Congress.
Hospitals and medical centers that relied upon the NECC and its sister company, Ameridose LLC, are suffering shortages of antibiotics, pain medications, and other drugs.
Supporting state board of pharmacy efforts to enforce compounding regulations, the National Association of Boards of Pharmacy® (NABP®) is implementing a four-part action plan centered around inspection of nonresident compounding pharmacies and creating an information sharing network of regulatory details...Read More →
Additional microbial contamination has been identified in three drug products at NECC. Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) continue investigating NECC and have discovered bacteria and fungal species in unopened vials of betamethasone,...Read More →
A federal grand jury is collecting information and evidence from people who worked with the New England Compounding Center (NECC), the pharmacy that produced contaminated steroid injections leading to a multistate outbreak of fungal meningitis affecting over 540 people. The...Read More →
The Massachusetts Department of Public Health has sent cease and desist orders to three compounding pharmacies for drug preparation and storage problems that were discovered during surprise inspections. The Boston Globe reports that the issues found at the facilities –...Read More →