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Citing a global health crisis permeating an international marketplace, United States Pharmacopeial Convention announced that it would be joining the Fight the Fakes campaign.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 →
Following the signing of the Drug Quality and Security Act on November 27, 2013, Food and Drug Administration (FDA) has provided implementation information on Title I of the law – known as the Compounding Quality Act – through its Web site.Read More →
Three draft guidance documents related to the Drug Quality and Security Act have been made available on the FDA Web site for comment.Read More →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 →
The Arkansas Prescription Monitoring Program (PMP) has deployed NABP PMP InterConnect®, bringing the total number of live participating state PMPs to 21.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 →