• Microorganisms
  • The severity of the effects that microorganisms may have on any particular drug product is a function of the nature of the product, its intended use, and the nature of the microorganism concerned. (scribd.com)
  • In either situation, or in any related situation, the presence of microorganisms ought to be avoided in drug products . (scribd.com)
  • The authors cultured microorganisms, if present, from the 0.2-┬Ám filter unit and from the residual contents of the syringes used for drawing up or administering drugs. (asahq.org)
  • The authors collected used syringes at the end of each case and grew microorganisms from residual drug in 55 of these 2,318 (2.4%) syringes including all the aforementioned microorganisms and also Kocuria kristinae , Staphylococcus aureus , and Staphylococcus hominus . (asahq.org)
  • Microorganisms with the potential to cause infection are being injected (presumably inadvertently) into some patients during the administration of intravenous drugs by bolus during anesthesia. (asahq.org)
  • batches of the drug
  • Indian pharmaceutical company Ranbaxy Laboratories confirmed that it will be stopping the production of its generic version of cholesterol drug Lipitor until its investigation into the presence of glass materials in some batches of the drug is completed. (medindia.net)
  • For example, if the firm finds a leaking pipe near a product assembly line and tests for batches of the drug produced on that line are positive for contamination, they would submit that as the reason to how they believe their products came to be affected. (wikipedia.org)
  • sterile
  • The FDA is advising healthcare professionals and consumers against the use of drugs marketed as sterile by Downing Labs LLC, also known as NuVision Pharmacy in Dallas, TX, as they may be contaminated. (empr.com)
  • The FDA inspected NuVision and observed insanitary conditions that result in a lack of sterility assurance of purportedly sterile drug products produced by the company. (empr.com)
  • The inspection revealed sterility failures in 19 lots of drug products intended to be sterile, endotoxin failures in three lots of drug products, and inadequate or no investigation of these failures. (empr.com)
  • Administration of non-sterile drug products intended to be sterile may result in serious and potentially life-threatening infections or death. (empr.com)
  • Healthcare professionals should immediately check their medical supplies, quarantine any sterile drug products from NuVision, and not administer them to patients. (empr.com)
  • recall
  • An Illinois-based dog food company has expanded its recall due to concerns of possible contamination by a drug that is used for euthanasia. (foxnews.com)
  • Ranbaxy had initiated a voluntary recall of its generic atorvastatin drug after it was informed by one of its suppliers that there could be a possibility that the drug could have been contaminated by glass materials. (medindia.net)
  • Last week, Rugby Laboratories issued a voluntary nationwide recall of all lots of two liquid docusate sodium laxatives, Diocto Liquid and Diocto Syrup, made by PharmaTech due to possible Burkholderia cepacia contamination. (raps.org)
  • A drug recall removes a prescription or over-the-counter drug from the market. (wikipedia.org)
  • When a drug recall is made, the drug is removed from the market and potential legal action can be taken depending on the severity of the drug recall. (wikipedia.org)
  • This graph charts the rise in drug recalls by class in the United States from 2004 to 2014 with data from Regulatory Affairs Professionals Society The recall process in the United States follows three approximate phases. (wikipedia.org)
  • A firm submitting a recall to the FDA must provide all relevant information about the specific drug, including but not limited to: product name, use, description, and at least two samples of product (including packaging, instructions, inserts, etc. (wikipedia.org)
  • food
  • Nanowerk News ) Following the U.S. Food and Drug Administration's recent decision to participate in the inspection of overseas drug-manufacturing facilities, the pharmaceutical industry is reexamining its approach to quality control. (nanowerk.com)
  • GLENVIEW, Ill. - Mead Johnson Nutrition over the holidays conducted a new round of testing on samples of a batch of Enfamil Premium Newborn powdered formula related to a Food and Drug Administration investigation. (drugstorenews.com)
  • While there have been no reports of any harm caused to its users, the US Food and Drug Administration revealed that Ranbaxy had informed that it will be ceasing the production of the drug until its investigation is complete. (medindia.net)
  • What's less well-known is that each year, hundreds of new inventions are produced in the laboratories of NIH, the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA), and these inventions are licensed out to private companies in the US and internationally for further research and development, with the hopes of bringing new products to market. (raps.org)
  • The US Food and Drug Administration (FDA) on Friday issued draft guidance detailing a risk-based framework for drugs and biologics containing nanomaterials or made using nanotechnology. (raps.org)
  • The US Food and Drug Administration (FDA) on Monday released new draft guidance outlining how it will take a new risk-based enforcement approach to drug products labeled as homeopathic. (raps.org)
  • In the United States, current Good Manufacturing Practice (cGMP) regulations are issued by the U.S. Food and Drug Administration (FDA) as the minimum requirements for quality systems for FDA-regulated products such as food, drugs, biologics and devices. (scribd.com)
  • This legislation will allow (U.S. Food and Drug Administration) to require higher standards for certain drugs and better protect the public health. (blogspot.com)
  • Compounders will have the opportunity to register as outsourcing facilities subject to oversight by the U.S. Food and Drug Administration in much the same way as traditional manufacturers are monitored. (blogspot.com)
  • This food processor replaced his aeromechanical conveyors with the Hapman Series "C" Tubular Drag Conveyors. (hapman.com)
  • Nery claimed he had failed the drug test due to food contamination. (wikipedia.org)
  • In August, 2004 the US Food and Drug Administration (USFDA) determined zinc-DTPA and calcium-DTPA to be safe and effective for treatment of those who have breathed in or otherwise been contaminated internally by plutonium, americium, or curium. (wikipedia.org)
  • In the United States, it is regulated by the U.S. Food and Drug Administration (FDA), and may only be lawfully distributed by order of a licensed veterinarian. (wikipedia.org)
  • In September 2012, the Centers for Disease Control and Prevention, in collaboration with state and local health departments and the Food and Drug Administration (FDA), began investigating a multistate outbreak of fungal meningitis and other infections among patients who had received contaminated steroid injections from the New England Compounding Center (NECC) in Framingham, Massachusetts. (wikipedia.org)
  • On November 14, 2012, members of a congressional committee investigating the outbreak accused the Food and Drug Administration (FDA) of failing to prevent the crisis by moving too slowly against the Massachusetts pharmacy. (wikipedia.org)
  • Furthermore, many officials and government departments, namely, the U.S. Food and Drug Administration, have fallen victim to regulatory capture. (wikipedia.org)
  • The book goes on to state that the Pure Food and Drug Act of 1906 is not effective in arresting these trends, and real reform or consumer protection is obstructed by the powerful connections that offending corporations have with the government. (wikipedia.org)
  • The book argues that many products would not be sold if properly labeled, and this failure to police product labeling has been a key failing of the Food and Drug Administration. (wikipedia.org)
  • Extensive reform and overhaul in government regulation and inspection of the food and drug industry is needed in order to adequately protect consumers from corporations and manufacturers who do not place the health of the consumer before profit. (wikipedia.org)
  • Currently, the only drug approved by the Food and Drug Administration to treat radionuclide contamination is diethylenetriaminepentaacetic acid (DTPA) (Figure 1). (wikipedia.org)
  • Drug quality is primarily controlled by the National Agency for Food and Drug Administration and Control (NAFDAC). (wikipedia.org)
  • purity
  • ASPEX is a leading provider of integrated solutions for a wide range of critical cleanliness, microcontamination analysis, product purity, contamination diagnostics, predictive maintenance, and other process control initiatives incorporating scanning electron microscopes and elemental analysis technologies. (nanowerk.com)
  • Finally, in a separate study, Abergel evaluated the purity of this molecule for potential drug applications, ultimately bringing this effort closer to the development of a deployable treatment solution. (wikipedia.org)
  • Litigation
  • KCT obtains exceptional results in a variety of cases involving class actions, personal injuries, dangerous drugs, defective medical devices, wage and hour claims, and complex litigation. (martindale.com)
  • News
  • Rather than take off for Christmas, the editors of Drug Store News took a look at the year ahead and the stories, issues and trends that will make headlines in retail pharmacy in 2012. (drugstorenews.com)
  • According to Drug Store News blogger Moira Koch, those retailers engaging m-commerce with e-coupons and daily deals will reap the benefits with increased loyalty and traction. (drugstorenews.com)
  • authority
  • FDA will know who these outsourcers are and what they are making, receive adverse event reports about compounded drugs and have the authority and resources to conduct risk-based inspections. (blogspot.com)
  • The Drug Quality and Security Act (H.R. 3204), a bill to grant the FDA more authority to regulate and monitor the manufacturing of compounding drugs, was passed by the Senate on November 27, 2013. (wikipedia.org)
  • In 1985, Baron & Budd filed suit on behalf of more than 1,600 Tucson-area residents against an aircraft manufacturer, the City of Tucson, and the Tucson Airport Authority over trichloroethylene (TCE) contamination of the community's groundwater. (wikipedia.org)
  • product
  • Today, we are taking a critical step forward in securing the safety of our drug supply chain by creating a product tracing system and improving the quality of compounded drugs, which unfortunately have operated in the past under a faulty law," Pallone said. (blogspot.com)
  • First, the cables were continually fraying and breaking - putting small metallic fragments into their product, which caused a tremendous amount of product contamination and rejection. (hapman.com)
  • Drugs and medical devices are typically recalled if the product is defective, contaminated, contains a foreign object, fails to meet specifications, mislabeled, or misbranded. (wikipedia.org)
  • counterfeit
  • Because counterfeit or contaminated drugs can result in allergic reactions or even death (as evidenced by the widely-publicized heparin epidemic), the Rx's ability to identify harmful particles as small as 30 nanometers yields far-reaching effects for consumer safety. (nanowerk.com)
  • There is currently no system for tracking the drugs that make up some four billion prescriptions per year in the U.S. which means drugs that are stolen or counterfeit may not be discovered before reaching consumers, Pallone said. (blogspot.com)
  • Health
  • Erin Fox, director of drug information the University of Utah Health Care told Focus that this lack of information makes it difficult to respond to such advisories. (raps.org)
  • A new U.S. Congressional bill that would help ensure the safety of compounded drugs and the nation's pharmaceutical supply chain deserves support, said U.S. Rep. Frank J. Pallone Jr., D-N.J., the top Democrat on the House Energy and Commerce Health Subcommittee. (blogspot.com)
  • Class II recalls refer to drugs that induce temporary and/or medically reversible health effects. (wikipedia.org)
  • After that time has elapsed both calcium-DTPA and zinc-DTPA are similarly effective in reducing internal contamination with plutonium, americium or curium, and zinc-DTPA is less likely to deplete the body's normal levels of zinc and other metals essential to health. (wikipedia.org)
  • On October 9, 2012, members of the United States Congress asked federal health officials for briefings on the outbreak as a first step toward possible legislative action to strengthen federal drug safety regulations. (wikipedia.org)
  • In Sweden, the industry together with universities and health care sector has developed a method for environmental risk assessment and environmental classification of drugs. (wikipedia.org)
  • control
  • Consistent quality control is critical to the safe and successful globalization of drug production, as well as developing and implementing new analytical methodologies to support emerging 'Quality by Design' initiatives," said Dr. Marie Vicens, Application Specialist at ASPEX and guest speaker at the 50th Rocky Mountain Conference on Analytical Chemistry. (nanowerk.com)
  • 5 - 7 Case series reports, retrospective analyses of clinical trials, and case-control studies have shown alkylating agents and topoisomerase-II inhibitors to cause leukemias and other tumors in patients receiving these drugs for the treatment of malignant or nonmalignant conditions. (ajhp.org)
  • pharmaceutical
  • The book takes particular aim at the pharmaceutical market in the United States during the period, citing extensive lists of drugs which are often the subject of very strong and widespread campaigns of media promotion as "wonder-drugs," yet which do not have any effect on the conditions they purport to cure, and often carry with them serious side effects that are not revealed to consumers. (wikipedia.org)
  • investigation
  • In October 2012, an investigation of the NECC revealed the company had been in violation of its state license because it had been functioning as a drug manufacturer, producing drugs for broad use rather than filling individual prescriptions. (wikipedia.org)
  • metabolism
  • Another, though less noticed controversy he started by expressing his view that drug metabolism is wasted and called for the development of metabolism-resistant drugs. (wikipedia.org)
  • voluntary
  • Drug recalls can be initiated by the producing firm or the FDA, and those launched by the FDA can be either mandatory or voluntary. (wikipedia.org)
  • products
  • This is applicable not just to drugs but all products covered under the FDA. (wikipedia.org)
  • The authors also question the value of statements made by scientists who vouch for the safety of products, citing the example of a dean of the College of Pharmacy of Columbia University who had vouched for the safety of a drug that later proved fatal to many. (wikipedia.org)
  • Pharmacy
  • The bill also would create a uniform framework for tracking drugs from the manufacturer to the pharmacy. (blogspot.com)
  • levels
  • though this has been contested legally in a number of U.S. states as a standard of what constitutes 'unusual' levels of contamination remains to be achieved (see below). (wikipedia.org)
  • 3204
  • Pallone co-authored the bipartisan Drug Quality and Security Act or H.R. 3204, which was developed partly in response to last year's meningitis outbreak in Massachusetts caused by contaminated compounded drugs mixed at the New England Compounding Center, which killed 64 people and sickened 750 more, said Pallone in a release. (blogspot.com)
  • specific
  • These are mainly substances of natural origin, which are known to be liable to contamination usually with specific organisms. (scribd.com)
  • Compounding pharmacies mix drugs tailored to specific patient needs. (blogspot.com)
  • Such pharmacies are authorized to combine, mix, or alter ingredients to create specific formulations of drugs to meet the specific needs of individual patients, and only in response to individual prescriptions. (wikipedia.org)
  • manufacture
  • The regulation was also meant to limit the manufacture and import of fake or sub-standard drugs and to curtail false advertising. (wikipedia.org)
  • result
  • Preparation of fluorouracil outside the BSC using the CSTD did not result in significant analytically detectable contamination on the countertops. (ajhp.org)
  • regulation
  • From most to least severe, there is Class I, Class II, and Class III (defined above).There is also market withdrawal which occurs when a drug does not violate FDA regulation but has a known, minor default. (wikipedia.org)
  • high
  • The Hapman Series "C" Tubular Drag Conveyor which uses a high strength, stainless steel log chain. (hapman.com)
  • This estimate of contamination could be as high as 94%, according to Bill and Rich Sones of the Chicago Sun-Times. (wikipedia.org)
  • This may be attributed to intense competition, absence of North American Free Trade Agreement (NAFTA) parity, drug contamination delaying deliveries, and the high cost of operation, including security costs. (wikipedia.org)
  • source
  • It was uncovered in the Sacramento Bee that while the initial source of the contamination comes from money used in the Illegal drug trade in circulation, the U.S. Federal Reserve unwittingly spreads the substance to clean currency by mixing the notes together. (wikipedia.org)
  • effective
  • Our proven record of effective advocacy in our class action, dangerous drugs and defective medical device cases, in both federal and state courts, earned KCT court-appointed positions as lead counsel and co-lead counsel. (martindale.com)
  • The recommended treatment is for an initial dose of calcium-DTPA, as this salt of DTPA has been shown to be more effective in the first 24 hours after internal contamination by plutonium, americium, or curium. (wikipedia.org)
  • In 1989 legislation made effective a list of essential drugs. (wikipedia.org)
  • cause
  • Ranbaxy decided to stop making atorvastatin until the company has thoroughly investigated the cause of the contamination and remedied the problem. (medindia.net)
  • Hazardous drugs (HDs) can cause irritation or damage to the skin, eyes, or mucous membranes. (ajhp.org)
  • The discovery that cocaine is so prevalent in U.S. banknotes has a legal application that reactions by drug-sniffing dogs is not immediately cause for arrest of persons or confiscation of banknotes. (wikipedia.org)
  • manufacturer
  • Current federal regulations require that a drug be labeled with the name and place of business of the manufacturer, packager or distributor. (raps.org)
  • standard
  • The use of a CSTD in the BSC in conjunction with standard HD preparation techniques significantly reduced cyclophosphamide surface contamination as compared to standard techniques alone. (ajhp.org)