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Barcode Five Rights System

Use Barcode to prevent medication errors

ADERS ® is a barcode point of care, (BPOC), solution

Practical Compliance Solutions, Corp. helps care facilities reduce risk at the patient's bedside. Our five rights barcode solution is the easiest to implement. Our barcode point of care system can help prevent medication errors in hospitals, long term care facilities, and assisted living communities.

ADERS ® is our barcode solution for the healthcare industry. It helps eliminate medication errors by allowing caregivers to scan NDC barcodes at the patient's bedside, verifying right patient, right drug, right time, right dose, and right route of administration. For more information click the products menu or send us a web request from our Contact menu. Ask for a DEMO CD. It is the full product that is licensed for an evaluation period.

We are offering a 30 day no-obligation free trial of the ADERS ® software. Care facilities can easily determine if ADERS ® is right for them by using the software as a pilot for a single unit or ward. Click here to download a Microsoft Project plan showing how you can implement a five rights point of care barcode pilot in less than a week. If you Don't own MS Project 2003, then here is a PDF copy just to see.... Download Adobe PDF Data Sheet

View a PowerPoint Presentation of ADERS ®.

Get The Latest Patient Safety and Drug Safety Updates from the FDA

Food and Drug Administration--Press Releases

Criminal and civil actions filed against Aegerion Pharmaceuticals Inc.
Fri, 22 Sep 2017 17:06:00 -0400

Aegerion Pharmaceuticals Inc. agreed to plead guilty in the United States District Court for the District of Massachusetts to two misdemeanor counts of violating the Federal Food, Drug, and Cosmetic Act (FD&C Act) involving the introduction of misbranded Juxtapid (lomitapide) into interstate commerce.

Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s immediate steps to respond to Hurricane Maria and ongoing recovery efforts related to Hurricanes Harvey and Irma
Fri, 22 Sep 2017 18:26:00 -0400

Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s immediate steps to respond to Hurricane Maria and ongoing recovery efforts related to Hurricane’s Harvey and Irma

FDA clears first duodenoscope with disposable distal cap
Wed, 20 Sep 2017 11:57:00 -0400

The U.S. Food and Drug Administration today cleared the first duodenoscope with a disposable distal cap, a new feature that will improve access for cleaning and reprocessing. The Pentax ED34-i10T model duodenoscope is intended to provide visualization and access to the upper gastrointestinal (GI) tract to treat bile duct disorders and other upper GI problems.

Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s continued efforts to promote the safe adoption of medication-assisted treatment for opioid addiction
Wed, 20 Sep 2017 12:18:00 -0400

Medication-assisted treatment (MAT) – the use of medication combined with counseling and behavioral therapies – is one of the major pillars of the federal response to the opioid epidemic in this country. This type of treatment is an important tool that has the potential to help millions of Americans with an opioid use disorder regain control over their lives. In fact, patients receiving MAT cut their risk of death from all causes in half, according to the Substance Abuse and Mental Health Services Administration. Addressing the epidemic of opioid addiction is my highest public health priority. One element of that effort is promoting more widespread, safe adoption of MAT as a way to help more people overcome addiction.

FDA approves new treatment for adults with relapsed follicular lymphoma
Thu, 14 Sep 2017 12:56:00 -0400

The U.S. Food and Drug Administration today granted accelerated approval to Aliqopa (copanlisib) for the treatment of adults with relapsed follicular lymphoma who have received at least two prior treatments known as systemic therapies.

Statement from FDA Commissioner Scott Gottlieb, M.D., about crops impacted by Hurricanes Harvey and Irma and FDA’s work with farmers affected by the storms
Thu, 14 Sep 2017 13:48:00 -0400

Statement from FDA Commissioner Scott Gottlieb, M.D., about crops impacted by Hurricanes Harvey and Irma and FDA’s work with farmers affected by the storms

FDA approves first biosimilar for the treatment of cancer
Thu, 14 Sep 2017 12:11:00 -0400

The U.S. Food and Drug Administration today approved Mvasi (bevacizumab-awwb) as a biosimilar to Avastin (bevacizumab) for the treatment of multiple types of cancer. Mvasi is the first biosimilar approved in the U.S. for the treatment of cancer.

FDA permits marketing of mobile medical application for substance use disorder
Thu, 14 Sep 2017 11:16:00 -0400

Today, the U.S. Food and Drug Administration permitted marketing of the first mobile medical application to help treat substance use disorders (SUD). The Reset application is intended to be used with outpatient therapy to treat alcohol, cocaine, marijuana and stimulant SUDs. The application is not intended to be used to treat opioid dependence.

Statement from FDA Commissioner Scott Gottlieb, M.D., on a new qualified health claim advising that early introduction of peanuts to certain high-risk infants may reduce risk of peanut allergy
Thu, 07 Sep 2017 12:32:00 -0400

Statement from FDA Commissioner Scott Gottlieb, M.D., on a new qualified health claim advising that early introduction of peanuts to certain high-risk infants may reduce risk of peanut allergy

FDA clears mammography device with option for patient-assisted compression
Fri, 01 Sep 2017 15:07:00 -0400

Today, the U.S. Food and Drug Administration cleared the first 2D digital mammography system that allows patients to increase or decrease the amount of compression applied to their own breast before the mammogram x-ray is taken.

FDA approves Mylotarg for treatment of acute myeloid leukemia
Fri, 01 Sep 2017 11:19:00 -0400

The U.S. Food and Drug Administration today approved Mylotarg (gemtuzumab ozogamicin) for the treatment of adults with newly diagnosed acute myeloid leukemia whose tumors express the CD33 antigen (CD33-positive AML). The FDA also approved Mylotarg for the treatment of patients aged 2 years and older with CD33-positive AML who have experienced a relapse or who have not responded to initial treatment (refractory).

Statement from Center for Drug Evaluation and Research Director Janet Woodcock regarding safety concerns related to investigational use of Keytruda in multiple myeloma
Thu, 31 Aug 2017 11:08:00 -0400

Statement from Center for Drug Evaluation and Research Director Janet Woodcock regarding safety concerns related to investigational use of Keytruda in multiple myeloma

FDA approval brings first gene therapy to the United States
Wed, 30 Aug 2017 10:41:00 -0400

The U.S. Food and Drug Administration issued a historic action today making the first gene therapy available in the United States, ushering in a new approach to the treatment of cancer and other serious and life-threatening diseases.

FDA approves new antibacterial drug
Tue, 29 Aug 2017 17:56:00 -0400

The U.S. Food and Drug Administration today approved Vabomere for adults with complicated urinary tract infections (cUTI), including a type of kidney infection, pyelonephritis, caused by specific bacteria. Vabomere is a drug containing meropenem, an antibacterial, and vaborbactam, which inhibits certain types of resistance mechanisms used by bacteria.

FDA approves first U.S. treatment for Chagas disease
Tue, 29 Aug 2017 16:51:00 -0400

The U.S. Food and Drug Administration today granted accelerated approval to benznidazole for use in children ages 2 to 12 years old with Chagas disease. It is the first treatment approved in the United States for the treatment of Chagas disease.

Statement from FDA Commissioner Scott Gottlieb, M.D. on the FDA’s new policy steps and enforcement efforts to ensure proper oversight of stem cell therapies and regenerative medicine
Mon, 28 Aug 2017 08:56:00 -0400

One of the most promising new fields of science and medicine is the area of cell therapies and their use in regenerative medicine. These new technologies, most of which are in early stages of development, hold significant promise for transformative and potentially curative treatments for some of humanity’s most troubling and intractable maladies. Recent advances in our basic knowledge of the pathways involved in tissue damage and regeneration have combined with remarkable progress in adult stem cell biology to put us at a genuine inflection point in the history of medicine. The prospect of clinical tissue repair strategies is a tangible reality. This promise is reinforced by the strong commitment of the investment and scientific communities in exploring the potential applications across a wide range of vexing diseases and conditions, such as cancer, Parkinson’s disease, and diabetes, among many others.

FDA warns US Stem Cell Clinic of significant deviations
Mon, 28 Aug 2017 08:40:00 -0400

The U.S. Food and Drug Administration today posted a warning letter issued to US Stem Cell Clinic of Sunrise, Florida, and its Chief Scientific Officer Kristin Comella for marketing stem cell products without FDA approval and for significant deviations from current good manufacturing practice requirements, including some that could impact the sterility of their products, putting patients at risk.

FDA acts to remove unproven, potentially harmful treatment used in ‘stem cell’ centers targeting vulnerable patients
Mon, 28 Aug 2017 08:32:00 -0400

The U.S. Food and Drug Administration took decisive action to prevent the use of a potentially dangerous and unproven treatment belonging to StemImmune Inc. in San Diego, California, and administered to patients at the California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills, California. On behalf of the FDA, on Friday, Aug. 25, 2017 the U.S. Marshals Service seized five vials of Vaccinia Virus Vaccine (Live) – a vaccine that is reserved only for people at high risk for smallpox, such as some members of the military. Each of the vials originally contained 100 doses of the vaccine, and although one vial was partially used, four of the vials were intact.

Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s role in ensuring Americans have access to clear and consistent calorie and nutrition information; forthcoming guidance will provide greater clarity and certainty
Fri, 25 Aug 2017 09:29:00 -0400

As a doctor, father and the head of the U.S. Food & Drug Administration, I believe that everyone is entitled to the information they need to make informed decisions about the food they eat. We serve as the nation’s expert on food labeling, which is why Congress entrusted us with the responsibility of crafting predictable, uniform federal standards that will benefit the health of families across America by ensuring access to essential calorie and nutrition information on food and menu labels.

Statement from FDA Commissioner Scott Gottlieb, M.D. – FDA is carefully evaluating prescription opioid medications approved to treat cough in children
Mon, 21 Aug 2017 09:31:00 -0400

There’s perhaps no more important mandate that we have at the FDA than safeguarding the health and safety of children. For that reason, I believe it’s important that parents and health care providers have the best information available to inform the decisions they make about a child’s health. There are few more common decisions that parents and providers are asked to make than the question of how to appropriately treat a child’s cough and cold symptoms. Sometimes symptoms can be severe enough that prescription medication is needed, but some of these medications pose their own risks – especially for younger children – because they may contain opioids. Other times medication might not be necessary at all.

Food and Drug Administration--Recalls/Safety Alerts

America New York Ri Wang Food Group Issues Allergy Alert on Seafood Products
Sat, 23 Sep 2017 12:51:00 -0400

America New York Ri Wang Food Group Co. ltd is recalling the following products because an allergenic ingredient, milk, was not declared in labelling. People who have an allergy or severe sensitivity to milk run the risk of serious of life-threatening allergic reaction if they consume these products.

First Source Issues Allergy Alert On Undeclared Milk In Tasty Treats Nonpareils Milk Chocolate
Wed, 20 Sep 2017 21:16:00 -0400

First Source of Pico Rivera, CA, is recalling Tasty Treats Nonpareils Milk Chocolate because it contains undeclared milk. People who have an allergy or severe sensitivity to Milk run the risk of serious or life-threatening allergic reaction if they consume this product.

Nature Supplement Inc. Issues Voluntary Florida Recall of Vegetable Vigra Due to Undeclared Sildenafil
Wed, 20 Sep 2017 16:49:00 -0400

Natures Supplement, Inc. is voluntarily recalling 260 bottles of VEGETABLE VIGRA, 200 mg capsules to the consumer level. FDA analysis found this product to be tainted with Sidenafil. Sildenafil is an FDA approved drug for the treatment of erectile dysfunction, the presence of Sildenafil in the Vegetable Vigra product renders it an unapproved drug for which safety and efficacy has not been established, therefore subject to recall.

Death Wish Coffee Co. Announces Recall of Nitro Cold Brew Cans From Retailers, Online Sales
Wed, 20 Sep 2017 16:02:00 -0400

Death Wish Coffee Co. (“Death Wish”), the Round Lake, N.Y.-based coffee producer known for producing the ‘World’s Strongest Coffee’, has initiated a recall its 11-oz Death Wish Nitro Cold Brew cans.

Gadget Island, Inc. Dba Gear Isle Issues Voluntary Nationwide Recall of Dietary Supplements Due to Undeclared Active Pharmaceutical Ingredients.
Wed, 20 Sep 2017 14:58:00 -0400

Newark, CA, Gadget Island, Inc. is voluntarily recalling to the consumer level. The products have been found to contain undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.

Natural Grocers Issues Recall on Organic Deglet Dates Due to Mislabeling and Undeclared Allergens
Thu, 14 Sep 2017 11:51:00 -0400

Vitamin Cottage Natural Food Markets, Inc., a Lakewood, Colorado-based natural grocery chain, is recalling Natural Grocers brand Organic Deglet Noor Dates Pitted because it may contain undeclared coconut, an allergen. People who have an allergy or severe sensitivity to coconut run the risk of a serious or life-threatening allergic reaction if they consume this product.

OriGen Biomedical Issues Nationwide Recall of OriGen VV28F Reinforced Dual Lumen ECMO Catheters
Tue, 12 Sep 2017 21:10:00 -0400

On August 2, 2017, OriGen Biomedical initiated a nationwide recall for two (2) lots of VV28F Reinforced Dual Lumen ECMO Catheters. These VV28F Reinforced Dual Lumen ECMO Catheters have been found to have the potential for a separation of the clear extension tube from the hub that it is inserted in, which potentially could result in required intervention to prevent permanent impairment/damage.

Cherry Valley Marketplace Issues Allergy Alert on Undeclared Milk Allergens in “Cherry Valley Vanilla Cupcakes” and “Cherry Valley Chocolate Cupcakes”
Tue, 12 Sep 2017 19:01:00 -0400

Cherry Valley Marketplace, West Hempstead, NY, is recalling its 12-ounce packages of CHERRY VALLEY VANILLA CUPCAKES and CHERRY VALLEY CHOCOLATE CUPCAKES because they may contain undeclared milk allergens. Consumers who are allergic to milk allergens may run the risk of serious or life-threatening allergic reactions if they consume this product.

Medtronic Announces Voluntary Recall of Diabetes Infusion Sets
Tue, 12 Sep 2017 15:20:00 -0400

Medtronic plc (NYSE:MDT) announced today that it has started to inform patients worldwide of a voluntary recall of specific lots of infusion sets used with all models of Medtronic insulin pumps. The recall is related to a certain discontinued component in these infusion sets and does not include insulin pumps or glucose sensors.

Bravo Produce Inc. Retira Maradol Papaya de Productores y Exportadores de Carica Papaya de Tecomán y Costa Alegre SPR de RL y empacadas por Frutas Selectas de Tijuana, S. de R.L. de C.V. Por posible riesgo a la salud
Tue, 12 Sep 2017 11:56:00 -0400

Bravo Produce Inc de San Ysidro, está retirando Maradol Papaya, cultivadas por Productores y Exportadores de Carica Papaya de Tecoman y Costa Alegre SPR de RL y empacadas por Frutas Selectas de Tijuana, S. de R.L. de C.V., como manera preventiva, debido a que dicho producto ha probado positivo para Salmonella, es de suma importancia mencionar que dicha bacteria puede afectar a niños, ancianos y personas con sistemas inmunológicos débiles. Los síntomas a experimentar son fiebre, diarrea, náusea, vómito y dolor abdominal. En raras circunstancias, la infección por Salmonella puede resultar en el organismo entrando en el torrente sanguíneo y la producción de enfermedades graves, como las infecciones arteriales (es decir, los aneurismas infectados), endocarditis y artritis.

Coborn’s, Inc.’s Issues Recall of American Rye Bread and Caraway Rye Bread Due To Undeclared Allergens
Mon, 11 Sep 2017 11:53:00 -0400

Coborn's, Inc. is recalling packages of its American Rye Bread and Caraway Bread, which contain undeclared allergens (milk, soy and egg) as a result of an update to the ingredient profile from the manufacturer of the base. People who have an allergy or severe sensitivity to Milk, Soy, and/or Eggs run the risk of serious or life-threatening allergic reaction if they consume these products.

Bravo Produce Inc. Recalls Maradol Papaya from Productores Y Exportadores De Carica Papaya De Tecomán Y Costa Alegre SPR of RL and Packed by Frutas Selectas De Tijuana, S. De R.L. De C.V. Because of Possible Health Risk
Sun, 10 Sep 2017 16:14:00 -0400

Bravo Produce Inc. of San Ysidro, is withdrawing Maradol Papaya, grown by Productores y Exportadores de Carica Papaya de Tecomán y Costa Alegre SPR of RL and packed by Frutas Selectas de Tijuana, S. de RL de CV, as a preventive measure, because the product has tested positive for Salmonella by exams done by FDA. It is extremely important to mention that this bacterium can affect children, elderly and people with weak immune systems. Symptoms are fever, diarrhea, nausea, vomiting and abdominal pain.

Simply Fresh Foods, Inc. Issues Allergy Alert on Undeclared Milk in Single Serve Cups of San Francisco Seafood Salad Made with Greek Yogurt
Fri, 08 Sep 2017 19:52:00 -0400

Simply Fresh Foods, Inc. of Buena Park, CA is recalling 272 cases of one specific lot of its 4-4 ounce packages of "San Francisco Seafood Salad Made with Greek Yogurt" bearing a UPC bar code of 47502 19701 because the individual cups inside the carton may be mislabeled as Seafood Salad with Real Mayonnaise and does not declare "milk". The outer carton is correct and has the correct ingredient statement which declares "milk". People who have allergies to milk run the risk of serious or life-threatening allergic reaction if they consume this product.

Garden of Life LLC Issues Recall of Baby Organic Liquid Formula
Fri, 08 Sep 2017 09:49:00 -0400

Today, Garden of Life, LLC, is issuing a voluntary precautionary recall of its new supplement for infants, Baby Organic Liquid, because the product, as labeled, includes directions for use that may be misinterpreted. The company is concerned that if not administered precisely following the labeled instructions, the product may present difficulties in swallowing and potentially pose a choking hazard due to the thickness of the liquid.

Product Recall By Wegmans Of Assorted Muffins 4 Pack
Thu, 07 Sep 2017 13:53:00 -0400

The assorted muffin four pack may include a banana nut muffin containing walnuts, an allergen not listed on the label. People who have an allergy or sensitivity to nuts should not consume this product.

Genentech Issues Voluntary Nationwide Recall of Three Lots of Activase® (Alteplase)-100 mg Due to Lack of Sterility Assurance of the Sterile Water for Injection
Wed, 06 Sep 2017 21:47:00 -0400

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), is voluntarily recalling three lots of Activase® (alteplase) 100mg vials, that were co-packaged with Sterile Water for Injection, to the hospital level. The vials of Sterile Water for Injection, manufactured by Hospira Inc., a Pfizer company, and packaged with Activase 100 mg, may be cracked or chipped at the neck of the vial and leaking.

Country Fresh Orlando LLC, Recalls Product Because of Possible Health Risk
Tue, 05 Sep 2017 11:40:00 -0400

Country Fresh Orlando, LLC. of Orlando, Florida, is recalling 5,999 cases of diced bell pepper, vegetable kabobs, and creole and fajita mixed diced vegetables (product descriptions attached), because they have the potential to be contaminated with Listeria monocytogenes. Listeria monocytogenes is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

Wakefern Food Corp. Voluntarily Recalls ShopRite Semi-Sweet Real Chocolate Chips
Fri, 01 Sep 2017 19:10:00 -0400

Wakefern Food Corp. has initiated a voluntary recall of its ShopRite brand Semi-Sweet Real Chocolate Chips. The chips were sold in 24 oz. bags bearing a UPC bar code of 041190 02668 and Best if Used By dates of April 11, 2019 and April 12, 2019.

PharMEDium Services, LLC Issues Voluntary Nationwide Recall of all unexpired lots of Oxytocin Compounded with Either Lactated Ringers or Lactated Ringers and Dextrose Due to Sub-Potency
Fri, 01 Sep 2017 15:15:00 -0400

PharMEDium Services, LLC (PharMEDium) is voluntarily recalling all unexpired lots of Oxytocin compounded with Lactated Ringers and all unexpired lots of Oxytocin compounded with Lactated Ringers and Dextrose products that were produced between July 6, 2017 and August 29, 2017 to the hospital/user level. The recall is being issued based on laboratory test results indicating a lower than expected potency on certain lots of Oxytocin compounded with Lactated Ringers and Oxytocin Compounded with Lactated Ringers and Dextrose which would lead to a lower dose being administered.

Hospira Issues Voluntary Worldwide Recall For Lots of Hydromorphone HCl Injection, USP, CII, (2 mg/mL) 1mg/mL Vial, and Levophed® (Norepinephrine Bitartrate Injection, USP), 4 mg/4 mL (1 mg/mL) Vial, Due to a Lack of Sterility Assurance
Fri, 01 Sep 2017 10:22:00 -0400

Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of Hydromorphone HCI Injection, USP, CII (2 mg/mL) 1mg/mL Vial and four lots of Levophed® (Norepinephrine Bitartrate Injection, USP), 4 mg/4 mL (1 mg/mL) Vial due to a potential lack of sterility assurance resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process. To date, Hospira, Inc., a Pfizer company has not received any reports of adverse events related to this recall.

What's New: Drugs RSS Feed

Medication Guides
Fri, 22 Sep 2017 11:50:00 -0400

Updated list of medication guides.

Newly Added Guidance Documents
Fri, 22 Sep 2017 08:22:00 -0400



Natural Disaster Preparedness and Response
Thu, 21 Sep 2017 14:43:00 -0400



FDA Drug Safety Communication: FDA warns about serious liver injury with Ocaliva (obeticholic acid) for rare chronic liver disease
Thu, 21 Sep 2017 09:43:00 -0400

The Food and Drug Administration (FDA) is warning that the liver disease medicine Ocaliva (obeticholic acid) is being incorrectly dosed in some patients with moderate to severe decreases in liver function, resulting in an increased risk of serious liver injury and death.

Spectrum of Diseases/Conditions
Thu, 21 Sep 2017 08:40:00 -0400

Updated list.

Pediatric Exclusivity Statistics
Thu, 21 Sep 2017 08:34:00 -0400

Updated list.

FDA Drug Safety Communication: FDA urges caution about withholding opioid addiction medications from patients taking benzodiazepines or CNS depressants: careful medication management can reduce risks
Wed, 20 Sep 2017 13:59:00 -0400

Based on our additional review, the U.S. Food and Drug Administration (FDA) is advising that the opioid addiction medications buprenorphine and methadone should not be withheld from patients taking benzodiazepines or other drugs that depress the central nervous system (CNS). The combined use of these drugs increases the risk of serious side effects; however, the harm caused by untreated opioid addiction usually outweighs these risks. Careful medication management by health care professionals can reduce these risks. We are requiring this information to be added to the buprenorphine and methadone drug labels along with detailed recommendations for minimizing the use of medication-assisted treatment (MAT) drugs and benzodiazepines together.

FDA Drug Safety Communication: FDA warns about serious risks and death when combining opioid pain or cough medicines with benzodiazepines; requires its strongest warning
Wed, 20 Sep 2017 11:31:00 -0400

[8-31-2016] A U.S. Food and Drug Administration (FDA) review has found that the growing combined use of opioid medicines with benzodiazepines or other drugs that depress the central nervous system (CNS) has resulted in serious side effects, including slowed or difficult breathing and deaths.

Prescription to Over-the-Counter (OTC) Switch List
Wed, 20 Sep 2017 09:45:00 -0400



Drugs@FDA Data Files
Tue, 19 Sep 2017 14:36:00 -0400

Data files updated through September 19, 2017.

Drugs@FDA Download File (new structure)
Tue, 19 Sep 2017 14:34:00 -0400

Data files updated through September 19, 2017.

Dermatologic and Ophthalmic Drugs Advisory Committee Roster
Tue, 19 Sep 2017 13:36:00 -0400

This page contains the DODAC roster, which lists the current members and the current number of vacancies for the committee.

Q4B Annex 8: Sterility Test General Chapter
Mon, 18 Sep 2017 13:38:00 -0400

International Council on Harmonisation - Quality

Q4B Annex 9: Tablet Friability General Chapter
Mon, 18 Sep 2017 13:31:00 -0400

International Council on Harmonisation - Quality

Q4B Annex 5: Disintegration Test General Chapter
Mon, 18 Sep 2017 13:29:00 -0400

International Council on Harmonisation - Quality

FDA Adverse Event Reporting System (FAERS): Latest Quarterly Data Files
Wed, 13 Sep 2017 14:54:00 -0400

FDA Adverse Event Reporting System (FAERS) - Quarterly Data Extract (QDE): The Quarterly Data Extract files, contain raw data extracted from the FAERS database for the indicated time ranges (not cumulative), in ASCII or SGML formats.

Pulmonary-Allergy Drugs Advisory Committee Roster
Wed, 13 Sep 2017 14:36:00 -0400

This page contains the Pulmonary-Allergy Drugs Advisory Committee roster, which lists the current members and the current number of vacancies for the committee.

Additions/Deletions for Prescription and OTC Drug Product Lists
Wed, 13 Sep 2017 12:06:00 -0400

The list has been updated through July 2017.

Orange Book Zip File
Wed, 13 Sep 2017 12:02:00 -0400

August 2017 Orange Book data files, ZIP format.

La FDA recomienda separar las dosis de sulfonato de poliestireno sódico (Kayexalate) para reducir los niveles de potasio, de las de todo otro medicamento oral
Mon, 11 Sep 2017 10:22:00 -0400



What's New: Vaccines, Blood & Biologics RSS Feed

Privigen
Tue, 19 Sep 2017 14:57:00 -0400



Abbott Prism Chagas
Mon, 11 Sep 2017 13:32:00 -0400

The ABBOTT PRISM Chagas assay is an in vitro chemiluminescent immunoassay (ChLIA) for the qualitative detection of antibodies to Trypanosoma cruzi (T cruzi), the causative agent of Chagas disease, in human serum and plasma specimens.

WinRho SDF Liquid
Fri, 08 Sep 2017 10:11:00 -0400

Updated Package Insert, Patient Information and "Dear Healthcare Provider" Letter with Drug Warning Information. Updated: January 26, 2010.

Diphtheria and Tetanus Toxoids Adsorbed
Mon, 28 Aug 2017 14:10:00 -0400



Benefix
Mon, 28 Aug 2017 13:17:00 -0400



ReFacto
Mon, 28 Aug 2017 11:12:00 -0400




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