Barcode Five Rights System



Use Barcode to prevent medication errors



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

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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 ®.





Current Patient Safety and Drug Safety Updates from the FDA


FDA Press Releases RSS Feed

Coronavirus (COVID-19) Update: Daily Roundup April 3, 2020
Fri, 03 Apr 2020 18:18:53 EDT

  Coronavirus (COVID-19) Update: Daily Roundup

Coronavirus (COVID-19) Update: FDA Coordinates National Effort to Develop Blood-Related Therapies for COVID-19
Fri, 03 Apr 2020 13:04:41 EDT

  N/A

Coronavirus (COVID-19) Update: Daily Roundup April 2, 2020
Thu, 02 Apr 2020 18:56:10 EDT

  Coronavirus (COVID-19) Update: Daily Roundup

Coronavirus (COVID-19) Update: FDA Provides Updated Guidance to Address the Urgent Need for Blood During the Pandemic
Thu, 02 Apr 2020 11:55:05 EDT

  Coronavirus (COVID-19) Update: FDA Provides Updated Guidance to Address the Urgent Need for Blood During the Pandemic

Coronavirus (COVID-19) Update: Daily Roundup April 1, 2020
Wed, 01 Apr 2020 20:35:56 EDT

  Coronavirus (COVID-19) Update: Daily Roundup

FDA Approves Additional Treatment for Adults and Adolescents with Hemophilia A or B and Inhibitors
Wed, 01 Apr 2020 13:42:54 EDT

  FDA approves treatment for the control of bleeding episodes occurring in adults and adolescents 12 years of age and older with hemophilia A or B with inhibitors.

FDA Requests Removal of All Ranitidine Products (Zantac) from the Market
Wed, 01 Apr 2020 10:51:43 EDT

  The FDA announces that it is requesting manufacturers withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market immediately

Coronavirus (COVID-19) Update: Daily Roundup March 31, 2020
Tue, 31 Mar 2020 22:26:15 EDT

  Coronavirus (COVID-19) Update: Daily Roundup

Coronavirus (COVID-19) Update: FDA Continues to Accelerate Development of Novel Therapies for COVID-19
Tue, 31 Mar 2020 15:48:07 EDT

  FDA has stood up a new program to expedite the development of potentially safe and effective life-saving treatments for COVID-19.

Coronavirus (COVID-19) Update: Daily Roundup March 30, 2020
Mon, 30 Mar 2020 17:57:50 EDT

  Coronavirus (COVID-19) Update: Daily Roundup

Coronavirus (COVID-19) Update: FDA expedites review of diagnostic tests to combat COVID-19
Mon, 30 Mar 2020 10:47:57 EDT

  : Coronavirus (COVID-19) Update: FDA expedites review of diagnostic tests to combat COVID-19

FDA on Signing of the COVID-19 Emergency Relief Bill, Including Landmark Over-the-Counter Drug Reform and User Fee Legislation
Mon, 30 Mar 2020 09:41:00 EDT

  The President signed into law a $2 trillion emergency relief bill that will continue to aid the response efforts and ease the economic impact of COVID-19.

Coronavirus (COVID-19) Update: FDA takes further steps to help mitigate supply interruptions of food and medical products
Sat, 28 Mar 2020 17:26:53 EDT

  FDA takes further steps to help mitigate supply interruptions of food and medical products

Coronavirus (COVID-19) Update: Daily Roundup March 27, 2020
Fri, 27 Mar 2020 20:28:54 EDT

  Coronavirus (COVID-19) Update: Daily Roundup

Coronavirus (COVID-19) Update: FDA takes action to help increase U.S. supply of ventilators and respirators for protection of health care workers, patients
Fri, 27 Mar 2020 11:13:11 EDT

  FDA took action to help increase the supply of ventilators and respirators due to shortages during COVID-19

Coronavirus (COVID-19) Update: Daily Roundup March 26, 2020
Thu, 26 Mar 2020 21:49:01 EDT

  Coronavirus (COVID-19) Update: Daily Roundup

FDA Continues to Support Transparency and Collaboration in Drug Approval Process as the Clinical Data Summary Pilot Concludes
Thu, 26 Mar 2020 11:26:16 EDT

  After receiving useful feedback as part of the Clinical Data Summary Pilot Program, FDA has decided to conclude the pilot. FDA continues to invest in our work with international partners.

Coronavirus (COVID-19) Update: Daily Roundup, March 25, 2020
Wed, 25 Mar 2020 21:25:39 EDT

  Coronavirus (COVID-19) Update: Daily Roundup

Coronavirus (COVID-19) Update: Daily Roundup, March 24, 2020
Tue, 24 Mar 2020 19:29:54 EDT

  Coronavirus (COVID-19) Update: Daily Roundup

Coronavirus (COVID-19) Update: FDA takes action to increase U.S. supplies through instructions for PPE and device manufacturers
Tue, 24 Mar 2020 13:18:01 EDT

  Coronavirus (COVID-19) Update: FDA takes action to increase U.S. supplies through instructions for PPE and device manufacturers

Food and Drugs Administration--Recalls/Safety Alerts

Dr. Reddy's Laboratories Issues Voluntary Nationwide Recall of Phytonadione Injectable Emulsion USP, 10 mg/mL Single-Dose Ampules Due To Ampules Breaking And Shattering Upon Opening
Thu, 26 Mar 2020 16:28:00 EDT

  Dr. Reddy’s Laboratories Ltd. (along with its subsidiaries together referred to as “Dr. Reddy’s”) announced today that it is voluntarily recalling four lots (ACB902, ACB903, ACB904, ACB905) of Phytonadione Injectable Emulsion USP, 10 mg/mL, Single-Dose Ampules to the hospital level. The product is b

Allergy Alert Issued By Winter Gardens Quality Foods, Inc. for Undeclared Milk in Vodka Sauce
Thu, 26 Mar 2020 00:00:00 EDT

  Winter Gardens Quality Foods, Inc., is voluntary recalling one of its products: Whole Foods Market Vodka Sauce carrying the lot code 20057, because of an undeclared allergen (Milk).

Tiffany Food Corp. Issues Alert on Undeclared Sulfites in Huangfushanzen Dried Mushrooms
Tue, 24 Mar 2020 10:44:00 EDT

  Tiffany Food Corp. of Brooklyn, NY is recalling Huangfushanzen Huang Mountain Tea Mushroom (黄府山珍茶花菇) Dried Mushrooms with UPC 6 943153 804047 and no other coding, because it may contain undeclared sulfites

Guan’s Mushroom Co Recalls Enoki Because of Possible Health Risk
Mon, 23 Mar 2020 00:00:00 EDT

  Guan’s Mushroom Co of Commerce, CA is recalling all cases of its 200g/7.05 ounce packages of Enoki Mushroom (Product of Korea) because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail

IcelandicPlus LLC Voluntarily Recalls Whole Capelin Fish Pet Treats Because Product Exceeds FDA Size Restrictions
Thu, 19 Mar 2020 12:00:00 EDT

  Out of an abundance of caution IcelandicPlus LLC of Ft. Washington, PA, is recalling its Capelin Pet Treats because some of the fish have exceeded the FDA compliance guideline for fish larger than 5 inches. The FDA has determined that salt-cured, dried, or fermented un-eviscerated fish larger than 5

Lindt & Sprüngli (USA) Inc. Issues Voluntary Recall on Undeclared Milk and Soy in One Lot of Lindt Excellence 85% Cocoa Chocolate Bars
Thu, 19 Mar 2020 09:36:00 EDT

  Lindt & Sprüngli (USA) Inc. of Stratham, New Hampshire, is issuing a voluntary recall of one lot of its Lindt Excellence 85% Cocoa chocolate bars due to the bars being wrapped in the wrong packaging. The bars are labeled as Excellence 85% Cocoa, but contain Lindt Excellence Dark Caramel Sea Salt bar

Mountain Rose Herbs Recalls Organic Kudzu Root Herbal Supplement Due to Possible Health Risk
Wed, 18 Mar 2020 21:04:00 EDT

  Mountain Rose Herbs (MRH) of Eugene, Oregon is recalling all sizes of its Organic Kudzu Root Herbal Supplement from Lot #24247-X and #24247 because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail

Chicago Indoor Garden Voluntarily Recalls Clover Sprouts and Products Containing Clover Sprouts Due To Possible Health Risk
Mon, 16 Mar 2020 19:49:00 EDT

  It has been brought to our attention by the FDA that products containing Red Clover sprouts purchased with the "Best By" dates between 12/1/19 through 3/12/20 may have been contaminated with E. coli0103. At this time no illnesses have been reported

Natural Remedy Store Issues Voluntary Worldwide - Recall of Active Male Due to Presence of Undeclared Tadalafil
Mon, 16 Mar 2020 19:22:00 EDT

  Natural Remedy Store is voluntarily recalling all lots of Active Male, 500mg capsules to the consumer level. FDA analysis has found the product to be tainted with undeclared tadalafil

Raw Seafoods, Inc. Issues Allergy Alert on Undeclared Wheat in Wegmans Brand Oven Safe Salmon Teriyaki and Oven Safe Ginger Salmon
Mon, 16 Mar 2020 00:00:00 EDT

  This recall is due to an undeclared wheat allergen in Wegmans branded Ginger Salmon Oven Safe Meal and Salmon Teriyaki Oven Safe Meal, which was manufactured by Raw Seafoods, Inc. for Wegmans. No illnesses or allergic reactions have been reported at this time.

Winco Foods, LLC Recalls Frozen Blackberries and Frozen Berry Medley Because of Possible Health Risk
Fri, 13 Mar 2020 00:00:00 EDT

  March 13th, 2020, WinCo Foods, LLC. of Boise, ID is recalling frozen Blackberries in a 16 oz. bag and frozen Berry Medley in 16 oz. and 32 oz. bags, manufactured by Rader Farms of Lynden, WA, because both products have the potential to be contaminated with Norovirus. Norovirus is a highly contagiou

Cooked Butterfly Tail-On Whiteleg Shrimp (Sushi Ebi), Lot #2019.10.02
Fri, 13 Mar 2020 00:00:00 EDT

  AFC Distribution Corp. (“AFC”) of Rancho Dominguez, California is voluntary recalling Cooked Butterfly Tail-On Whiteleg Shrimp (Sushi Ebi), Lot #2019.10.02, utilized in various prepared menu offerings with sell-by dates ranging from 02/19/2020 to 03/13/2020, because this ingredient may have a potent

Pero Family Farms Food Co. Issues Alert on Undeclared Egg and Milk Allergens in Zucchini Trays
Wed, 11 Mar 2020 00:00:00 EDT

  Pero Family Farms Food Company, LLC has initiated a voluntary product recall of its 11oz “Zucchini Spiral Pesto Side Dish Kit” with run number code 1196272F; Use By date of 03/20/2020 due to a product mislabeling which did not declare the allergens of egg and milk.

BD Provides Update on Feb. 4, 2020 Voluntary Recall of the BD Alaris™ System PC Units and Modules
Mon, 09 Mar 2020 00:00:00 EDT

  BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today provided an update on a previously announced voluntary recall of the BD Alaris™ System regarding software for the PC Unit and certain modules. BD has notified customers affected by this recall, and the

Sun Hong Foods, Inc. Recalls Enoki Mushroom Because of Possible Health Risk
Mon, 09 Mar 2020 00:00:00 EDT

  Sun Hong Foods, Inc 1105 W Olympic Blvd, Montebello, CA 90640 is recalling All Cases Enoki Mushroom (Product of Korea) Net Wt 7.05/200g because it has the potential to be contaminated with Listeria monocytogenes

Meijer Recalls Select Mixed Nuts due to Undeclared Brazil Nuts in Product
Mon, 09 Mar 2020 00:00:00 EDT

  Meijer is initiating a voluntary recall of 13,284 packages of mixed nuts due to the potential risk of an undeclared tree-nut allergen (Brazil nuts) sold at all Meijer stores, and is being issued to its customers in cooperation with the U.S. Food & Drug Administration.

Dole Fresh Vegetables, Inc. Announces Voluntary Limited Recall of H-E-B-branded Tuscan Herb Salad Kit Due to Undeclared Allergens
Fri, 06 Mar 2020 00:00:00 EST

  This recall is due to possible undeclared allergens (peanut, wheat, soy and tree nuts) in H-E-B-branded Tuscan Herb Salad Kit, which was manufactured by Dole for H-E-B. The incorrect masterpack (kit with dressing and other toppings) was unintentionally used during the production of the salad.

Stonewall Kitchen Voluntarily Recalls a Limited Amount of Mislabeled Ghost Pepper Salsa which contains Ghost Pepper Queso
Thu, 05 Mar 2020 00:00:00 EST

  Stonewall Kitchen of York, Maine is voluntarily recalling 4,812 jars of its Ghost Pepper Queso with an Enjoy By date of 23MAY2021, as a small number of those were mislabeled as Ghost Pepper Salsa. Ghost Pepper Queso includes two allergens, milk and soy, that are not included in Ghost Pepper Salsa, a

Vita Food Products Issues Voluntary Recall of Mislabeled Vita Wild Herring Wine Sauce Containing Undeclared Milk
Wed, 04 Mar 2020 00:00:00 EST

  Vita Food Products, Inc. of Chicago, Illinois is notifying the public that it is recalling up to 8,376 individual plastic jars of 32 ounce Vita Wild Herring in Wine Sauce that are potentially mislabeled because they may contain sour cream and, therefore, may contain undeclared milk.

Hikma Pharmaceuticals USA Inc. Extends Voluntary Nationwide Recall of Ketorolac Tromethamine Injection, USP 30mg/mL, 1mL Fill/2mL Vials Due to the Potential Presence of Small Particulates
Wed, 04 Mar 2020 00:00:00 EST

  Hikma Pharmaceuticals PLC (Hikma, Group), today announces that its subsidiary Hikma Pharmaceuticals USA Inc. (formerly known as West-Ward Pharmaceuticals Corp.; “Hikma”) is voluntarily extending its previously-announced recall of certain lots (listed below) of Ketorolac Tromethamine Injection USP 30

What's New: Drugs RSS Feed

Emergency Use Authorization
Sat, 04 Apr 2020 14:43:18 EDT

  The Emergency Use Authorization (EUA) authority allows FDA to help strengthen the nation’s public health protections against CBRN threats by facilitating the availability and use of MCMs needed during public health emergencies

Antimicrobial Resistance Information from FDA
Fri, 03 Apr 2020 17:24:49 EDT

  Antimicrobial resistance (AMR)—the ability of a microorganism (bacteria, virus, fungi, parasite) to resist the effects of a drug—is a serious, complex and costly public health problem. Learn what FDA is doing to address AMR.

Newly Added Guidance Documents
Fri, 03 Apr 2020 17:04:33 EDT

  Guidance documents represent the FDA's current thinking on a particular subject. New guidance documents are listed here for three months.

What's New Related to Drugs
Fri, 03 Apr 2020 16:56:53 EDT

  Want to know what's new on drugs from FDA? This page provides quick links to the latest on a variety of topics including: drug approvals, safety warnings, drug shortages, etc.

Fees for Human Drug Compounding Outsourcing Facilities Under Sections 503B and 744K of the FD&C Act
Fri, 03 Apr 2020 16:52:11 EDT

  Fees for Human Drug Compounding Outsourcing Facilities Under Sections 503B and 744K of the FD&C Act

FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic
Fri, 03 Apr 2020 16:21:32 EDT

  FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic | Guidance for Industry, Investigators, and Institutional Review Boards

FDA Voices: Perspectives From FDA Leadership and Experts
Fri, 03 Apr 2020 11:40:42 EDT

  Insights into the agency's work in the areas of medical products, food, tobacco, policy, consumer safety and enforcement.

Anesthetic and Analgesic Drug Products Advisory Committee Roster
Fri, 03 Apr 2020 11:19:47 EDT

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

January 16, 2020: Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee Meeting Announcement - 01/16/2020 - 01/16/2020
Fri, 03 Apr 2020 09:24:38 EDT

  January 16, 2020: Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee Meeting Announcement

Search List of Extended Use Dates to Assist with Drug Shortages
Fri, 03 Apr 2020 06:11:51 EDT

  This is to update and consolidate the extended use date information posted previously to assist with drug shortage (6/15/17 to present).

Development Considerations of Antifungal Drugs to Address Unmet Medical Need - 08/04/2020 - 08/04/2020
Thu, 02 Apr 2020 23:22:35 EDT

  Clinical Trial Design Considerations for the Development of Antifungal Drugs

Developing Antifungal Drugs for the Treatment of Coccidiodomycosis (Valley Fever) Infection - 08/05/2020 - 08/05/2020
Thu, 02 Apr 2020 23:18:49 EDT

  Developing Antifungal Drugs for the Treatment of Coccidiodomycosis (Valley Fever) Infection

FDA Commissioned Corps Officers on the Front Line of COVID-19 Response
Thu, 02 Apr 2020 17:01:50 EDT

  Almost 400 FDA Commissioned Corps officers deployed to aid in response to the coronavirus public health emergency

Health Canada and FDA Joint Public Consultation on International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - 04/03/2020 - 04/03/2020
Thu, 02 Apr 2020 16:24:05 EDT

  The Food and Drug Administration (FDA) is announcing a regional public meeting entitled ‘‘Health Canada and United States Food and Drug Administration Joint Public Consultation on International Council for Harmonisation of Technical Requirements for Human Use (ICH)’’.

Frequently requested or proactively posted compliance records
Thu, 02 Apr 2020 15:34:12 EDT

  Frequently requested inspection records of foreign pharmaceutical manufacturing facilities

Compounding Quality Center of Excellence: In-Person Training Programs
Thu, 02 Apr 2020 12:06:56 EDT

  The Compounding Quality Center of Excellence’s free in-person training programs target outsourcing facility staff and offer continuing education credits. The training will open for state regulators and pharmacy compounders if space is available.

Regulatory Education for Industry (REdI): Generic Drugs Forum April 15 & 16, 2020 - 04/15/2020 - 04/16/2020
Thu, 02 Apr 2020 10:58:16 EDT

  This event offers practical advice, case studies, and a look at generic drug topics. FDA will also discuss science unique to generic drug applications.

Recently Issued Guidance Documents
Thu, 02 Apr 2020 10:34:59 EDT

  This page lists Recently Issued CBER and Cross-Center Guidance Documents.

Reorganization of the Office of New Drugs with Corresponding Changes to the Office of Translational Sciences and the Office of Pharmaceutical Quality
Thu, 02 Apr 2020 10:06:24 EDT

  The New Drugs Regulatory Program Modernization’s reorganization of the Office of New Drugs (OND), with corresponding changes to the Office of Translational Sciences (OTS) and the Office of Pharmaceutical Quality (OPQ)

Gaia's Whole Healing Essentials, LLC - 605893 - 04/01/2020
Thu, 02 Apr 2020 10:00:07 EDT

  Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19)

Whats New Vaccines Blood Biologics RSS Feed

Emergency Use Authorization
Sat, 04 Apr 2020 14:43:18 EDT

  The Emergency Use Authorization (EUA) authority allows FDA to help strengthen the nation’s public health protections against CBRN threats by facilitating the availability and use of MCMs needed during public health emergencies

What’s New for Biologics
Fri, 03 Apr 2020 20:59:57 EDT

  Latest news from the Center for Biologics Evaluation and Research

Antimicrobial Resistance Information from FDA
Fri, 03 Apr 2020 17:24:49 EDT

  Antimicrobial resistance (AMR)—the ability of a microorganism (bacteria, virus, fungi, parasite) to resist the effects of a drug—is a serious, complex and costly public health problem. Learn what FDA is doing to address AMR.

FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic
Fri, 03 Apr 2020 16:21:32 EDT

  FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic | Guidance for Industry, Investigators, and Institutional Review Boards

Facilitating End-to-End Development of Individualized Therapeutics - 03/03/2020 - 03/03/2020
Fri, 03 Apr 2020 15:23:39 EDT

  The purpose of the CBER Individualized Therapeutics public workshop is to foster development of individualized therapeutic products for the treatment of one individual or a very small number of patients, based on engineering a product aimed at the specific molecular mechanism underlying a patient’s (or small group of patients’) illness

FDA Voices: Perspectives From FDA Leadership and Experts
Fri, 03 Apr 2020 11:40:42 EDT

  Insights into the agency's work in the areas of medical products, food, tobacco, policy, consumer safety and enforcement.

Regenerative Medicine Advanced Therapy Designation
Fri, 03 Apr 2020 11:01:36 EDT

  Eligibility requirements for a regenerative medicine advanced therapy (RMAT) designation. Information on when and where to submit the request is also provided.

DG Gel 8 ABO/Rh (2D)
Fri, 03 Apr 2020 10:38:57 EDT

  The DG Gel 8 ABO/Rh (2D) card is for the determination of ABO forward and reverse group, and RhD antigen on the surface of red blood cells of human blood samples. For use with the DG Gel System. For in vitro diagnostic use.

BIMO/Team Biologics/Internet Surveillance/Other
Fri, 03 Apr 2020 09:48:19 EDT

  This is the main page for the CBER BIMO/Team Biologics/Internet Surveillance/Other.

Section 8400: Marketing Applications
Fri, 03 Apr 2020 08:24:32 EDT

  This is the SOPP Section 8400: Marketing Applications main page.

FDA Commissioned Corps Officers on the Front Line of COVID-19 Response
Thu, 02 Apr 2020 17:01:50 EDT

  Almost 400 FDA Commissioned Corps officers deployed to aid in response to the coronavirus public health emergency

CBER-Regulated Products: Shortages and Discontinuations
Thu, 02 Apr 2020 13:22:29 EDT

  A CBER-regulated product shortage occurs when a CBER-regulated product is not commercially available in sufficient quantity to meet the demand.

Blood Guidances
Thu, 02 Apr 2020 11:19:51 EDT

  This page contains a listing of Blood Guidances guidances.

Alternative Procedures for Blood and Blood Components During the COVID-19 Public Health Emergency
Thu, 02 Apr 2020 10:56:09 EDT

  This is the Guidance for Industry, Alternative Procedures for Blood and Blood Components During the COVID-19 Public Health Emergency

Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Components
Thu, 02 Apr 2020 10:49:28 EDT

  This guidance finalizes the draft guidance of the same title dated January 2020, and supersedes the document entitled “Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products.

Revised Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria
Thu, 02 Apr 2020 10:47:37 EDT

  This revised guidance document provides you, blood establishments that collect blood and blood components, with FDA’s recommendations to reduce the risk of transfusion-transmitted malaria (TTM).

Recently Issued Guidance Documents
Thu, 02 Apr 2020 10:34:59 EDT

  This page lists Recently Issued CBER and Cross-Center Guidance Documents.

Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products
Thu, 02 Apr 2020 10:19:44 EDT

  This revised guidance document provides you, blood establishments that collect blood or blood components, including Source Plasma, with FDA’s revised donor deferral recommendations for individuals with increased risk for transmitting human immunodeficiency virus (HIV) infection.

Expiration Date Extension for Anavip [Crotalidae Immune F(ab’)2 (Equine)]: Lot B-8G-33 through July 31, 2021; Lot B-9B-33 through February 28, 2022; and Lot B-9E-35 through June 30, 2022
Thu, 02 Apr 2020 10:03:31 EDT

  Anavip product was manufactured for Instituto Bioclon by Laboratorios Silanes. After evaluation of stability data, FDA has extended the expiration date on all lots of Anavip® from 24 months to 36 months providing an additional year of shelf life on all current and future lots of Anavip.

SEVENFACT
Wed, 01 Apr 2020 16:21:17 EDT

  Treatment and control of bleeding episodes occurring in adults and adolescents (12 years of age and older) with hemophilia A or B with inhibitors







 
 

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