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: January 22, 2021
Fri, 22 Jan 2021 15:42:22 EST

  Coronavirus (COVID-19) Update

FDA Approves First Extended-Release, Injectable Drug Regimen for Adults Living with HIV
Thu, 21 Jan 2021 16:23:01 EST

  Today, the FDA approved Cabenuva as the first injectable, complete regimen for HIV-infected adults that is administered once a month.

Coronavirus (COVID-19) Update: January 19, 2021
Tue, 19 Jan 2021 16:56:59 EST

  Coronavirus (COVID-19) Update

FDA Marks Historic Public Health Milestone with Finalization of Two Key Rules for Companies Seeking to Market New Tobacco Products
Tue, 19 Jan 2021 16:49:09 EST

  FDA finalized two foundational rules for the premarket review of new tobacco products. These final rules provide additional information on the minimum requirements for the content, format and review of premarket tobacco product applications (PMTAs) and substantial equivalence (SE) reports.

Coronavirus (COVID-19) Update: January 15, 2021
Fri, 15 Jan 2021 17:36:05 EST

  Coronavirus (COVID-19) Update

Federal judge enters consent decree against Washington state juice processor
Fri, 15 Jan 2021 14:18:11 EST

  The U.S. District Court for the Eastern District of Washington entered a consent decree between the FDA and Valley Processing, Inc., to stop distributing adulterated juice products until the company complies with the Federal Food, Drug, and Cosmetic Act (FD&C Act)

FDA Warns Firms to Remove Unauthorized E-liquid Products from Market in First Letters Issued to Manufacturers that Did Not Submit Premarket Applications by Deadline
Fri, 15 Jan 2021 13:58:33 EST

  FDA issued warning letters to firms manufacturing and operating websites selling flavored e-liquids advising that selling these products lacking premarket authorization is illegal, and therefore cannot be sold or distributed in the U.S.

FDA Grants First Conditional Approval Under Expanded Authority to Control Seizures in Dogs with Idiopathic Epilepsy
Thu, 14 Jan 2021 13:57:37 EST

  The U.S. Food and Drug Administration granted the first conditional approval under its expanded authority to KBroVet-CA1 (potassium bromide chewable tablets) to treat dogs with seizures associated with idiopathic epilepsy.

CBP, FDA Seize Counterfeit, Unauthorized E-Cigarettes
Wed, 13 Jan 2021 15:18:38 EST

  U.S. Customs and Border Protection officers at the Dallas Fort Worth International Airport working in conjunction with agents from the U.S. Food and Drug Administration announced today that they have seized over 33,681 units of e-cigarettes with a Manufacturer’s Suggested Retail Price of $719,453.

FDA Releases Artificial Intelligence/Machine Learning Action Plan
Tue, 12 Jan 2021 10:35:40 EST

  FDA has released the Artificial Intelligence/Machine Learning- Based Software as a Medical Device Action Plan which outlines FDA’s next steps towards advancing practical oversight for these issues.

FDA Conditionally Approves First Oral Tablet to Treat Lymphoma in Dogs
Mon, 11 Jan 2021 13:44:40 EST

  The U.S. Food and Drug Administration has conditionally approved Laverdia-CA1 (verdinexor), the first oral tablet for treatment of canine lymphoma.

Coronavirus (COVID-19) Update: January 8, 2021
Fri, 08 Jan 2021 15:28:21 EST

  Coronavirus (COVID-19) Update: January 8, 2021

FDA Issues Alert Regarding SARS-CoV-2 Viral Mutation to Health Care Providers and Clinical Laboratory Staff
Fri, 08 Jan 2021 11:47:43 EST

  FDA is alerting clinical laboratory staff and health care providers that it is monitoring the impact of viral mutations, including the variant from the United Kingdom, the B.1.1.7 variant, on authorized SARS-CoV-2 molecular tests, and that false negative results can occur with any molecular test.

Coronavirus (COVID-19) Update: January 5, 2021
Tue, 05 Jan 2021 14:56:56 EST

  Coronavirus (COVID-19) Update

FDA Statement on Following the Authorized Dosing Schedules for COVID-19 Vaccines
Mon, 04 Jan 2021 19:30:50 EST

  FDA Statement on Following the Authorized Dosing Schedules for COVID-19 Vaccines

FDA Takes Steps to Provide Clarity on Developing New Drug Products in the Age of Individualized Medicine
Mon, 04 Jan 2021 10:02:21 EST

  FDA releases a new draft guidance on investigational new drug (IND) submissions for individualized ASO drug products.

Coronavirus (COVID-19) Update: December 30, 2020
Wed, 30 Dec 2020 17:04:44 EST

  Coronavirus (COVID-19) Update

Coronavirus (COVID-19) Update: December 28, 2020
Mon, 28 Dec 2020 17:43:52 EST

  Coronavirus (COVID-19) Update

FDA Approves First Generic of Drug Used to Treat Severe Hypoglycemia
Mon, 28 Dec 2020 17:35:09 EST

  The FDA has approved the first generic of glucagon for injection for the treatment of severe hypoglycemia (very low blood sugar), which may occur in patients with diabetes mellitus.

FDA Takes Further Steps to Confront Opioid Crisis Through Risk Evaluation and Mitigation Strategy Programs
Wed, 23 Dec 2020 17:46:47 EST

  The FDA took further steps to strengthen the transmucosal immediate-release fentanyl (TIRF) REMS program with approval of modifications that which will ensure that the benefits of these drugs continue to outweigh the risks.

Food and Drugs Administration--Recalls/Safety Alerts

Nostrum Laboratories, Inc. Expands Voluntary Nationwide Recall of Metformin HCl Extended Release Tablets, USP 750 mg, Due to N-Nitrosodimethylamine (NDMA) Content Above the Acceptable Daily Intake (ADI) Limit
Mon, 25 Jan 2021 16:33:00 EST

  Nostrum Laboratories, Inc. is voluntarily recalling one lot of Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets) to the consumer level. The Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets) have been found to con

House-Autry Mills Announces Voluntary Recall of House-Autry Tartar Sauce Due to Spoilage
Fri, 22 Jan 2021 00:00:00 EST

  House-Autry Mills, Inc. is voluntarily recalling 9 oz. House-Autry Tartar Sauce (60013) with the following Best By dates: BB 08182021, BB 08232021, BB 09162021, BB 09172021, BB 09182021 and BB 09212021 as a precaution, due to the verification of spoilage associated with the product

Bickel’s Snack Foods, Inc. Issues Allergy Alert on Specific Lot of Butter Flavored Popcorn
Fri, 22 Jan 2021 00:00:00 EST

  Bickel’s Snack Foods, Inc. is voluntarily recalling one specific lot of 8 oz. Butter Flavored Popcorn bearing UPC code 70175 06021 due to the undeclared presence of milk. Consumers with an allergy or severe sensitivity to milk could experience a serious or life-threatening reaction if they consume

Frito-Lay Issues Voluntary Allergy Alert on Undeclared Milk in Small Number of Ruffles Original Potato Chips
Thu, 21 Jan 2021 16:56:00 EST

  Frito-Lay today issued a voluntary recall of a small number of 13 1/2 oz. “Party Size” bags of Ruffles Original Potato Chips because they may contain undeclared milk ingredients. People who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction

Door County Coffee & Tea Co Issues Allergy Alert on Undeclared Milk and Soy in French Vanilla Flavored Cappuccino Single Serve Cups
Thu, 21 Jan 2021 00:00:00 EST

  Door County Coffee & Tea Co of Sturgeon Bay, WI, is recalling its 5.1 ounce packages of French Vanilla Flavored Cappuccino Single Serve Cups because they may contain undeclared Milk and Soy. People who have allergies to Milk and Soy run the risk of serious or life-threatening allergic reaction if th

Lancaster Foods Recalls All Conventional Butternut Squash Items That Were Processed between the Dates of 12/22/20 and 01/08/21 Due to Possible Health Risk
Tue, 19 Jan 2021 00:00:00 EST

  Lancaster Foods LLC has initiated a voluntary product recall of its processed butternut squash items because they have the potential to be contaminated with Listeria Monocytogenes

Hiland Dairy Announces Recall of Hiland Dairy Half-Pint 1% Low Fat Chocolate Milk Cartons
Sun, 17 Jan 2021 22:32:00 EST

  Hiland Dairy is announcing a recall of the one-half pint (236 mL) 1% low fat chocolate milk that was produced at its Norman, Oklahoma facility only. Some of the products may contain food-grade sanitizers, which could cause illness if consumed

Potential Foreign Object Recall Lake Champlain Chocolates Issues Voluntary Recall on Selected Milk Chocolate Products
Sat, 16 Jan 2021 16:41:00 EST

  Lake Champlain Chocolates (LCC) is issuing a public alert and a voluntary recall on select LCC milk chocolate products from a determined best-by date range for potential foreign objects. LCC is issuing this recall after a consumer reported finding brittle plastic pieces in a finished product. After

Pero Family Farms Food Co. Issues Voluntary Recall Due to Possible Health Risk
Fri, 15 Jan 2021 00:00:00 EST

  Pero Family Farms Food Company, LLC has initiated a voluntary product recall of its Butternut Squash Trays 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 or elderly people and ot

Publix Steam In Bag Product Recall
Thu, 14 Jan 2021 00:00:00 EST

  Publix Super Markets, Inc. has initiated a voluntary recall on select Publix Steam In Bag products prepared in-store containing a specific butternut squash ingredient. This recall is the result of notification of a recall for possible Listeria monocytogenes contamination from Pero Family Farms Compa

Boston Scientific Announces LOTUS Edge™ Aortic Valve System Voluntary Recall and Product Discontinuation
Mon, 11 Jan 2021 00:00:00 EST

  Boston Scientific Corporation (NYSE: BSX) has announced it has initiated a global, voluntary recall of all unused inventory of the LOTUS Edge™ Aortic Valve System due to complexities associated with the product delivery system. The voluntary recall is related solely to the delivery system, as the va

Lavva Voluntarily Recalls a Single Lot of Blueberry Plant-Based Yogurt
Mon, 11 Jan 2021 00:00:00 EST

  Out of an abundance of caution, EVR Foods, INC, parent company to Lavva, is issuing a voluntary recall on its 5.3 ounce Blueberry Plant-Based Yogurt with expiration date 2/21/21.

Midwestern Pet Foods Voluntarily Expands Recall of Pet Food for Aflatoxin Health Risk
Mon, 11 Jan 2021 00:00:00 EST

  Midwestern Pet Foods, Inc., of Evansville, IN is expanding its December 30, 2020 voluntary recall ofcertain dog and cat food products produced in our Chickasha Operations Facility to include all dog and cat pet food products made with corn products because those products may contain aflatoxin level

Fresenius Kabi Issues Voluntary Nationwide Recall of Ketorolac Tromethamine Injection, USP Due to the Presence of Particulate Matter
Fri, 08 Jan 2021 00:00:00 EST

  Fresenius Kabi USA is voluntarily recalling a single lot of Ketorolac Tromethamine Injection, USP, 30 mg/mL, 1 mL fill in a 2 mL amber vial to the user level due to the presence of particulate matter. Particulate matter was found in reserve sample vials. No adverse event reports have been received

Weis Markets Issues Recall for Possible Foreign Matter Contamination in Weis Ice Cream Products
Fri, 08 Jan 2021 00:00:00 EST

  Weis Markets today said it has issued a recall for:
• 10,869 containers of Weis Quality Cookies and Cream Ice Cream (48 oz.), and
• 502 bulk containers of Klein’s Vanilla Dairy Ice Cream (3 gallon)
because the products may be contaminated with extraneous material, specifically metal filling equipme

Dole Fresh Vegetables Announces Limited Voluntary Recall of Dole™ Sesame Asian Chopped Salad Kit Due to Undeclared Allergens
Tue, 05 Jan 2021 16:24:00 EST

  This voluntary recall is due to possible undeclared allergens (egg) in Dole™ Sesame Asian Chopped Salad Kit. The dressing and topping kit (masterpack) designed for a different Dole product was unintentionally used during a portion of the production of the salad. Dole Fresh Vegetables, Inc. is coordi

Nostrum Laboratories, Inc. Expands Voluntary Nationwide Recall of Metformin HCl Extended Release Tablets, USP 750 mg, Due to N-Nitrosodimethylamine (NDMA) Content Above the Acceptable Daily Intake (ADI) Limit
Mon, 04 Jan 2021 00:00:00 EST

  Nostrum Laboratories, Inc. is voluntarily recalling one lot of Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets) to the consumer level. The Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets) have been found to con

Essaar Inc. Issues Voluntary Nationwide Recall of Rubbing Alcohol Contaminated with Methanol
Mon, 04 Jan 2021 00:00:00 EST

  Essaar Inc. is voluntarily recalling lot 200528303 of Soho Fresh 70% Rubbing Alcohol in 33.81 oz. clear plastic bottles to the consumer level. FDA analysis of the product revealed it is contaminated with methanol. Substantial methanol exposure can result in nausea, vomiting, headache, blurred visio

Divvies, LLC Issues Allergy Alert on Undeclared Milk and Eggs in Vanilla Cupcakes
Thu, 31 Dec 2020 12:08:00 EST

  Divvies of Trumbull, CT is recalling Vanilla Cupcakes with Vanilla Frosting and Vanilla Cupcakes with Chocolate Frosting because they may contain undeclared milk and eggs.

Precision Dose, Inc. Issues Voluntary Nationwide Recall of Paroex Chlorhexidine Gluconate Oral Rinse USP, 0.12%, 15mL Due to Microbial Contamination
Thu, 31 Dec 2020 00:00:00 EST

  Precision Dose, Inc. is voluntarily recalling all lots of Chlorhexidine Gluconate Oral Rinse USP, 0.12%, 15mL Unit Dose Cups bearing an expiration date from 1/31/2021 – 02/28/2022 (see specific lots below) to the consumer level

What's New: Drugs RSS Feed

FDA-ASCO Virtual Workshop Defining a Research Agenda to Address Barriers and Solutions to Oral Anticancer Agent Adherence - 02/02/2021 - 02/03/2021
Mon, 25 Jan 2021 20:29:19 EST

  FDA-ASCO Virtual Workshop

Nostrum Laboratories, Inc. Expands Voluntary Nationwide Recall of Metformin HCl Extended Release Tablets, USP 750 mg, Due to N-Nitrosodimethylamine (NDMA) Content Above the Acceptable Daily Intake (ADI) Limit
Mon, 25 Jan 2021 18:28:33 EST

  Nostrum Laboratories, Inc. is voluntarily recalling one lot of Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets) to the consumer level. The Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets) have been found to con

What's New Related to Drugs
Mon, 25 Jan 2021 18:06:18 EST

  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.

Nostrum Laboratories, Inc. Expands Voluntary Nationwide Recall of Metformin HCl Extended Release Tablets, USP 750 mg, Due to N-Nitrosodimethylamine (NDMA) Content Above the Acceptable Daily Intake (ADI) Limit
Mon, 25 Jan 2021 17:47:21 EST

  Nostrum Laboratories, Inc. is voluntarily recalling one lot of Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets) to the consumer level. The Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets) have been found to con

Nostrum Laboratories, Inc. Issues Voluntary Nationwide Recall of Metformin HCl Extended Release Tablets, USP 500 mg, Due to N-Nitrosodimethylamine (NDMA) Content Above the Acceptable Daily Intake (ADI) Limit
Mon, 25 Jan 2021 17:42:19 EST

  Nostrum Laboratories, Inc. is voluntarily recalling 2 (two) lots of Metformin HCl Extended Release Tablets, USP 500 mg to the consumer level. The Metformin HCl Extended Release Tablets, USP 500 mg have been found to contain levels of nitrosamine impurities above the ADI limit of 96 ng/day as publish

Guidances (Drugs)
Mon, 25 Jan 2021 17:14:44 EST

  Newly added and withdrawn guidances can be found at Guidances (Drugs). FDA guidance documents discuss the production, labeling, manufacturing of regulated products and denote FDA's current thinking and policy interpretation.

Compounding Activities | COVID-19
Mon, 25 Jan 2021 16:20:48 EST

  Providing guidance on compounded drugs

GDUFA Paid Facilities List
Mon, 25 Jan 2021 15:39:07 EST

  This list contains GDUFA facility payments received by the Agency. Data are extract from the User Fee System and GDUFA Facility User Fee Coversheets. The following table explains the terms used in the list:

Phonetic and Orthographic Computer Analysis (POCA) Program
Mon, 25 Jan 2021 15:29:06 EST

  Use CDER’s Phonetic and Orthographic Computer Analysis (POCA) to help identify drug and biologic names that are phonetically and/or orthographically similar to one another. In conducting proprietary name reviews, the Division of Medication Error Prevention and Analysis (DMEPA) evaluates the orthographic and phonetic similarity of a proposed proprietary name to other proprietary or established names using the POCA software program. POCA uses algorithms to assess the similarity of names when spoken or written and assigns a percent similarity score to a given name pair.

UPDATED TIME, AGENDA, AND MEETING MATERIALS: October 9, 2020: Joint Meeting of the Psychopharmacologic Drugs Advisory Committee (PDAC) and the Drug Safety and Risk Management Advisory Committee (DSaRM) Meeting Announcement - 10/09/2020 - 10/09/2020
Mon, 25 Jan 2021 15:25:31 EST

  October 9, 2020: Joint Meeting of the Psychopharmacologic Drugs Advisory Committee (PDAC) and the Drug Safety and Risk Management Advisory Committee (DSaRM) Meeting Announcement

UPDATED TIME AND MEETING MATERIALS INFORMATION: October 8, 2020 Joint Meeting of the Psychopharmacologic Drugs Advisory Committee (PDAC) and the Drug Safety and Risk Management Advisory Committee (DSaRM) Meeting Announcement - 10/08/2020 - 10/08/2020
Mon, 25 Jan 2021 14:59:21 EST

  October 8, 2020 Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting Announcement

Reviews of Pediatric Studies Conducted under BPCA and PREA from 2012 – present
Mon, 25 Jan 2021 14:32:40 EST

  The following are the medical, statistical, and clinical pharmacology reviews of pediatric studies conducted in response to a Written Request issued under the BPCA and pediatric assessments conducted under PREA.

Comunicado de la FDA sobre la seguridad de los medicamentos: FDA requiere cambios en la etiqueta para advertir acerca del riesgo de daño neurológico potencialmente permanente por el uso de antibióticos con fluoroquinolona inyectados o de uso oral
Mon, 25 Jan 2021 13:59:22 EST

  El 15 de agosto, 2013, La Administración de Alimentos y Medicamentos de Estados Unidos (FDA por sus siglas en inglés) requirió que se actualicen las etiquetas del medicamento y las Guías del Medicamento para todos los antibióticos con fluoroquinolona para que describan mejor el serio efecto secundario de neuropatía periférica.

Comunicado de la FDA sobre la seguridad de los medicamentos: FDA requiere cambios en la etiqueta para advertir sobre problemas neurológicos graves pero poco frecuentes, tras una inyección epidural de corticosteroides para aliviar el dolor
Mon, 25 Jan 2021 13:47:24 EST

  [4-23-2014] La Administración de Alimentos y Medicamentos de Estados Unidos (FDA por su sigla en inglés) advierte que, en casos poco frecuentes, la inyección de corticosteroides en el espacio epidural de la columna puede resultar en graves eventos adversos, como la pérdida de la visión, derrame cerebral, parálisis y muerte.

PDUFA VII: Fiscal Years 2023 – 2027
Mon, 25 Jan 2021 13:23:26 EST

  Prescription Drug User Fee Act (PDUFA) that provides FDA with the necessary resources to maintain a predictable and efficient review process for human drug and biologic products.

Global Generic Drug Affairs
Mon, 25 Jan 2021 13:06:26 EST

  FDA’s Office of Generic Drugs (OGD) ensures, through a scientific and regulatory process, that Americans have access to safe, effective, and high-quality generic drugs.

CDER Small Business & Industry Assistance (SBIA)
Mon, 25 Jan 2021 11:40:24 EST

  This site visit program is designed to offer experiential and firsthand learning opportunities that will provide OPQ staff with a better understanding of the pharmaceutical industry and its operations, as well as the challenges that impact a drug’s developmental program and commercial life cycle. The goal of these visits is to provide OPQ staff exposure to the drug development and manufacturing processes in industry; therefore, a tour of pharmaceutical company facilities in operational status is an integral part of the experience.

Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics
Mon, 25 Jan 2021 11:12:16 EST

  Final Guidance for Industry: Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics, updated December 2018

Generic Drug Facilities, Sites and Organization Lists
Mon, 25 Jan 2021 11:04:13 EST

  Generic Drug Facilities, Sites and Organization Lists

CDER Compliance Conference - 01/14/2021 - 01/14/2021
Mon, 25 Jan 2021 11:02:02 EST

  In SBIA’s first conference dedicated to compliance, participants will learn from FDA subject matter experts on a range of drug compliance topics including compounding in cleanrooms, drug importation requirements, drug supply chain security act implementation, and Risk Evaluation and Mitigation Strategies (REMS) compliance.

Whats New Vaccines Blood Biologics RSS Feed

Biologics Post-Market Activities
Mon, 25 Jan 2021 16:14:46 EST

  Information about biologics post-market activities

Lot Release
Mon, 25 Jan 2021 16:09:10 EST

  Frequent asked questions to address the process of lot samples and protocols before and after applications and supplements are submitted to the agency.

Science & Research (Biologics)
Mon, 25 Jan 2021 15:59:05 EST

  Listing of research programs conducted by CBER scientists and their published scientific articles classified according to the type of work being done: such as general biologics research, allergenics research, blood research, cellular & gene therapy research, tissue research, vaccines research, and xenotransplantation research.

News & Events (Biologics)
Mon, 25 Jan 2021 15:33:13 EST

  Information on recently posted Web pages, meetings, conferences, and workshops.

Workshops, Meetings & Conferences (Biologics)
Mon, 25 Jan 2021 14:36:51 EST

  Information on CBER sponsored or co-sponsored meetings, conferences and workshops about various biologics in order to educate the public and seek the opinion of interested parties.

Resources for You (Biologics)
Mon, 25 Jan 2021 14:33:17 EST

  Biological products include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins.

Consumers (Biologics)
Mon, 25 Jan 2021 14:31:03 EST

  Resources for consumers on biological products.

Healthcare Providers (Biologics)
Mon, 25 Jan 2021 14:26:32 EST

  Resources for Healthcare Providers on biological products.

Industry (Biologics)
Mon, 25 Jan 2021 14:24:45 EST

  CBER’s Manufacturers Assistance and Technical Training Branch provides assistance and training to industry, including large and small manufacturers and trade associations, and to respond to requests for information regarding CBER policies and procedures.

Blood Donor Screening
Mon, 25 Jan 2021 14:18:11 EST

  To protect patients from unsuitable blood and blood products, the FDA has required blood donors to answer specific questions about risk factors that could affect the safety of the donation. FDA requires blood centers to maintain lists of unsuitable donors to prevent further donations from these individuals and that blood is tested for several infectious agents after donation. All tests must be negative before the blood is suitable for transfusion. The agency also inspects all blood facilities at least every two years.

Biologics Research Projects
Mon, 25 Jan 2021 14:02:55 EST

  List of Biologics Research Areas

General Biologics Guidances
Mon, 25 Jan 2021 13:58:48 EST

  This page displays links to General Biologics Guidance documents.

Exporting CBER-Regulated Products
Mon, 25 Jan 2021 13:48:31 EST

  The Division of Case Management (DCM) within CBER's Office of Compliance and Biologics Quality (OCBQ) directs and coordinates CBER's export programs, including review of requests for export of unapproved CBER-regulated products.

International Activities
Mon, 25 Jan 2021 13:45:47 EST

  CBER’s international activities can be categorized in the following functional areas: regulatory harmonization, regulatory capacity building, information sharing, international standards setting, and collaborative research.

Administrative Actions (Biologics)
Mon, 25 Jan 2021 13:42:23 EST

  This is the main page for the CBER Administrative Actions (Biologics).

Advertising & Labeling (Biologics)
Mon, 25 Jan 2021 13:40:17 EST

  Advertising & Labeling (Biologics)

Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics
Mon, 25 Jan 2021 11:12:16 EST

  Final Guidance for Industry: Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics, updated December 2018

Exceptions and Alternative Procedures Approved Under 21 CFR 640.120
Mon, 25 Jan 2021 09:22:15 EST

  Title 21 Code of Federal Regulations 640.120(a) - The Director, Center for Biologics Evaluation and Research, may approve an exception or alternative procedures to any requirement in subchapter F (Biologics) of Chapter I (Parts 600 - 680) of title 21 of the Code of Federal Regulations regarding bloo

Gardasil Vaccine Safety
Mon, 25 Jan 2021 09:10:00 EST

  Gardasil vaccine safety monitoring activities and findings as reported by FDA and CDC.

Remarks by Dr. Hahn to the National Academy of Medicine Town Hall on the COVID-19 Vaccine - 12/04/2020
Sun, 24 Jan 2021 18:16:07 EST

  Remarks by Stephen. Hahn, MD, Commissioner of Food and Drugs, The National Academy of Medicine Town Hall on the COVID-19 Vaccine, Dec. 4, 2020



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