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*  FDA's Administrative Destruction Authority
FDASIA section 708 provides that the owner or consignee is responsible for the costs of storage and disposal of the drug. At ... "unapproved drug," and it is illegal for consumers to import unapproved drugs into the U.S. Drugs from foreign sources that are ... Will I be charged for storage and destruction costs if my imported drugs are detained and destroyed?. ... The drug is considered not to represent an unreasonable risk;. *The individual importing the drug verifies in writing that it ...
https://www.fda.gov/ForIndustry/ImportProgram/Resources/ucm494173.htm
*  Blood Notices, Proposed and Final Rules
Distr of Bld Deriv by Reg Bld Establi that Qualify as Hlth Care Entities; Prescrip Drug Mrkting Act of 1987; Prescrip Drug ... Revisions to Labeling and Storage Requirements for Blood and Blood Components, Including Source Plasma; Correction. 10/27/2003 ... U.S. Food and Drug Administration. 10903 New Hampshire Avenue. Silver Spring, MD 20993. 1-888-INFO-FDA (1-888-463-6332). ... Revisions to Labeling and Storage Requirements for Blood and Blood Components, Including Source Plasma. 7/30/2003. ...
https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ActsRulesRegulations/BloodProposedFinalRules/
*  CFR - Code of Federal Regulations Title 21
Subpart L--Handling, Storage, Distribution, and Installation Sec. 820.160 Distribution. (a) Each manufacturer shall establish ... U.S. Food and Drug Administration. 10903 New Hampshire Avenue Silver Spring, MD 20993 Ph. 1-888-INFO-FDA (1-888-463-6332). ... CHAPTER I--FOOD AND DRUG ADMINISTRATION. DEPARTMENT OF HEALTH AND HUMAN SERVICES. ...
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=820.160
*  Validation of Cleaning Processes (7/93)
U.S. Food and Drug Administration. 10903 New Hampshire Avenue. Silver Spring, MD 20993. 1-888-INFO-FDA (1-888-463-6332). ... For example, equipment should be dried before storage, and under no circumstances should stagnant water be allowed to remain in ... When such nonsanitary ball valves are used, as is common in the bulk drug industry, the cleaning process is more difficult. ... This would be particularly true for the bulk drug substance manufacturer where reactors and centrifuges and piping between such ...
https://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074922.htm
*  Biotechnology Inspection Guide (11/91)
Storage and Pooling of Ascites In addition, there should be written procedures that describes the storage temperatures and ... For drugs, the quality of water required depends on the process. Also, because processing usually occurs cold or at room ... Drug Information Journal 23:47 (1989).. *Davis, B.D., Dulbecco, R., Eisen, H. and Ginsberg, H. in Microbiology, 3rd edition. ... FOOD AND DRUG ADMINISTRATION. Note: This document is reference material for investigators and other FDA personnel. The document ...
https://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074181.htm
*  CFR - Code of Federal Regulations Title 21
... storage, or wholesale distribution of prescription drugs; or ... 201.100 Prescription drugs for human use. A drug subject to the ... This reminder labeling shall contain only the proprietary name of the drug product, if any; the established name of the drug ... under which practitioners licensed by law to administer the drug can use the drug safely and for the purposes for which it is ... and precautions under which practitioners licensed by law to administer the drug can use the drug safely and for the purposes ...
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=201.100
*  Where and How to Dispose of Unused Medicines
Is your medicine cabinet full of expired drugs or medications you no longer use? Here's how to dispose of your expired, ... Drug Take Back Programs. The U.S. Drug Enforcement Administration (DEA) sponsors National Prescription Drug Take Back Day in ... Put the mixture in something you can close (a re-sealable zipper storage bag, empty can, or other container) to prevent the ... Flushing Drugs and the Water Supply. Some people wonder if it's okay to flush certain medicines. There are concerns about the ...
https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm101653.htm?xid=nl_EverydayHealthinCoordinationWithFDAFoodDrugandMedicalProductSafety_20180117
*  CPG Sec. 637.100 Plastic Containers for Injectable Animal Drugs
... provides adequate protection against foreseeable external factors in storage and use that can cause deterioration or ... Injectable animal drug products packaged in plastic containers not in accord with 21 CFR 211.94 may be deemed adulterated under ... Numerous veterinary injectable drugs not the subject of approved NADAs are packaged in plastic containers, particularly large ... U.S. Food and Drug Administration. 10903 New Hampshire Avenue. Silver Spring, MD 20993. 1-888-INFO-FDA (1-888-463-6332). ...
https://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm074670.htm
*  Egg Safety: What You Need to Know
Proper storage of eggs can affect both quality and safety.. *Use hard-cooked eggs (in the shell or peeled) within 1 week after ... U.S. Food and Drug Administration. 10903 New Hampshire Avenue. Silver Spring, MD 20993. 1-888-INFO-FDA (1-888-463-6332). ... FDA has put regulations in place to help prevent contamination of eggs on the farm and during shipping and storage, but ... Food and Drug Administration (FDA) estimates that 79,000 cases of foodborne illness and 30 deaths each year are caused by ...
https://www.fda.gov/Food/resourcesForYou/Consumers/ucm077342.htm
*  CFR - Code of Federal Regulations Title 21
... and storage containers that are intended for use as part of an over-the-counter test sample collection system for drugs of ... 864.9700 Blood storage refrigerator and blood storage freezer. (a) Identification. A blood storage refrigerator and a blood ... 864.9900 Cord blood processing system and storage container. (a) Identification. A cord blood processing system and storage ... 864.3250 Specimen transport and storage container. (a) Identification. A specimen transport and storage container, which may be ...
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=864&showFR=1%E2%8A%82partNode=21:8.0.1.1.19.2
*  HUMIRA (adalimumab), Abbott Laboratories - Package Insert
Storage and Stability Do not use beyond the expiration date on the container. HUMIRA must be refrigerated at 2-8 C (36-46 F). ... Drug Interactions MTX reduced adalimumab apparent clearance after single and multiple dosing by 29% and 44% respectively. ... Because many drugs and immunoglobulins are excreted in human milk, and because of the potential for serious adverse reactions ... Drug Interactions HUMIRA has been studied in rheumatoid arthritis patients taking concomitant MTX (see CLINICAL PHARMACOLOGY: ...
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/adalabb123102LB.htm
*  Water for Pharmacuetical Use | FDA
FOOD AND DRUG ADMINISTRATION *ORA/ORO/DEIO/IB*. Date: 12/31/86 Number: 46 Related Program Areas:. Drugs, Biologics, Medical ... If storage tanks are used, determine the capacity, the rate of use, the frequency of flushing and sanitizing the internal ... However, potable water may be used to manufacture drug substances (also known as bulk drugs or bulk pharmaceutical chemicals). ... It is important to know that potable water may not be used to prepare USP dosage form drug products or for laboratory reagents ...
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-technical-guides/water-pharmacuetical-use
*  Orange Book Preface
Preface to Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) provides info on how the book came to ... Drug Innovation. Novel Drug Approvals for 2019 Novel Drug Approvals for 2018 Novel Drug Approvals for 2017 Novel Drug Approvals ... and storage conditions. When such differences are important in the care of a particular patient, it may be appropriate for the ... OTC Drug Product, and Discontinued Drug Product Lists. Listed drugs identified as reference listed drugs represent drug ...
https://www.fda.gov/Drugs/DevelopmentApprovalProcess/ucm079068.htm
*  Frequently Asked Questions About Therapeutic Biological Products
Whereas a new drug application (NDA) is used for drugs subject to the drug approval provisions of the FDC Act, a biologics ... Among other things, safety and purity assessments must consider the storage and testing of cell substrates that are often used ... Biological products subject to the PHS Act also meet the definition of drugs under the Federal Food, Drug and Cosmetic Act (FDC ... like other drugs), can be studied in clinical trials in humans under an investigational new drug application (IND) in ...
https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm113522.htm
*  CFR - Code of Federal Regulations Title 21
The Food and Drug Administration does not encourage indiscriminate addition of nutrients to foods, nor does it consider it ... 1) The nutrient is shown by adequate scientific documentation to have been lost in storage, handling, or processing in a ... U.S. Food and Drug Administration. 10903 New Hampshire Avenue Silver Spring, MD 20993 Ph. 1-888-INFO-FDA (1-888-463-6332). ... 2) Good manufacturing practices and normal storage and handling procedures cannot prevent the loss of such nutrient(s), ...
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=104.20
*  Over-the-Counter Medicines: What's Right for You?
Drug Interactions: A Word to the Wise. Although mild and relatively uncommon, interactions involving OTC drugs can produce ... OTHER INFORMATION': such as storage information. *'INACTIVE INGREDIENTS': substances such as binders, colors, or flavoring ... It's especially important to know about drug interactions if you're taking Rx and OTC drugs at the same time. ... Drugs can pass from a pregnant woman to her unborn baby. A safe amount of medicine for the mother may be too much for the ...
https://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/UnderstandingOver-the-CounterMedicines/Choosingtherightover-the-countermedicineOTCs/ucm150299.htm
*  Pre-Storage Leukocyte Reduction of Whole Blood and Blood Components Intended for Transfusion | FDA
Food and Drug Administration. 10903 New Hampshire Ave WO71-3128. Silver Spring, MD 20993-0002. ... Pre-Storage Leukocyte Reduction of Whole Blood and Blood Components Intended for Transfusion Docket Number:. FDA-2001-D-0254. ... Pre-Storage Leukocyte Reduction of Whole Blood and Blood Components Intended for Transfusion Final Guidance for Industry ... Pre-Storage Leukocyte Reduction of Whole Blood and Blood Components Intended for Transfusion ...
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/pre-storage-leukocyte-reduction-whole-blood-and-blood-components-intended-transfusion
*  CFR - Code of Federal Regulations Title 21
e) Labeling requirements for older prescription drug products. This paragraph applies only to approved prescription drug ... 16 How Supplied/Storage and Handling 17 Patient Counseling Information. (2) Additional nonstandard subheadings that are used to ... i) Prescription drug products for which a new drug application (NDA), biologics license application (BLA), or efficacy ... b) Categories of prescription drugs subject to the labeling content and format requirements in 201.56(d) and 201.57. (1) The ...
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=201.56
*  FDA Drug Safety Communication: FDA warns of severe adverse events with application of Picato (ingenol mebutate) gel for skin...
Wrong storage conditions. All of the cases described the product as having not been kept refrigerated. ... Drug Safety and Availability * Drug Safety and Availability *Recalls of Angiotensin II Receptor Blockers (ARBs) including ... Drugs FDA Drug Safety Communication: FDA warns of severe adverse events with application of Picato (ingenol mebutate) gel for ... Drug Safety and Availability * FDA Drug Safety Communication: FDA warns of severe adverse events with application of Picato ( ...
https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-warns-severe-adverse-events-application-picato-ingenol-mebutate
*  CFR - Code of Federal Regulations Title 21
U.S. Food and Drug Administration. 10903 New Hampshire Avenue Silver Spring, MD 20993 Ph. 1-888-INFO-FDA (1-888-463-6332). ... The procedures shall include provisions for handling, preservation, and storage of equipment, so that its accuracy and fitness ... CHAPTER I--FOOD AND DRUG ADMINISTRATION. DEPARTMENT OF HEALTH AND HUMAN SERVICES. ...
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=820.72
*  FDA identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide...
Drug Safety and Availability * Drug Safety and Availability *Recalls of Angiotensin II Receptor Blockers (ARBs) including ... We are also updating information on proper storage and disposal of these medicines that is currently available on our. Disposal ... The FDA's Drug Review Process: Ensuring Drugs Are Safe and Effective. *Think It Through: Managing the Benefits and Risks of ... Drugs FDA identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide ...
https://www.fda.gov/drugs/drug-safety-and-availability/fda-identifies-harm-reported-sudden-discontinuation-opioid-pain-medicines-and-requires-label-changes?utm_campaign=FDA%20MedWatch-Opioid%20Pain%20Medicines%3A%20Drug%20Safety%20Communication&utm_medium=email&utm_source=Eloqua
*  Instrumed Gmbh - 03/28/2014 | FDA
Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. ยง 321(h), these products are devices ... storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System ... Your firm's response should be sent to: Food and Drug Administration, Center for Devices and Radiological Health, Office of ... investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures medical devices ...
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/instrumed-gmbh-03282014
*  Public Workshop: Identification and Characterization of the Infectious Disease Risks of Human Cells, Tissues, and Cellular and...
U.S. Food and Drug Administration. 10903 New Hampshire Avenue. Silver Spring, MD 20993. 1-888-INFO-FDA (1-888-463-6332). ... My research interests in tissue banking include transmission of diseases in allografts, storage and processing of tissues for ... Food and Drug Administration. He works on a wide range of issues related to the risks and benefits of blood and blood products ... storage and use of blood transfusions, tissue allografts, organs, hematopoietic stem cells, and semen. After specialty training ...
https://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ucm540468.htm
*  CFR - Code of Federal Regulations Title 21
U.S. Food and Drug Administration. 10903 New Hampshire Avenue Silver Spring, MD 20993 Ph. 1-888-INFO-FDA (1-888-463-6332). ... i) Ambient human food storage warehouse/holding facility; (ii) Refrigerated human food warehouse/holding facility; ... CHAPTER I--FOOD AND DRUG ADMINISTRATION. DEPARTMENT OF HEALTH AND HUMAN SERVICES. ...
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=1.232
*  FDA Drug Safety Communication: Special storage and handling requirements must be followed for Pradaxa (dabigatran etexilate...
... is alerting the public to important storage and handling requirements for Pradaxa (dabigatran etexilate mesylate) capsules. ... 03-29-2011] The U.S. Food and Drug Administration (FDA) ... FDA Drug Safety Communication: Special storage and handling ... More in Drug Safety and Availability. Drug Alerts and Statements Medication Guides Drug Safety Communications Drug Shortages. ... Drug Recalls Drug Supply Chain Integrity. FDA Leads Effort to Create a Supply Chain Security Toolkit for Medical Products Drug ...
https://www.fda.gov/Drugs/DrugSafety/ucm248746.htm