Off-label use means the prescription and use of drugs for indications other than those stated in the labeling approved by the federal Food and Drug Administration.[PL 1997, c. 701, §1 (NEW).]
Off-label use means the prescribed use of a drug that's other than that stated in its FDA-approved labeling.
Off-label use means the prescribed use of a drug that’s other than that stated in its FDA-approved labeling. Benefits aren’t available for any drug when the U.S. Food and Drug Administration (FDA) has determined its use to be contra-indicated, or for experimental or investigational drugs not otherwise approved for any indication by the FDA. Prescription Drug Formulary This benefit uses a specific list of covered prescription drugs, sometimes referred to as a “formulary.” Our Pharmacy and Therapeutics Committee, which includes medical practitioners and pharmacists from the community, frequently reviews current medical studies and pharmaceutical information. The Committee then makes recommendations on which drugs are included on our drug lists. The drug lists are updated quarterly based on the Committee’s recommendations. The formulary includes both generic and brand name drugs. Consult the Pharmacy Benefit Guide or RX Search tool listed on our web page, or contact Customer Service for a complete list of your plan’s covered prescription drugs. Your provider may request that you get a non-formulary drug or a dose that is not on the drug list. Under some circumstances, a non-formulary drug may be covered if one of the following is true: There is no formulary drug or alternative available You cannot tolerate the formulary drug The formulary drug or dose is not safe or effective for your condition You must also provide medical records to support your request. We will review your request and let you know in writing if it is approved. If approved, your cost will be as shown on the Summary of Your Costs for formulary generic and brand name drugs. If your request is not approved, the drug will not be covered. If you disagree with our decision you may ask for an appeal. See Complaints and Appeals for details.
Examples of Off-label use in a sentence
If Takeda believes that Off-label Use of Non-Field Product is occurring in any country in the Licensed Territory, Takeda may notify the JSC, providing reasonable evidence for such belief (such as data from a commercially available prescription claims database).
If the JSC cannot agree on: (i) the process and methodology to be implemented by the Parties in tracking sales of Non-Field Products in the Licensed Territory, (ii) the extent of Off-label Use of Non-Field Product, or [***], then in each such case, at the election of either Party, the Parties shall resolve such dispute in accordance with the provisions of Exhibit F.
More Definitions of Off-label use
Off-label use means the use of a federal Food and Drug Administration approved drug for indications other than those stated in labeling that it has approved. The drug need not have been approved for the treatment of cancer or of HIV/AIDS if the use of such drug is supported by one or more citations in (a) the United States Pharmacopeia Drug Information or its successors; (b) the American Hospital Formulary Service Drug Information or its successors; or (c) Peer-reviewed Medical Literature.
Off-label use means use of a prescription medication by a
Off-label use means use of a drug for a condition, or in a dosage or method of administration, not listed in the drug’s FDA-approved labeling for approved use.
Off-label use means the prescribed use of a drug that is other than that stated in the drug’s FDA-approved labeling. Benefits aren’t available for any drug when the FDA has determined its use to be contra-indicated, or for Experimental or Investigational drugs not otherwise approved for any indication by the FDA. Primary Care Provider (“PCP”): A general practitioner, internist, family practitioner, general pediatrician, OB- GYN or Advanced Registered Nurse Practitioner (“ARNP”), chosen by a Subscriber or Dependent to coordinate the Member’s health care needs. Provider: A person who is in a provider category regulated under Title 18 or Chapter 70.127 RCW to practice health care related services consistent with state law. Such persons are considered health care providers only to the extent required by RCW 48.43.045, and only to the extent such services are covered by the provisions of this plan. Also included in this definition is an employee or agent of such a person, acting in the course of and within the scope of his or her employment. Providers also include certain health care facilities and other providers of health care services and supplies, as specifically indicated in the provider category listing below. Health care facilities that are owned and operated by a political subdivision or instrumentality of the State of Washington, and other such facilities, are included as required by state and federal law. Covered licensed or certified categories of providers regulated under Title 18 and Chapter 70.127 RCW include physicians, podiatrists, nurses, physician assistants, social workers, optometrists, psychologists, physical therapists and other professionals engaged in the delivery of health care services, provided that the services they furnish are consistent with state law and the conditions of coverage described elsewhere in this plan are met. The following health care facilities and other providers of health care services and supplies will be considered health care providers for the purposes of this plan as long as they are licensed or certified by the State (unless otherwise stated), and the services they furnish are consistent with their lawful scope of practice, as well as state law, and the conditions of coverage described elsewhere in this plan are met: • Ambulance Companies; • Ambulatory Diagnostic, Treatment and Surgical Facilities; • Audiologists (CCC-A or CCC-MSPA); • Birthing Centers; • Blood Banks; • Community Mental Health Centers; • Drug and Alcohol Tr...
Off-label use means the use of legally marketed and/or FDA-approved drugs, biologics and devices for a purpose or in a manner not already approved by the FDA. Off-label use of a marketed product by a physician, when the intent is the “practice of medicine” (ie diagnosis, cure, mitigation, treatment, or prevention of disease in humans),
Off-label use means the prescription of a drug for a treatment
Off-label use means intentional use of a Product for a medical purpose not in accordance with the authorised product information.