Label Drugs Clause Samples

The "Label Drugs" clause defines the requirements and responsibilities related to the labeling of pharmaceutical products covered by the agreement. It typically specifies which party is responsible for ensuring that drug labels comply with applicable laws and regulations, and may outline the process for approval or modification of labeling content. For example, it might require that all packaging and inserts include specific information such as dosage instructions, warnings, and manufacturer details. The core function of this clause is to ensure that all drugs are properly labeled to meet regulatory standards and to provide clear, accurate information to end users, thereby reducing legal and safety risks.
Label Drugs. When prescribed for an individual with a life-threatening or chronic and disabling condition or disease benefits are provided for the following: • Off-label drugs; and • Medically Necessary services associated with the administration of such a drug. An off-label drug is one that is prescribed for a use that is different from the use for which that drug has been approved for marketing by the U.S. Food and Drug Administration (FDA). All off-label drugs must be pre-approved by Alliant Health Plans. OTHER PROGRAM PROVISIONS Should the Member, on his or her own accord, choose a Brand Name Drug over a generic drug, regardless of whether a generic equivalent is available and even if the Physician orders the drug to be “dispensed as written,” the Member will pay the Copayment for the Brand Drug as outlined in the Summary of Benefits and Coverage, PLUS the difference in the cost of the two drugs. OUTPATIENT PRESCRIPTION DRUG BENEFITS DO NOT INCLUDE THE FOLLOWING: • Prescription Drug products for any amount dispensed which exceeds the FDA clinically recommended dosing schedule; • Prescription Drugs received through an Internet pharmacy provider or mail-order provider except for Our designated mail order provider; • Newly approved FDA drugs that have not been approved for at least 180 days; • Non-legend vitamins; • Over-the-counter items; • Cosmetic drugs; • Appetite suppressants; • Weight loss products; • Diet supplements; • Syringes (for use other than insulin) except when in coordination with an approved injectable; • Injectables (except with Prior Authorization as required); • The administration or injection of any Prescription Drug or any drugs or medicines; • Prescription Drugs which are entirely consumed or administered at the time and place where the prescription order is issued; • Prescription refills in excess of the number specified by the Physician, or any refill dispensed after one year from the date of the prescription order; • Prescription Drugs for which there is no charge; • Charges for items such as therapeutic devices, artificial appliances, or similar devices, regardless of their intended use; • Prescription Drugs for use while an Inpatient or Outpatient of a Hospital. • Prescription Drugs provided for use in a convalescent care facility or nursing home which are ordinarily furnished by such facility for the care and treatment of Inpatients; • Charges for delivery of any Prescription Drugs; • Drugs and medicines which do not require a prescription...
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Label Drugs. A Prescription Drug prescribed for a use that is not stated in the indications and usage information published by the manufacturer is covered only if the drug is:
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Related to Label Drugs

  • label Prescription Drugs This plan covers off label prescription drugs for cancer or disabling or life-threatening chronic disease if the prescription drug is recognized as a treatment for cancer or disabling or life-threatening chronic disease in accepted medical literature, in accordance with R.I. General Law § 27-55-1.

  • SHOP DRAWINGS, PRODUCT DATA AND SAMPLES 4.12.1 Shop Drawings are drawings, diagrams, schedules and other, data specially prepared for the Work by the Contractor or any Subcontractor, manufacturer, supplier or distributor to illustrate some portion of the Work. 4.12.2 Product Data are illustrations, standard schedules, performance charts, instructions, brochures, diagrams and other information furnished by the Contractor to illustrate a material, product or system for some portion of the Work. 4.12.3 Samples are physical examples which illustrate materials, equipment or workmanship and establish standards by which the Work will be judged. 4.12.4 The Contractor shall review, approve and submit, with reasonable promptness and in such sequence as to cause no delay in the Work or in the work of the State or any separate contractor, all Shop Drawings, Product Data and Samples required by the Contract Documents. 4.12.5 By approving and submitting Shop Drawings, Product Data and Samples, the Contractor represents that he / she has determined and verified all materials, field measurements, and field construction criteria related thereto, or will do so, and that he / she has checked and coordinated the information contained within such submittals with the requirements of the Work and of the Contract Documents. 4.12.6 The Contractor shall not be relieved of responsibility for any deviation from the requirements of the Contract Documents by the Architect's approval of Shop Drawings, Product Data or Samples under Subparagraph 2.2.7 of these General Conditions unless the Contractor has specifically informed the Architect and the State in writing of such deviation at the time of sub- mission and the Architect and the State has given written approval to the specific deviation. The Contractor shall not be relieved from responsibility for errors or omissions in the Shop Drawings, Product Data or Samples by the Architect's approval thereof. 4.12.7 The Contractor shall direct specific attention, in writing or on resubmitted Shop Drawings, Product Data or Samples, to revisions other than those requested by the Architect on previous submittals. 4.12.8 No portion of the Work requiring submission of a Shop Drawing, Product Data or Sample shall be commenced until the submittal has been approved by the Architect as provided in Subparagraph 2.2.7 of these General Conditions. All such portions of the Work shall be in accordance with approved submittals.

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  • Prescription Drug Quantity Limits We limit the quantity of certain prescription drugs that you can get at one time for safety, cost-effectiveness and medical appropriateness reasons. Our clinical criteria for quantity limits are subject to our periodic review and modification. Quantity limits may restrict: • the amount of pills dispensed per thirty (30) day period; • the number of prescriptions ordered in a specified time period; or • the number of prescriptions ordered by a provider, or multiple providers. Our formulary indicates which prescription drugs have a quantity limit. Prescription drugs and diabetic equipment or supplies can be bought from the following types of pharmacies: • Retail pharmacies. These dispense prescription drugs and diabetic equipment or supplies. • Mail order pharmacies. These dispense maintenance and non-maintenance prescription drugs and diabetic equipment or supplies. • Specialty pharmacies. These dispense specialty prescription drugs, defined as such on our formulary. For information about our network retail, mail order, and specialty pharmacies, visit our website or call our Customer Service Department.

  • Prescription Drugs This plan covers prescription drugs and diabetic equipment or supplies. When they are purchased from a pharmacy, prescription drugs and diabetic equipment or supplies are covered as a pharmacy benefit. In most cases, when the prescription drug requires administration by a provider other than a pharmacist (or the FDA approved recommendation is administration by a provider other than a pharmacist), the prescription drug is covered as a medical benefit referred to as “medical prescription drugs”. See subsection B: Medical Benefits - Prescription Drugs Administered by a Provider (other than a pharmacist) below for further information. Please see Pharmacy Benefits subsection A and Medical Benefits subsection B below for information about how these prescription drugs are covered. Prescription drugs and diabetic equipment or supplies are covered when dispensed using the following guidelines: • the prescription must be medically necessary, consistent with the physician’s diagnosis, ordered by a physician whose license allows him or her to order it, filled at a pharmacy whose license allows such a prescription to be filled, and filled according to state and federal laws; • the prescription must consist of legend drugs that require a physician’s prescription under law, or compound medications made up of at least one legend drug requiring a physician’s prescription under law; • the prescription must be dispensed at the proper place of service as determined by our Pharmacy and Therapeutics Committee. For example, certain prescription drugs may only be covered when obtained from a specialty pharmacy; and • the prescription is limited to the quantities authorized by your physician not to exceed the quantity listed in the Summary of Pharmacy Benefits.