LEGEND DRUGS Sample Clauses

LEGEND DRUGS. ...means drugs, biologicals, or compounded prescrip­ tions which are required by law to have a label stating “Caution — Federal Law Prohibits Dispensing Without a Prescription,” and which are approved by the FDA for a particular use or purpose. MAINTENANCE DRUGS means drugs prescribed for chronic conditions and are taken on a regular basis to treat conditions such as high cholesterol, high blood pressure, or asthma. NATIONAL DRUG CODE (NDC). means a national classification system for the identification of drugs. NON‐PARTICIPATING PHARMACY OR NON‐PARTICIPATING PRE­ SCRIPTION DRUG PROVIDER means an independent retail Pharmacy, chain of retail Pharmacies, mail order Pharmacy or specialty drug Pharmacy which has not entered into a written agreement with the Plan to provide phar­ maceutical services to you or an entity which has not been chosen by the Plan to administer its prescription drug program services to you at the time you receive the services. NON-PREFERRED BRAND NAME DRUG. means a Brand Name Drug is identified on the Drug List as a Non-Preferred Brand Name Drug. The Drug List is available by accessing the Plan's website at xxx.xxxxxx.xxx. PARTICIPATING PHARMACY OR PARTICIPATING PRESCRIPTION DRUG PROVIDER means an independent retail Pharmacy, chain of retail Pharmacies, mail order Pharmacy or specialty drug Pharmacy which has en­ tered into a written agreement with the Plan to provide pharmaceutical services to you or an entity chosen by the Plan to administer its prescription drug program services to you at the time you receive the services. PHARMACY means a state and federally licensed establishment where the practice of pharmacy occurs, that is physically separate and apart from any Provider's office, and where Legend Drugs and devices are dispensed un­ der Prescriptions to the general public by a pharmacist licensed to dispense such drugs and devices under the laws of the state in which he practices. PREFERRED BRAND NAME DRUG. means a Brand Name Drug that is identified on the Drug List as a Preferred Brand Name Drug. The Drug List is accessible by accessing the Claim Administrator's website at xxx.xxxxxx.xxx.
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LEGEND DRUGS. Distributor shall, with respect to any Products bearing the legend "CAUTION: FEDERAL LAW RESTRICTS THIS DRUG TO USE BY OR ON THE ORDER OF A LICENSED VETERINARIAN," sell, or caused to be sold, such Products only to, or on the order of, a duly licensed veterinarian for use in the course of the professional practice of such veterinarian or to any other person who is regularly and lawfully engaged in the distribution or dispensing of the Products bearing such legend.
LEGEND DRUGS. Drugs which bear the federal legend: “Caution: federal law prohibits dispensing without a prescription.”
LEGEND DRUGS. ...means drugs, biologicals, or compounded prescrip­ tions which are required by law to have a label stating “Caution — Federal Law Prohibits Dispensing Without a Prescription,” and which are approved by the FDA for a particular use or purpose. MAINTENANCE DRUGS means drugs prescribed for chronic conditions and are taken on a regular basis to treat conditions such as high cholesterol, high blood pressure, or asthma. NATIONAL DRUG CODE (NDC). means a national classification system for the identification of drugs.

Related to LEGEND DRUGS

  • FDA As to each product subject to the jurisdiction of the U.S. Food and Drug Administration (“FDA”) under the Federal Food, Drug and Cosmetic Act, as amended, and the regulations thereunder (“FDCA”) that is manufactured, packaged, labeled, tested, distributed, sold, and/or marketed by the Company or any of its Subsidiaries (each such product, a “Pharmaceutical Product”), such Pharmaceutical Product is being manufactured, packaged, labeled, tested, distributed, sold and/or marketed by the Company in compliance with all applicable requirements under FDCA and similar laws, rules and regulations relating to registration, investigational use, premarket clearance, licensure, or application approval, good manufacturing practices, good laboratory practices, good clinical practices, product listing, quotas, labeling, advertising, record keeping and filing of reports, except where the failure to be in compliance would not have a Material Adverse Effect. There is no pending, completed or, to the Company's knowledge, threatened, action (including any lawsuit, arbitration, or legal or administrative or regulatory proceeding, charge, complaint, or investigation) against the Company or any of its Subsidiaries, and none of the Company or any of its Subsidiaries has received any notice, warning letter or other communication from the FDA or any other governmental entity, which (i) contests the premarket clearance, licensure, registration, or approval of, the uses of, the distribution of, the manufacturing or packaging of, the testing of, the sale of, or the labeling and promotion of any Pharmaceutical Product, (ii) withdraws its approval of, requests the recall, suspension, or seizure of, or withdraws or orders the withdrawal of advertising or sales promotional materials relating to, any Pharmaceutical Product, (iii) imposes a clinical hold on any clinical investigation by the Company or any of its Subsidiaries, (iv) enjoins production at any facility of the Company or any of its Subsidiaries, (v) enters or proposes to enter into a consent decree of permanent injunction with the Company or any of its Subsidiaries, or (vi) otherwise alleges any violation of any laws, rules or regulations by the Company or any of its Subsidiaries, and which, either individually or in the aggregate, would have a Material Adverse Effect. The properties, business and operations of the Company have been and are being conducted in all material respects in accordance with all applicable laws, rules and regulations of the FDA. The Company has not been informed by the FDA that the FDA will prohibit the marketing, sale, license or use in the United States of any product proposed to be developed, produced or marketed by the Company nor has the FDA expressed any concern as to approving or clearing for marketing any product being developed or proposed to be developed by the Company.

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