Biological safety cabinet means a containment unit suitable for the preparation of low to moderate risk agents where there is a need for protection of the product, personnel, and environment, according to National Sanitation Foundation (NSF) Standard 49.
Nonprescription drug or "over-the-counter drug" means any
Prescription drug means any drug required by federal law or regulation to be dispensed only
Investigational Medicinal Product means the study drug or control material as defined in the Protocol.
controlled drug means an article or substance prescribed under a regulation to be a controlled drug.
MSAA Indicator Technical Specifications document means, as the context requires, either or both of the document entitled “Multi-Sector Service Accountability Agreement (MSAA) 2019-20 Indicator Technical Specifications November 5, 2018 Version 1.3” and the document entitled “Multi-Sector Service Accountability Agreement (MSAA) 2019-20 Target and Corridor-Setting Guidelines” as they may be amended or replaced from time to time;
Nonprescription drugs means nonnarcotic medicines or drugs which may be sold without a prescription and are prepackaged and labeled for use by the consumer in accordance with the requirements of the statutes and regulations of this state and the federal government;
Web Site Accessibility Standards/Specifications means standards contained in Title 1 Texas Administrative Code Chapter 206.
New drug means: (i) any drug, except a new animal drug or an animal feed bearing or containing
Prescription drugs means drugs, medicine and controlled substances which by law can only be prescribed for human use by persons authorized by law.
Covered drug means any prescription drug that:
Investigational Product means the Study Drug identified above and the control material, as further detailed in the Protocol;
Prescription drug order means a lawful order of a practitioner for a drug or device for a specific patient that is communicated to a pharmacist.
Clinical laboratory means a facility for the microbiological, serological, chemical, hematological, radiobioassay, cytological, immunohematological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.
Manufacturing Know-How means, with respect to the Product or any Variant thereof, the technology, data, designs, processes, methods, specifications and other know-how used in connection with the formulation, manufacture, labeling, packaging, quality control, release testing, and production of the Product, and all ingredients used therein and portions thereof.
Functional Specifications means the descriptions of features and functions of the Application as expressly set forth in Quote.
Web Site Accessibility Standards/Specifications means standards contained in Title 1 Texas Administrative Code Chapter 206.
Drug means (i) articles or substances recognized in the official United States Pharmacopoeia
Biological agent shall mean any pathogenic (disease producing) micro-organism(s) and/or biologically produced toxin(s) (including genetically modified organisms and chemically synthesized toxins) which cause illness and/or death in humans, animals or plants.
Federal work authorization program means any of the electronic verification of work authorization programs operated by the United States Department of Homeland Security or any equivalent federal work authorization program operated by the United States Department of Homeland Security to verify information of newly hired employees, pursuant to the Immigration Reform and Control Act of 1986 (IRCA), D.L. 99-603.
DMF means any drug master file filed with the FDA, and any equivalent filing in other countries or regulatory jurisdictions.
Current Good Manufacturing Practices or “cGMP” means applicable Good Manufacturing Practices as specified in the United States Code of Federal Regulations and/or the EU Good Manufacturing Guidelines, and any successor legislation from time to time, prevailing at the time of the manufacture of the Product.
Program Know-How means all Information and inventions that are conceived, discovered, developed, or otherwise made by or on behalf of either Party or its Affiliates or licensees, solely or jointly with the other Party or its Affiliates or licensees, under this Agreement.
Regulatory Flood Protection Elevation means the “Base Flood Elevation” plus the “Freeboard”. In “Special Flood Hazard Areas” where Base Flood Elevations (BFEs) have been determined, this elevation shall be the BFE plus two (2) feet of freeboard. In “Special Flood Hazard Areas” where no BFE has been established, this elevation shall be at least two (2) feet above the highest adjacent grade.
FFDCA means the United States Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq., as amended from time to time, together with any rules, regulations and requirements promulgated thereunder (including all additions, supplements, extensions, and modifications thereto).
Program Materials means the documents and information provided by the Program Administrator specifying the qualifying EEMs, technology requirements, costs and other Program requirements, which include, without limitation, program guidelines and requirements, application forms and approval letters.