Adequate directions for use definition

Adequate directions for use means directions under which a layman can use a drug safely for the purposes for which it is intended. 21 C.F.R. § 201.5.
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Adequate directions for use means directions under which the layman can use a drug
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Adequate directions for use means directions that enable a layperson
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Examples of Adequate directions for use in a sentence

  • Adequate directions for use means di- rections under which the layman can use a device safely and for the purposes for which it is intended.

  • Adequate directions for use can only be written for uses for which the drug has been found by the FDA to be safe and effective.

  • Adequate directions for use" means directions under which the layman can use a drug or device safely and for the purposes for which it is intended.

  • Adequate directions for use means directions that would allow a layperson (i.e., a person who is not a health professional) to use a device safely and for the purposes for which it is intended to be used.FDA regulations at 21 CFR 801.5 set out some factors that are relevant to meeting this requirement.

  • Adequate directions for use means directions under which the layman can use a drug safely and for the purposes for which it is intended.


More Definitions of Adequate directions for use

Adequate directions for use means directions under which a layperson could use a drug safely and effectively for the purposes for which the drug was intended. 21 C.F.R. § 201.5. A prescription drug, by definition, cannot bear adequate directions for use by a layperson because such drug must be administered under the supervision of a licensed practitioner. See 21 U.S.C. § 353(b)(1). Although the FDA, by regulation, has established certain exemptions from the requirement that labeling bear adequate directions for use (see, e.g., 21 C.F.R. § 201.115), Downing Labs’ drug products are unapproved new drugs and do not satisfy the conditions for any of these exemptions.
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Adequate directions for use means directions pursuant to which a layperson can use a drug or device safely and for the purposes for which it is intended;
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Adequate directions for use means directions under which the layman can use a drug safely and for the purpose for which it is intended. A dangerous drug shall be sold at retail only on the order or prescription of a practitioner licensed by law to administer or prescribe such drug, if it bears the legend: "CAUTION -- federal law restricts this drug to use by or on the owner of a licensed veterinarian".
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Adequate directions for use means directions under which the layman can use a medical device safely and for the purposes for which it is intended as defined in 21 C.F.R. §801.5.
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Related to Adequate directions for use

  • instructions for use means the information provided by the manufacturer to inform the user of the device’s intended purpose and proper use and of any precautions to be taken;

  • Federal contract information means information, not intended for public release, that is provided by or generated for the Government under a contract to develop or deliver a product or service to the Government, but not including information provided by the Government to the public (such as on public Web sites) or simple transactional information, such as necessary to process payments.

  • Telemedicine means the delivery of health care services through the use of interactive audio and video technology, permitting real-time communication between the patient at the originating site and the provider, for the purpose of diagnosis, consultation, or treatment. For purposes of this section only, "telemedicine" does not include the use of audio-only telephone, facsimile, or email.

  • Chinese Medicine Practitioner means a Chinese medicine practitioner who is duly registered with the Chinese Medicine Council of Hong Kong pursuant to the Chinese Medicine Ordinance (Cap. 549) of the laws of Hong Kong, but excluding the Insured Person, the Policyholder, an insurance intermediary, an employer, employee, Immediate Family Member or business partner of the Policyholder and/or Insured Person.

  • Abuse Investigation and Protective Services means reporting and investigation activities as required by OAR 407-045-0300 and any subsequent services or supports necessary to prevent further abuse as required by OAR 407-045-0310.

  • Central Contracts and Legal Services means the DSHS central headquarters contracting office, or successor section or office.

  • Centers for Medicare and Medicaid Services or “CMS” means the federal office under the Secretary of the United States Department of Health and Human Services, responsible for the Medicare and Medicaid programs.

  • Information Technology Resources means agency budgetary resources, personnel, equipment, facilities, or services that are primarily used in the management, operation, acquisition, disposition, and transformation, or other activity related to the lifecycle of information technology; acquisitions or interagency agreements that include information technology and the services or equipment provided by such acquisitions or interagency agreements; but does not include grants to third parties which establish or support information technology not operated directly by the Federal Government. (0MB M-15-14)

  • Practice of respiratory care means the (i) administration of pharmacological, diagnostic, and

  • Practice of medicine means the clinical prevention, diagnosis, or treatment of human disease, injury, or condition requiring a physician to obtain and maintain a license in compliance with the Medical Practice Act of a member state.

  • Competent and reliable scientific evidence means tests, analyses, research, studies, or other evidence based on the expertise of professionals in the relevant area, that has been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results.

  • Electronic and Information Resources Accessibility Standards means the accessibility standards for electronic and information resources contained in 1 Texas Administrative Code Chapter 213.

  • Home and community-based services or "HCBS" means Home and Community-Based Services as defined in OAR chapter 411, division 004.

  • Information technology services means services designed to do any of the following:

  • Service Complaints For service problems you should contact your local utility by calling: Vectren Energy Delivery at 800.227.1376. IF YOU SMELL GAS PLEASE MOVE TO A SAFE AREA AND CALL 911 OR YOUR LOCAL UTILITY. Authorization/Representation/Letter of Agency:By entering into this Agreement, you authorize XOOM to act on your behalf under your local utility’s tariffs in accordance with the rules and regulations of the PUCO. You acknowledge that you are the local utility account holder, or a person legally authorized to execute this Agreement on behalf of the account holder for natural gas services and that you are at least eighteen (18) years of age. You agree to authorize XOOM to obtain your credit information and you agree to authorize your local utility to release all information relating to your historical and current natural gas usage, billing and payment history to XOOM or its authorized representatives. You further acknowledge that XOOM has full authority to make all rates and tariff selections necessary to meet its obligations under this Agreement. You may rescind this authorization at any time by contacting XOOM. Neither your social security number, customer account number nor any other customer financial information will be released by XOOM, except where such release is required by court order or by Commission Order or Rule, without your affirmative written consent. Execution of this Agreement shall constitute authorization for the release of this information to XOOM.

  • Practice of radiologic technology means the application of x-rays to human beings for diagnostic or

  • Supplier/Contractor means the individual, firm or company with whom the contract has been concluded for supplying the Goods and Services under the Contract. The Supplier/Contractor shall be deemed to include its successors (approved by the purchaser), representatives, heirs, executors, administrators and permitted;

  • Practice of medicine or osteopathic medicine means the prevention, diagnosis and treatment of

  • Pharmacist services means products, goods, and services, or any combination of products, goods, and services, provided as a part of the practice of pharmacy.

  • Nurse practitioner means an advanced practice registered nurse who is jointly licensed by the

  • Respiratory care practitioner means an individual who practices respiratory care.

  • Project Operations Manual or “POM” means the Project Operations Manual referred to in Section I.B of Schedule 2 to this Agreement, as the said manual may be amended from time to time, with the prior written approval of the Bank, and such term includes any schedules to the POM.

  • Service Locations means those locations set forth on Exhibit B.

  • Medical information means any information about a consumer's medical or mental health treatment or diagnosis by a health care professional.

  • Policies and Procedures means the written policies and procedures of the Client in any way related to the Services, including any such policies and procedures contained in the Organic Documents and the Offering Documents.

  • Credentialing means the process of collecting, assessing, and validating qualifications and other relevant information pertaining to a health care provider to determine eligibility and to deliver Covered Services.