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 that enable a layperson
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Adequate directions for use means directions under which the layman can use a drug
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Examples of Adequate directions for use in a sentence

  • Adequate directions for use re- quire full information of the temporary and emergency use recommended in order for the layman to understand the limitations of usefulness, the reasons therefor, and the importance of adher- ing to the warnings.

  • Adequate directions for use for all commercial feeds containing drugs and for other feeds as necessary for their safe and effective use if required by rule.

  • Adequate directions for use to en- sure compliance with this section.[53 FR 41329, Oct.

  • Adequate directions for use to provide a finished food meeting the limitations prescribed by paragraph (c) of this section.

  • Adequate directions for use re- quire full information of the temporary and emergency use recommended in § 801.410order for the layman to understand the limitations of usefulness, the reasons therefor, and the importance of adher- ing to the warnings.

  • Adequate directions for use including a statement that benzoic acid must be uniformly applied and thoroughly mixed into complete swine feeds and that the complete swine feeds so treated shall be labeled as containing benzoic acid.

  • An ingredient statement is not required for single standardized ingredient feeds which are officially defined.(d) The name and principal mailing address of the man- ufacturer or the person responsible for distributing the com- mercial feed.(e) Adequate directions for use for all commercial feeds containing drugs and for all such other commercial feeds as the department may require by rule as necessary for their safe and effective use.

  • Adequate directions for use for all customer-formula feeds containing drugs and for such other feeds as the commissioner may require by regulation as necessary for their safe and effective use; [PL 1971, c.

  • Adequate directions for use for all commercial feeds containing drugs and for such other feeds as the commissioner may require by regulation as necessary for their safe and effective use;[PL 1971, c.

  • Adequate directions for use including a statement that formic acid must be uniformly applied and thoroughly mixed into complete swine feeds and that the complete swine feeds so treated shall be labeled as containing formic acid.


More Definitions of Adequate directions for use

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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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 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 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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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 exchange of medical information from one site to another via electronic communications for the purpose of providing patient care, treatment, and services.

  • 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.

  • Personal services contract means a contract that, by its express terms or as administered, makes the contractor per- sonnel appear to be, in effect, Government employees (see 37.104).

  • 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.

  • Voice Services means the telecommunications services to be provided to you under Part A and as specified in your Application.

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

  • Personal wireless services means commercial mobile services, unlicensed wireless services, and common carrier wireless exchange access services, as defined by federal laws and regulations.

  • Service Complaints For service problems or complaints, you should contact your local utility by calling: AEP Ohio at 000.000.0000. IN THE EVENT OF AN ENERGY-RELATED EMERGENCY, SUCH AS A POWER OUTAGE OR DOWNED POWER LINE, PLEASE VACATE THE AREA BY A SAFE DISTANCE AND CALL YOUR LOCAL UTILITY or 911. 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 your local utility account holder, or a person legally authorized to execute this Agreement on behalf of the account holder for electricity service and 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 electricity usage, billing and payment history to XOOM or its authorized representatives. You 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

  • 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 a person who is

  • Project Operations Manual means the manual, satisfactory to the Association, and referred to in Section I.C of Schedule 2 to this Agreement, as the same may be amended from time to time with agreement of the Association.

  • Medical information means any individually identifiable information, in electronic or physical form, regarding the individual’s medical history or medical 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.