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.

  • 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 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.

  • 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 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.

  • 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.


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 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 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

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

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  • 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.

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