Essentially a copy definition

Essentially a copy means any sterile preparation or nonsterile preparation that is comparable in active ingredients to a commercially available drug product, unless either of the following conditions is met:
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Examples of Essentially a copy in a sentence

  • Steve spent many after school and summer hours driving a tractor.

  • Essentially a copy of one or more approved drug products21428429 Under section 503B(a)(5), a compounded drug product must not be essentially a copy of430 one or more approved drug products.

  • This amount is pre-allocated to iconic events under Council Policy C018 that effectively sets aside$7,000 for the Tropical Festival, $5,000 for the Gassy Dash, $4,000 for Carnarfin and $1,000 for NAIDOC Week.

  • Essentially a copy of one or more approved drug products 380381 Under section 503B(a)(5), a compounded drug product must not be essentially a copy of382 one or more (emphasis added) approved drug products.

  • Landsat 9 (December 2020 launch)• Essentially a copy of Landsat 8, but with importantLandsat 8 (pushbroom)improvements for accuracy and resiliency• Upgrade to fully Class B (Thermal IR instrument was a Class C instrument on Landsat 8); 14-bit data Landsat 10 (~2025-2030 launch)• Technology and user needs studies underway to support an architecture study to commence later this year.

  • The contractor shall ensure that only fresh cooked food is served and stale food is not used.

  • Purpose: The amendments, if adopted, add definitions for "Active pharmaceutical ingredient," "Commercially available product," "Easily substitutable dosage strength," and "Essentially a copy of commercially available product." The Board reviewed and voted to propose the amendments during the November 6, 2018, meeting.

  • Essentially a copy of one or more approved drug products26Under section 503B(a)(5), a compounded drug product must not be essentially a copy of one or more approved drug products.

  • Essentially a copy of one or more approved drug productsUnder section 503B(a)(5), a compounded drug product must not be essentially a copy of one or more (emphasis added) approved drug products.

Related to Essentially a copy

  • Substantially all means a sale, lease, exchange or other transfer involving seventy percent (70%) or more of the fair market value of the assets of such entity; or

  • Manual brachytherapy means a type of brachytherapy in which the brachytherapy sources (e.g., seeds, ribbons) are manually placed topically on or inserted either into the body cavities that are in close proximity to a treatment site or directly into the tissue volume.

  • Principally Above Ground means that at least 51% of the actual cash value of the structure is above ground.

  • Substantially similar means substantially similar in function or capability or otherwise competitive to the products or services being developed, manufactured or sold by the Company during and/or at the end of Executive’s employment, or are marketed to substantially the same type of user or customer as that to which the products and services of the Company are marketed or proposed to be marketed.

  • Animal shelter means a facility operated by a humane society or any society organized under Chapter 1717. of the Revised Code or a dog pound operated pursuant to Chapter 955. of the Revised Code.

  • Facsimile (FAX) prescription means a written prescription or order that is transmitted by an electronic device over telephone lines that sends the exact image to the receiving pharmacy in hard copy form.

  • Maintain Viable Presence means (i) the operation during the term of this Agreement of the facility or facilities for which the tax limitation is granted; and (ii) the Applicant’s maintenance of jobs and wages as required by the Act and as set forth in its Application.

  • Occupational therapy assistant means an individual who has met the requirements of the Board for

  • Records officer means the individual appointed by the chief administrative officer of each governmental entity, or the political subdivision to work with state archives in the care, maintenance, scheduling, designation, classification, disposal, and preservation of records.

  • Dental assistant means any person who, under the supervision of a dentist, performs any extraoral services including infection control or the use of hazardous materials or performs any intraoral services on patients. The term “dental assistant” does not include persons otherwise actively licensed in Iowa to practice dental hygiene or nursing who are engaged in the practice of said profession.

  • Substantially limits means the extent to which the impairment limits an individual’s ability to perform a major life activity as compared to most people in the general population, whether or not an individual chooses to forgo mitigating measures. 42 U.S.C. 126 §12102(4); 28 CFR §35.108(d); 28 CFR §35.105(d) The rules of construction when determining whether an impairment substantially limits performance of a major life activity include:

  • Medical assistant means an unlicensed person who meets the

  • Hard copy means any documents, records, reports, or other data printed on paper.

  • Email Notice means the legal notice summarizing the proposed Settlement terms, as approved by Class Counsel, Facebook’s Counsel, and the Court, to be provided to Class Members (including Minor Subclass Members), under Section 3.3 of this Agreement via electronic mail or the Facebook domain of xxx.xxxxxxxx.xxx. The Email Notice must be substantially similar to the form attached hereto as Exhibit 3.

  • Deputy Assistant Secretary as used in this clause, means the Deputy Assistant Secretary for Federal Contract Compliance, U.S. Department of Labor, or a designee.

  • Women-owned small business concern means a small business concern-

  • Participating Registered Surgical Assistant means a Registered Surgical Assistant who has a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan to provide services to you at the time services are rendered.

  • accessible format copy means a copy of a work or other subject matter in an alternative manner or form that gives a beneficiary person access to the work or other subject matter, including allowing such person to have access as feasibly and comfortably as a person without any of the disabilities or visual impairment referred to in subsection (2) of this section.

  • Veteran-owned small business concern means a small business concern—

  • Ink means a fluid or viscous substance used in the printing industry to produce letters, symbols or illustrations, but not to coat an entire surface.

  • Essential parts means all integral parts and body parts, the removal, alteration, or substitution of

  • Violent student means a student under the age of 21 who:

  • Public organic record means a record that is available to the public for inspection and is:

  • Digital Signature means authentication of any electronic record by a subscriber by means of an electronic method or procedure in accordance with the provisions of section 3;

  • Substantial Assistance means stand-by assistance by another person without which you would not be able to safely and completely perform the ADL.

  • Scan means the complete process of collecting x-ray transmission data for the production of a tomogram. Data can be collected simultaneously during a single scan for the production of one or more tomograms.