TITLES II AND III OF THE COMPREHENSIVE DRUG ABUSE... Sec. 102 continued
ployee is lawfully acting in the usual course of business or employment, and within the scope of the official duties of such agent or employee, with such hospital or facility, and, with respect to agents or employees of health care facilities specified in clause (iv), only to the extent such individuals are furnishing services pursuant to the contracts or com- pacts described in such clause;
(vi) mere advertisements that do not attempt to facili- tate an actual transaction involving a controlled substance; (vii) a person, entity, or Internet site that is not in the United States and does not facilitate the delivery, distribu- tion, or dispensing of a controlled substance by means of
the Internet to any person in the United States;
(viii) a pharmacy registered under section 303(f) whose dispensing of controlled substances via the Internet con-
(viii) a pharmacy registered under section 303(f) whose dispensing of controlled substances via the Internet con-
sists solely of—
(I) refilling prescriptions for controlled substances
(I) refilling prescriptions for controlled substances
in schedule III, IV, or V, as defined in paragraph (55); or
(II) filling new prescriptions for controlled sub- stances in schedule III, IV, or V, as defined in para- graph (56); or
(ix) any other persons for whom the Attorney General
(ix) any other persons for whom the Attorney General
and the Secretary have jointly, by regulation, found it to be consistent with effective controls against diversion and otherwise consistent with the public health and safety to exempt from the definition of an ‘‘online pharmacy’’.
January 16, 2018
(53) The term ‘‘homepage’’ means the opening or main page or screen of the website of an online pharmacy that is viewable on the Internet.
(54) The term ‘‘practice of telemedicine’’ means, for purposes of this title, the practice of medicine in accordance with applicable Federal and State laws by a practitioner (other than a pharmacist) who is at a location remote from the patient and is communicating with the patient, or health care professional who is treating the pa- tient, using a telecommunications system referred to in section 1834(m) of the Social Security Act, which practice—
(A) is being conducted—
(i) while the patient is being treated by, and physically
(i) while the patient is being treated by, and physically
located in, a hospital or clinic registered under section 303(f); and
(ii) by a practitioner—
(I) acting in the usual course of professional prac-
(I) acting in the usual course of professional prac-
tice;
(II) acting in accordance with applicable State
(II) acting in accordance with applicable State
law; and
(III) registered under section 303(f) in the State in
(III) registered under section 303(f) in the State in
which the patient is located, unless the practitioner— (aa) is exempted from such registration in all
States under section 302(d); or (bb) is—
(AA) an employee or contractor of the De- partment of Veterans Affairs who is acting in the scope of such employment or contract; and
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Sec. 102
TITLES II AND III OF THE COMPREHENSIVE DRUG ABUSE... 18
(BB) registered under section 303(f) in any State or is utilizing the registration of a hospital or clinic operated by the Department of Veterans Affairs registered under section 303(f);
(B) is being conducted while the patient is being treated by, and in the physical presence of, a practitioner—
(i) acting in the usual course of professional practice; (ii) acting in accordance with applicable State law; and (iii) registered under section 303(f) in the State in
which the patient is located, unless the practitioner—
(I) is exempted from such registration in all States
(I) is exempted from such registration in all States
under section 302(d); or (II) is—
(aa) an employee or contractor of the Depart- ment of Veterans Affairs who is acting in the scope of such employment or contract; and
(bb) registered under section 303(f) in any State or is using the registration of a hospital or clinic operated by the Department of Veterans Af- fairs registered under section 303(f);
(C) is being conducted by a practitioner—
(i) who is an employee or contractor of the Indian
(i) who is an employee or contractor of the Indian
Health Service, or is working for an Indian tribe or tribal organization under its contract or compact with the Indian Health Service under the Indian Self-Determination and Education Assistance Act;
(ii) acting within the scope of the employment, con- tract, or compact described in clause (i); and
(iii) who is designated as an Internet Eligible Con- trolled Substances Provider by the Secretary under section 311(g)(2);
(D)(i) is being conducted during a public health emergency
(D)(i) is being conducted during a public health emergency
declared by the Secretary under section 319 of the Public Health Service Act; and
(ii) involves patients located in such areas, and such con- trolled substances, as the Secretary, with the concurrence of the Attorney General, designates, provided that such designa- tion shall not be subject to the procedures prescribed by sub- chapter II of chapter 5 of title 5, United States Code;
(E) is being conducted by a practitioner who has obtained from the Attorney General a special registration under section 311(h);
(F) is being conducted—
(i) in a medical emergency situation—
(i) in a medical emergency situation—
(I) that prevents the patient from being in the physical presence of a practitioner registered under section 303(f) who is an employee or contractor of the Veterans Health Administration acting in the usual course of business and employment and within the scope of the official duties or contract of that employee or contractor;
(II) that prevents the patient from being phys- ically present at a hospital or clinic operated by the
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TITLES II AND III OF THE COMPREHENSIVE DRUG ABUSE... Sec. 102
Department of Veterans Affairs registered under sec- tion 303(f);
(III) during which the primary care practitioner of the patient or a practitioner otherwise practicing tele- medicine within the meaning of this paragraph is un- able to provide care or consultation; and
(IV) that requires immediate intervention by a health care practitioner using controlled substances to prevent what the practitioner reasonably believes in good faith will be imminent and serious clinical con- sequences, such as further injury or death; and
(ii) by a practitioner that—
(ii) by a practitioner that—
(I) is an employee or contractor of the Veterans Health Administration acting within the scope of that employment or contract;
(II) is registered under section 303(f) in any State or is utilizing the registration of a hospital or clinic op- erated by the Department of Veterans Affairs reg- istered under section 303(f); and
(III) issues a controlled substance prescription in this emergency context that is limited to a maximum of a 5-day supply which may not be extended or re- filled; or
(G) is being conducted under any other circumstances that the Attorney General and the Secretary have jointly, by regula- tion, determined to be consistent with effective controls against diversion and otherwise consistent with the public health and safety.
(55) The term ‘‘refilling prescriptions for controlled substances
(55) The term ‘‘refilling prescriptions for controlled substances
January 16, 2018
in schedule III, IV, or V’’—
(A) means the dispensing of a controlled substance in
(A) means the dispensing of a controlled substance in
schedule III, IV, or V in accordance with refill instructions issued by a practitioner as part of a valid prescription that meets the requirements of subsections (b) and (c) of section 309, as appropriate; and
(B) does not include the issuance of a new prescription to an individual for a controlled substance that individual was previously prescribed.
(56) The term ‘‘filling new prescriptions for controlled sub-
(56) The term ‘‘filling new prescriptions for controlled sub-
stances in schedule III, IV, or V’’ means filling a prescription for an individual for a controlled substance in schedule III, IV, or V, if—
(A) the pharmacy dispensing that prescription has pre- viously dispensed to the patient a controlled substance other than by means of the Internet and pursuant to the valid pre- scription of a practitioner that meets the applicable require- ments of subsections (b) and (c) of section 309 (in this para- graph referred to as the ‘‘original prescription’’);
(B) the pharmacy contacts the practitioner who issued the original prescription at the request of that individual to deter- mine whether the practitioner will authorize the issuance of a new prescription for that individual for the controlled sub- stance described in subparagraph (A); and
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