In general
An online pharmacy shall display in a visible and clear manner on its homepage a statement that it complies with the requirements of this section with respect to the delivery or sale or offer for sale of controlled substances and shall at all times display on the homepage of its Internet site a declaration of compliance in accordance with this section.
Licensure
Each online pharmacy shall comply with the requirements of State law concerning the licensure of pharmacies in each State from which it, and in each State to which it, delivers, distributes, or dispenses or offers to deliver, distribute, or dispense controlled substances by means of the Internet, pursuant to applicable licensure requirements, as determined by each such State.
Internet pharmacy site disclosure information
Notification
In general
Thirty days prior to offering a controlled substance for sale, delivery, distribution, or dispensing, the online pharmacy shall notify the Attorney General, in such form and manner as the Attorney General shall determine, and the State boards of pharmacy in any States in which the online pharmacy offers to sell, deliver, distribute, or dispense controlled substances.
Contents
Existing online pharmacies
An online pharmacy that is already operational as of the effective date of this section, shall notify the Attorney General and applicable State boards of pharmacy in accordance with this subsection not later than 30 days after such date.
Declaration of compliance
On and after the date on which it makes the notification under subsection (d), each online pharmacy shall display on the homepage of its Internet site, in such form as the Attorney General shall by regulation require, a declaration that it has made such notification to the Attorney General.
Reports
Any statement, declaration, notification, or disclosure required under this section shall be considered a report required to be kept under this part.
Notice and designations concerning Indian tribes
In general
25 U.S.C. 5301For purposes of sections 802(52) and 882(c)(6)(B) of this title, the Secretary shall notify the Attorney General, at such times and in such manner as the Secretary and the Attorney General determine appropriate, of the Indian tribes or tribal organizations with which the Secretary has contracted or compacted under the Indian Self-Determination and Education Assistance Act [ et seq.] for the tribes or tribal organizations to provide pharmacy services.
Designations
In general
The Secretary may designate a practitioner described in subparagraph (B) as an Internet Eligible Controlled Substances Provider. Such designations shall be made only in cases where the Secretary has found that there is a legitimate need for the practitioner to be so designated because the population served by the practitioner is in a sufficiently remote location that access to medical services is limited.
Practitioners
25 U.S.C. 5301A practitioner described in this subparagraph is a practitioner 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 under the Indian Self-Determination and Education Assistance Act [ et seq.] with the Indian Health Service.
Special registration for telemedicine
In general
Regulations
Denials
section 824(c) of this titleProceedings to deny an application for registration under this subsection shall be conducted in accordance with .
Reporting of telemedicine by VHA during medical emergency situations
In general
section 802(54)(F) of this titleAny practitioner issuing a prescription for a controlled substance under the authorization to conduct telemedicine during a medical emergency situation described in shall report to the Secretary of Veterans Affairs the authorization of that emergency prescription, in accordance with such requirements as the Secretary of Veterans Affairs shall, by regulation, establish.
To Attorney General
Not later than 30 days after the date that a prescription described in subparagraph (A) is issued, the Secretary of Veterans Affairs shall report to the Attorney General the authorization of that emergency prescription.
Clarification concerning prescription transfers
Any transfer between pharmacies of information relating to a prescription for a controlled substance shall meet the applicable requirements under regulations promulgated by the Attorney General under this chapter.
Pub. L. 91–513, title II, § 311Pub. L. 110–425, § 3(d)(1)122 Stat. 4825Pub. L. 115–271, title III, § 3232132 Stat. 3950Pub. L. 117–215, title I, § 103(b)(1)(F)136 Stat. 2263(, as added , , ; amended , , ; , , .)
Editorial Notes
References in Text
section 309 of Pub. L. 91–513section 829 of this titleSection 309, referred to in subsec. (c)(7), is , which is classified to .
For effective date of this section, referred to in subsec. (d)(3), see Effective Date note below.
Pub. L. 93–63888 Stat. 2203section 5301 of Title 25The Indian Self-Determination and Education Assistance Act, referred to in subsec. (g)(1), (2)(B), is , , , which is classified principally to chapter 46 (§ 5301 et seq.) of Title 25, Indians. For complete classification of this Act to the Code, see Short Title note set out under and Tables.
Pub. L. 91–51384 Stat. 1236section 801 of this titleThis chapter, referred to in subsec. (j), was in the original “this Act”, meaning , , . For complete classification of this Act to the Code, see Short Title note set out under and Tables.
Amendments
Pub. L. 117–2152022—Subsec. (h)(1)(B). substituted “823(g)” for “823(f)” wherever appearing.
Pub. L. 115–2712018—Subsec. (h)(2). amended par. (2) generally. Prior to amendment, text read as follows: “The Attorney General shall, with the concurrence of the Secretary, promulgate regulations specifying the limited circumstances in which a special registration under this subsection may be issued and the procedures for obtaining such a special registration.”
Statutory Notes and Related Subsidiaries
Effective Date
section 3(j) of Pub. L. 110–425section 802 of this titleSection effective 180 days after , except as otherwise provided, see , set out as an Effective Date of 2008 Amendment note under .