D9. PWS Directives_Handbooks_Policy Hyperlinks.docx

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D.7 PWS Directive, Handbook and Policy Hyperlinks *1.4.20 VHA Directive 2010-014, “Assessment and Management of Veterans Who Have Been Victims of Alleged Acute Sexual Assault” https://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=2177 *1.4.23 - VHA Directive 2011-012, “Medication Reconciliation” http://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2390 *1.4.35 VHA Handbook 1101.02, “Primary Care Management Module” http://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2017 *1.1.41 Handbook 1120.2, "Health Promotion and Disease Prevention Core Program Requirements" http://www1.va.gov/VHAPUBLICATIONS/ViewPublication.asp?pub_ID=1501

*1.4.48 Title 38 CFR §17.107, “VA Response to Disruptive Behavior of Patients” (2010) www.gpo.gov/.../pdf/CFR-2012-title38-vol1-sec17-107.pdf

*1.4.49 Title 38 CFR § 1.203, “Information to be reported to VA Police” (2003) Updated. Site has links to other resourced links. No PDF or attachable file.

https://www.gpo.gov/fdsys/granule/CFR-2011-title38-vol1/CFR-2011-title38-vol1-sec1-203 https://www.dol.gov/agencies/whd/government-contracts/service-contracts

1.2.1 Title 21 C.F.R 900.12(c), “Mammography Quality Standards” (updated) https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=900

1.2.2 Title 21 CFR, “Food and Drugs” Section 1300-end”. https://www.deadiversion.usdoj.gov/21cfr/cfr/index.html

1.2.3 38 USC. Section 7332, regarding a timely special consent for any medical treatment for drug abuse, alcoholism or alcohol abuse, infection with the human immunodeficiency virus (HIV), or sickle cell anemia, to a Veteran with health insurance. A special consent from the Veteran is needed to allow VA to release bills and medical records associated with the treatment. http://www.gpo.gov/fdsys/granule/USCODE-2011-title38/USCODE-2011-title38-partV-chap73-subchapIII-sec7332/content-detail.html

1.2.4 42 CFR Part 482, “Conditions of Participation” http://www.gpo.gov/fdsys/pkg/CFR-2010-title42-vol5/pdf/CFR-2010-title42-vol5-part482.pdf

1.2.5 42 CFR 493.15(b), “Laboratories Performing Waived Tests” http://www.gpo.gov/fdsys/pkg/CFR-2003-title42-vol3/pdf/CFR-2003-title42-vol3-sec493-17.pdf

1.2.6 Clinical Laboratory Improvement Amendments (CLIA): http://cms.hhs.gov/Regulations-and-Guidance/Legislation/CLIA/index.html?redirect=/clia/appendc.asp

1.2.7 Rescinded

1.2.8 VA Directive 1663, “Health Care Resources Contracting – Buying” https://www.va.gov/vapubs/viewPublication.asp?Pub_ID=969&FType=2

1.2.9 VA Directive 6371, “Destruction of Temporary Paper Records” http://www.va.gov/vapubs/viewPublication.asp?Pub_ID=742&FType=2

1.2.10 VHA Record Control Schedule 10-1 http://www1.va.gov/vhapublications/rcs10/rcs10-1.pdf

1.2.11 "Patient Medical Records-VA" 24VA10P2 http://vaww.vhaco.va.gov/privacy/SystemofRecords.htm. https://www.va.gov/privacy/SystemsOfRecords/2001_Privacy_Act_GPO_SOR_compilation.pdf https://www.oprm.va.gov/privacy/privacy_SOR.aspx

1.2.12 VHA Handbook 1101.11(2), “Coordinated Care for Traveling Veterans” http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=3099

1.2.13 VHA Directive 2007-033, "Telephone Service for Clinical Care," http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1605

1.2.14 VHA Directive 2008-015, “Public Access to Automated External Defibrillators (AEDs): Deployment, Training, and Policies for use in VHA Facilities” http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1665

1.2.15 VHA Directive 1088, “Communicating Test Results to Providers and Patients” http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=3148

1.2.16 VHA Directive 2009-038 “VHA National Dual Care Policy” http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=2058

1.2.17 VHA Directive 1033, “Anticoagulation Therapy Management”http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=3129

1.2.18 VHA Directive 1108.08, “VHA Formulary Management Process” https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3291

1.2.19 VHA Directive 1230 “Outpatient Scheduling Processes and Procedures” http://vaww.va.gov/vhapublications/ViewPublication.asp?pub_ID=3218

1.2.20 VHA Directive 2010-014, “Assessment and Management of Veterans Who Have Been Victims of Alleged Acute Sexual Assault” https://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=2177

1.2.21 VHA Directive 2010-033, “Military Sexual Trauma (MST) Program https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=6402

1.2.22 VHA Directive 2010-053, “Patient Record Flags”.

www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2341

1.2.23 VHA Directive 2011-012, “Medication Reconciliation”

http://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2390

1.2.24 VHA Directive 2011-020, “Automated Safety Incident Surveillance and Tracking System (ASISTS)” http://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2407

1.2.25 VHA Directive 1199, “Reporting Cases of Abuse and Neglect” https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=5624 VHA Directive 2012-026, “Sexual Assaults and Other Defined Public Safety Incidents in VHA” The directive specifically includes contracted sites of care and defines procedures specific to patient disruptive behavior. http://vaww.va.gov/vhapublications/ViewPublication.asp?pub_ID=2797

1.2.26 VA Handbook 0730, “Security and Law Enforcement”

http://www1.va.gov/vapubs/viewPublication.asp?Pub_ID=755&FType=2

1.2.27 VHA Directive 1003.4, "VHA Patient Advocacy Program," https://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=5970

1.2.28 VHA Handbook 1004.07, “Financial Relationships between Health Care Professionals and Industry” http://vaww.va.gov/vhapublications/ViewPublication.asp?pub_ID=3059

1.2.29 VHA Handbook 1006.02, “VHA Site Classifications and Definitions” http://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2970

1.2.30 VHA Handbook1050.01, “VHA National Patient Safety Improvement Handbook” http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=2389

1.2.31 VHA Handbook 1100.17, “National Practitioner Data Bank Reports”- http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=2135

1.2.32 VHA Handbook 1100.18, “Reporting and Responding to State Licensing Boards” http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1364

1.2.33 VHA Handbook 1100.19, “Credentialing and Privileging” http://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2910

1.2.34 VHA Directive 1406, Patient Centered Management Module (PCMM) for Primary Care https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=5430

1.2.35 VHA Handbook 1101.10, “Patient Aligned Care Team (PACT)” http://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2977

1.2.36 VHA Handbook 1105.03, “Mammography Program Procedures and Standards” www.va.gov/vhapublications/viewpublication.asp?pub_id=6423

1.2.37 VHA Handbook 1106.01, “Pathology and Laboratory Medicine Service (P&LMS) Procedures” https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=7477

1.2.38 VHA Handbook 1108.05, “Outpatient Pharmacy Services” http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=3209

1.2.39 VHA Directive 1120.02, "Health Promotion and Disease Prevention Core Program Requirements” https://www1.va.gov/vhapublications/ViewPublication.asp?pubID=5965

1.2.40 VHA Handbook 1122, “Podiatric Medical and Surgical Services” https://www1.va.gov/vhapublications/ViewPublication.asp?pubID=5959

1.2.41 VHA Handbook, “1330.01(2) Health Care Services for Women Veterans” https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=5332

1.2.42 VHA Handbook 1160.01, “Uniform Mental Health Services” http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1762

1.2.43 Residents -PLACE HOLDER ONLY- NOT applicable

1.2.44 VHA Handbook 5005, Part 2, Appendix G15, “Licensed Pharmacist Qualification Standards” http://www.va.gov/vapubs/viewPublication.asp?Pub_ID=512&FType=2

1.2.45 Privacy Act of 1974 (5 U.S.C. 552a) as amended http://www.justice.gov/oip/foia_updates/Vol_XVII_4/page2.htm

1.2.46 Title 38 CFR §17.107, “VA Response to Disruptive Behavior of Patients” (2010) www.gpo.gov/.../pdf/CFR-2012-title38-vol1-sec17-107.pdf

1.2.47 Title 38 CFR § 1.203, “Information to be reported to VA Police” (2003) (updated) https://www.gpo.gov/fdsys/granule/CFR-2011-title38-vol1/CFR-2011-title38-vol1-sec1-203

1.2.48 “Guidelines for Preventing Workplace Violence for Health Care and Social Service Workers,” Occupational Safety and Health Administration (OSHA) OSHA 3148-01R 2004) https://www.osha.gov/Publications/osha3148.pdf

1.2.49 “Violence: Occupational Hazards in Hospitals, National Institute for Occupational Safety and Health” (NIOSH) NIOSH 2002-101, April 2002. http://www.cdc.gov/niosh/docs/2002-101/default.html

1.2.50 VA Assistant Secretary OSP Memo, Clarification of Policy for Sexual Assault Reporting, June 2011. http://www.diversity.va.gov/products/files/DAW/v10i05.docx

1.2.51 VHA Directive 1231 Outpatient Clinic Practice Management https://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=3296

1.2.52 VHA Directive 1315 Access to VHA Clinical Programs for Veterans Participating in State-Approved Marijuana Programs https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=5711

1.2.53 VHA Directive 1134 Provision of Medical Statements and Completion of Forms by VA Health Care Providers https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=4300

1.2.54 VHA Directive 1192 Seasonal Influenza Prevention Program for VHA Health Care Personnel https://vaww.va.gov/vhapublications/ViewPublication.asp?pubID=5472

1.2.55 42 CFR 493.15(b), “Laboratories Performing Waived Tests” http://www.gpo.gov/fdsys/pkg/CFR-2003-title42-vol3/pdf/CFR-2003-title42-vol3-sec493-17.pdf

1.2.56 VHA Directive 1605.01, “Privacy and Release of Information” www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3233

1.2.57 VHA Handbook 1108.11, “Clinical Pharmacy Services”

http://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3120

1.2.58 Amendment to VHA Handbook 1100.18, “Reporting and Responding to State Licensing Boards” https://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=5962

1.2.59 VHA Directive 1306, “Querying State Prescription Drug Monitoring Programs (PDMP)” www.va.gov/vhapublications/viewpublication.asp?pub_id=3283

1.2.60 VHA Handbook 1660.03 Conflict of Interest for The Aspects of Contracting for Sharing of Health-Care Resources (HCR) https://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=3152

1.2.61 VA Directive 6008 Acquisition and Management of VA Information Technology Resources https://www.va.gov/vapubs/viewPublication.asp?Pub_ID=891&FType=2

1.2.62 VA Handbook 6500.6 Contract Security https://www.va.gov/vapubs/viewPublication.asp?Pub_ID=471&FType=2

1.2.63 VHA Directive 1300.01 National Viral Hepatitis Program https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=6421

1.2.64 VHA Directive 1210 Chiropractic Care https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=6425

1.2.65 VHA Directive 1341 Providing Health Care for Transgender and Intersex Veterans https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=6431

1.2.66 VHA Directive 1177 Cardiopulmonary Resuscitation, Basic Life Support, and Advanced Cardiac Life Support Training for Staff https://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=5369

1.2.67 VHA Directive 1108.10 Promotion of Drugs and Drug-related Supplies by Pharmaceutical Company Representatives https://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=6435

1.2.68 VHA Directive 1608 Comprehensive Environment of Care (CEOC) Program https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3171

1.2.69 VHA Directive 1003 VHA’s Veteran Customer Service Program https://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=268

1.2.70 VHA Handbook 1003.1 Key Elements of VHA’s Veteran Customer Service Program https://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=422

1.2.71 VHA Handbook 1003.2 Service Recovery in the Veterans Health Administration https://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=433

VHA Directives 2008-043 and 2009-014 are Clinical Pharmacy Services.

Ryan Haight Act -6353-enrolled-bill.pdf

110TH CONGRESS

2D SESSION H. R. 6353

AN ACT

To amend the Controlled Substances Act to address online pharmacies.

Be it enacted by the Senate and House of Representa-1 tives of the United States of America in Congress assembled, 2

•HR 6353 EH

SECTION 1. SHORT TITLE. 1

This Act may be cited as the ‘‘Ryan Haight Online 2

Pharmacy Consumer Protection Act of 2008’’. 3

SEC. 2. REQUIREMENT OF A VALID PRESCRIPTION FOR 4

CONTROLLED SUBSTANCES DISPENSED BY 5

MEANS OF THE INTERNET. 6

Section 309 of the Controlled Substances Act (21 7

U.S.C. 829) is amended by adding at the end the fol-8 lowing: 9

‘‘(e) CONTROLLED SUBSTANCES DISPENSED BY 10

MEANS OF THE INTERNET.— 11

‘‘(1) No controlled substance that is a prescrip-12 tion drug as determined under the Federal Food, 13

Drug, and Cosmetic Act may be delivered, distrib-14 uted, or dispensed by means of the Internet without 15 a valid prescription. 16

‘‘(2) As used in this subsection: 17

‘‘(A) The term ‘valid prescription’ means a 18 prescription that is issued for a legitimate med-19 ical purpose in the usual course of professional 20 practice by— 21

‘‘(i) a practitioner who has conducted 22 at least 1 in-person medical evaluation of 23 the patient; or 24

‘‘(ii) a covering practitioner. 25

‘‘(B)(i) The term ‘in-person medical eval-1 uation’ means a medical evaluation that is con-2 ducted with the patient in the physical presence 3 of the practitioner, without regard to whether 4 portions of the evaluation are conducted by 5 other health professionals. 6

‘‘(ii) Nothing in clause (i) shall be con-7 strued to imply that 1 in-person medical evalua-8 tion demonstrates that a prescription has been 9 issued for a legitimate medical purpose within 10 the usual course of professional practice. 11

‘‘(C) The term ‘covering practitioner’ 12 means, with respect to a patient, a practitioner 13 who conducts a medical evaluation (other than 14 an in-person medical evaluation) at the request 15 of a practitioner who— 16

‘‘(i) has conducted at least 1 in-per-17 son medical evaluation of the patient or an 18 evaluation of the patient through the prac-19 tice of telemedicine, within the previous 24 20 months; and 21

‘‘(ii) is temporarily unavailable to con-22 duct the evaluation of the patient. 23

‘‘(3) Nothing in this subsection shall apply to— 24

‘‘(A) the delivery, distribution, or dis-1 pensing of a controlled substance by a practi-2 tioner engaged in the practice of telemedicine; 3 or 4

‘‘(B) the dispensing or selling of a con-5 trolled substance pursuant to practices as deter-6 mined by the Attorney General by regulation, 7 which shall be consistent with effective controls 8 against diversion.’’. 9

SEC. 3. AMENDMENTS TO THE CONTROLLED SUBSTANCES 10

ACT RELATING TO THE DELIVERY OF CON-11

TROLLED SUBSTANCES BY MEANS OF THE 12

INTERNET. 13

(a) IN GENERAL.—Section 102 of the Controlled 14

Substances Act (21 U.S.C. 802) is amended by adding at 15 the end the following: 16

‘‘(50) The term ‘Internet’ means collectively the myr-17 iad of computer and telecommunications facilities, includ-18 ing equipment and operating software, which comprise the 19 interconnected worldwide network of networks that employ 20 the Transmission Control Protocol/Internet Protocol, or 21 any predecessor or successor protocol to such protocol, to 22 communicate information of all kinds by wire or radio. 23

‘‘(51) The term ‘deliver, distribute, or dispense by 24 means of the Internet’ refers, respectively, to any delivery, 25 distribution, or dispensing of a controlled substance that 1 is caused or facilitated by means of the Internet. 2

‘‘(52) The term ‘online pharmacy’— 3

‘‘(A) means a person, entity, or Internet site, 4 whether in the United States or abroad, that know-5 ingly or intentionally delivers, distributes, or dis-6 penses, or offers or attempts to deliver, distribute, or 7 dispense, a controlled substance by means of the 8

Internet; and 9

‘‘(B) does not include— 10

‘‘(i) manufacturers or distributors reg-11 istered under subsection (a), (b), (d), or (e) of 12 section 303 who do not dispense controlled sub-13 stances to an unregistered individual or entity; 14

‘‘(ii) nonpharmacy practitioners who are 15 registered under section 303(f) and whose ac-16 tivities are authorized by that registration; 17

‘‘(iii) any hospital or other medical facility 18 that is operated by an agency of the United 19

States (including the Armed Forces), provided 20 such hospital or other facility is registered 21 under section 303(f); 22

‘‘(iv) a health care facility owned or oper-23 ated by an Indian tribe or tribal organization, 24 only to the extent such facility is carrying out 25 a contract or compact under the Indian Self- 1

Determination and Education Assistance Act; 2

‘‘(v) any agent or employee of any hospital 3 or facility referred to in clause (iii) or (iv), pro-4 vided such agent or employee is lawfully acting 5 in the usual course of business or employment, 6 and within the scope of the official duties of 7 such agent or employee, with such hospital or 8 facility, and, with respect to agents or employ-9 ees of health care facilities specified in clause 10

(iv), only to the extent such individuals are fur-11 nishing services pursuant to the contracts or 12 compacts described in such clause; 13

‘‘(vi) mere advertisements that do not at-14 tempt to facilitate an actual transaction involv-15 ing a controlled substance; 16

‘‘(vii) a person, entity, or Internet site that 17 is not in the United States and does not facili-18 tate the delivery, distribution, or dispensing of 19 a controlled substance by means of the Internet 20 to any person in the United States; 21

‘‘(viii) a pharmacy registered under section 22

303(f) whose dispensing of controlled sub-23 stances via the Internet consists solely of— 24

‘‘(I) refilling prescriptions for con-1 trolled substances in schedule III, IV, or 2

V, as defined in paragraph (55); or 3

‘‘(II) filling new prescriptions for con-4 trolled substances in schedule III, IV, or 5

V, as defined in paragraph (56); or 6

‘‘(ix) any other persons for whom the At-7 torney General and the Secretary have jointly, 8 by regulation, found it to be consistent with ef-9 fective controls against diversion and otherwise 10 consistent with the public health and safety to 11 exempt from the definition of an ‘online phar-12 macy’. 13

‘‘(53) The term ‘homepage’ means the opening or 14 main page or screen of the website of an online pharmacy 15 that is viewable on the Internet. 16

‘‘(54) The term ‘practice of telemedicine’ means, for 17 purposes of this title, the practice of medicine in accord-18 ance with applicable Federal and State laws by a practi-19 tioner (other than a pharmacist) who is at a location re-20 mote from the patient and is communicating with the pa-21 tient, or health care professional who is treating the pa-22 tient, using a telecommunications system referred to in 23 section 1834(m) of the Social Security Act, which prac-24 tice— 25

‘‘(A) is being conducted— 1

‘‘(i) while the patient is being treated by, 2 and physically located in, a hospital or clinic 3 registered under section 303(f); and 4

‘‘(ii) by a practitioner— 5

‘‘(I) acting in the usual course of pro-6 fessional practice; 7

‘‘(II) acting in accordance with appli-8 cable State law; and 9

‘‘(III) registered under section 303(f) 10 in the State in which the patient is located, 11 unless the practitioner— 12

‘‘(aa) is exempted from such reg-13 istration in all States under section 14

302(d); or 15

‘‘(bb) is— 16

‘‘(AA) an employee or con-17 tractor of the Department of Vet-18 erans Affairs who is acting in the 19 scope of such employment or con-20 tract; and 21

‘‘(BB) registered under sec-22 tion 303(f) in any State or is uti-23 lizing the registration of a hos-24 pital or clinic operated by the 25

Department of Veterans Affairs 1 registered under section 303(f); 2

‘‘(B) is being conducted while the patient is 3 being treated by, and in the physical presence of, a 4 practitioner— 5

‘‘(i) acting in the usual course of profes-6 sional practice; 7

‘‘(ii) acting in accordance with applicable 8

State law; and 9

‘‘(iii) registered under section 303(f) in the 10

State in which the patient is located, unless the 11 practitioner— 12

‘‘(I) is exempted from such registra-13 tion in all States under section 302(d); or 14

‘‘(II) is— 15

‘‘(aa) an employee or contractor 16 of the Department of Veterans Affairs 17 who is acting in the scope of such em-18 ployment or contract; and 19

‘‘(bb) registered under section 20

303(f) in any State or is using the 21 registration of a hospital or clinic op-22 erated by the Department of Veterans 23

Affairs registered under section 24

303(f); 25

‘‘(C) is being conducted by a practitioner— 1

‘‘(i) who is an employee or contractor of 2 the Indian Health Service, or is working for an 3

Indian tribe or tribal organization under its 4 contract or compact with the Indian Health 5

Service under the Indian Self-Determination 6 and Education Assistance Act; 7

‘‘(ii) acting within the scope of the employ-8 ment, contract, or compact described in clause 9

(i); and 10

‘‘(iii) who is designated as an Internet Eli-11 gible Controlled Substances Provider by the 12

Secretary under section 311(g)(2); 13

‘‘(D)(i) is being conducted during a public 14 health emergency declared by the Secretary under 15 section 319 of the Public Health Service Act; and 16

‘‘(ii) involves patients located in such areas, and 17 such controlled substances, as the Secretary, with 18 the concurrence of the Attorney General, designates, 19 provided that such designation shall not be subject 20 to the procedures prescribed by subchapter II of 21 chapter 5 of title 5, United States Code; 22

‘‘(E) is being conducted by a practitioner who 23 has obtained from the Attorney General a special 24 registration under section 311(h); 25

‘‘(F) is being conducted— 1

‘‘(i) in a medical emergency situation— 2

‘‘(I) that prevents the patient from 3 being in the physical presence of a practi-4 tioner registered under section 303(f) who 5 is an employee or contractor of the Vet-6 erans Health Administration acting in the 7 usual course of business and employment 8 and within the scope of the official duties 9 or contract of that employee or contractor; 10

‘‘(II) that prevents the patient from 11 being physically present at a hospital or 12 clinic operated by the Department of Vet-13 erans Affairs registered under section 14

303(f); 15

‘‘(III) during which the primary care 16 practitioner of the patient or a practitioner 17 otherwise practicing telemedicine within 18 the meaning of this paragraph is unable to 19 provide care or consultation; and 20

‘‘(IV) that requires immediate inter-21 vention by a health care practitioner using 22 controlled substances to prevent what the 23 practitioner reasonably believes in good 24 faith will be imminent and serious clinical 25 consequences, such as further injury or 1 death; and 2

‘‘(ii) by a practitioner that— 3

‘‘(I) is an employee or contractor of 4 the Veterans Health Administration acting 5 within the scope of that employment or 6 contract; 7

‘‘(II) is registered under section 8

303(f) in any State or is utilizing the reg-9 istration of a hospital or clinic operated by 10 the Department of Veterans Affairs reg-11 istered under section 303(f); and 12

‘‘(III) issues a controlled substance 13 prescription in this emergency context that 14 is limited to a maximum of a 5-day supply 15 which may not be extended or refilled; or 16

‘‘(G) is being conducted under any other cir-17 cumstances that the Attorney General and the Sec-18 retary have jointly, by regulation, determined to be 19 consistent with effective controls against diversion 20 and otherwise consistent with the public health and 21 safety. 22

‘‘(55) The term ‘refilling prescriptions for controlled 23 substances in schedule III, IV, or V’— 24

‘‘(A) means the dispensing of a controlled sub-1 stance in schedule III, IV, or V in accordance with 2 refill instructions issued by a practitioner as part of 3 a valid prescription that meets the requirements of 4 subsections (b) and (c) of section 309, as appro-5 priate; and 6

‘‘(B) does not include the issuance of a new 7 prescription to an individual for a controlled sub-8 stance that individual was previously prescribed. 9

‘‘(56) The term ‘filling new prescriptions for con-10 trolled substances in schedule III, IV, or V’ means filling 11 a prescription for an individual for a controlled substance 12 in schedule III, IV, or V, if— 13

‘‘(A) the pharmacy dispensing that prescription 14 has previously dispensed to the patient a controlled 15 substance other than by means of the Internet and 16 pursuant to the valid prescription of a practitioner 17 that meets the applicable requirements of sub-18 sections (b) and (c) of section 309 (in this para-19 graph referred to as the ‘original prescription’); 20

‘‘(B) the pharmacy contacts the practitioner 21 who issued the original prescription at the request of 22 that individual to determine whether the practitioner 23 will authorize the issuance of a new prescription for 24 that individual for the controlled substance described 1 in subparagraph (A); and 2

‘‘(C) the practitioner, acting in the usual course 3 of professional practice, determines there is a legiti-4 mate medical purpose for the issuance of the new 5 prescription.’’. 6

(b) REGISTRATION REQUIREMENTS.—Section 303(f) 7 of the Controlled Substances Act (21 U.S.C. 823(f)) is 8 amended in the matter preceding paragraph (1)— 9

(1) in the first sentence, by adding after 10

‘‘schedule II, III, IV, or V’’ the following: ‘‘and shall 11 modify the registrations of pharmacies so registered 12 to authorize them to dispense controlled substances 13 by means of the Internet’’; and 14

(2) in the second sentence, by striking ‘‘if he 15 determines that the issuance of such registration’’ 16 and inserting ‘‘or such modification of registration if 17 the Attorney General determines that the issuance of 18 such registration or modification’’. 19

(c) REPORTING REQUIREMENTS.—Section 307(d) of 20 the Controlled Substances Act (21 U.S.C. 827(d)) is 21 amended by— 22

(1) striking ‘‘(d) Every’’ and inserting ‘‘(d)(1) 23

Every’’; and 24

(2) adding at the end the following: 25

‘‘(2) Each pharmacy with a modified registration 1 under section 303(f) that authorizes the dispensing of con-2 trolled substances by means of the Internet shall report 3 to the Attorney General the controlled substances it dis-4 penses, in the amount specified, and in such time and 5 manner as the Attorney General by regulation shall re-6 quire, except that the Attorney General, under this para-7 graph, may not require any pharmacy to report any infor-8 mation other than the total quantity of each controlled 9 substance that the pharmacy has dispensed each month. 10

For purposes of this paragraph, no reporting shall be re-11 quired unless the pharmacy has met 1 of the following 12 thresholds in the month for which the reporting is re-13 quired: 14

‘‘(A) 100 or more prescriptions dispensed. 15

‘‘(B) 5,000 or more dosage units of all con-16 trolled substances combined.’’. 17

(d) ONLINE PRESCRIPTION REQUIREMENTS.— 18

(1) IN GENERAL.—The Controlled Substances 19

Act is amended by inserting after section 310 (21 20

U.S.C. 830) the following: 21

‘‘ADDITIONAL REQUIREMENTS RELATING TO ONLINE 22

PHARMACIES AND TELEMEDICINE 23

‘‘SEC. 311. (a) IN GENERAL.—An online pharmacy 24 shall display in a visible and clear manner on its homepage 25 a statement that it complies with the requirements of this 26 section with respect to the delivery or sale or offer for sale 1 of controlled substances and shall at all times display on 2 the homepage of its Internet site a declaration of compli-3 ance in accordance with this section. 4

‘‘(b) LICENSURE.—Each online pharmacy shall com-5 ply with the requirements of State law concerning the li-6 censure of pharmacies in each State from which it, and 7 in each State to which it, delivers, distributes, or dispenses 8 or offers to deliver, distribute, or dispense controlled sub-9 stances by means of the Internet, pursuant to applicable 10 licensure requirements, as determined by each such State. 11

‘‘(c) INTERNET PHARMACY SITE DISCLOSURE IN-12

FORMATION.—Each online pharmacy shall post in a visible 13 and clear manner on the homepage of each Internet site 14 it operates, or on a page directly linked thereto in which 15 the hyperlink is also visible and clear on the homepage, 16 the following information for each pharmacy that delivers, 17 distributes, or dispenses controlled substances pursuant to 18 orders made on, through, or on behalf of, that website: 19

‘‘(1) The name and address of the pharmacy as 20 it appears on the pharmacy’s Drug Enforcement Ad-21 ministration certificate of registration. 22

‘‘(2) The pharmacy’s telephone number and 23 email address. 24

‘‘(3) The name, professional degree, and States 1 of licensure of the pharmacist-in-charge, and a tele-2 phone number at which the pharmacist-in-charge 3 can be contacted. 4

‘‘(4) A list of the States in which the pharmacy 5 is licensed to dispense controlled substances. 6

‘‘(5) A certification that the pharmacy is reg-7 istered under this part to deliver, distribute, or dis-8 pense by means of the Internet controlled sub-9 stances. 10

‘‘(6) The name, address, telephone number, 11 professional degree, and States of licensure of any 12 practitioner who has a contractual relationship to 13 provide medical evaluations or issue prescriptions for 14 controlled substances, through referrals from the 15 website or at the request of the owner or operator 16 of the website, or any employee or agent thereof. 17

‘‘(7) The following statement, unless revised by 18 the Attorney General by regulation: ‘This online 19 pharmacy will only dispense a controlled substance 20 to a person who has a valid prescription issued for 21 a legitimate medical purpose based upon a medical 22 relationship with a prescribing practitioner. This in-23 cludes at least one prior in-person medical evalua-24 tion or medical evaluation via telemedicine in accord-1 ance with applicable requirements of section 309.’. 2

‘‘(d) NOTIFICATION.— 3

‘‘(1) IN GENERAL.—Thirty days prior to offer-4 ing a controlled substance for sale, delivery, distribu-5 tion, or dispensing, the online pharmacy shall notify 6 the Attorney General, in such form and manner as 7 the Attorney General shall determine, and the State 8 boards of pharmacy in any States in which the on-9 line pharmacy offers to sell, deliver, distribute, or 10 dispense controlled substances. 11

‘‘(2) CONTENTS.—The notification required 12 under paragraph (1) shall include— 13

‘‘(A) the information required to be posted 14 on the online pharmacy’s Internet site under 15 subsection (c) and shall notify the Attorney 16

General and the applicable State boards of 17 pharmacy, under penalty of perjury, that the 18 information disclosed on its Internet site under 19 subsection (c) is true and accurate; 20

‘‘(B) the online pharmacy’s Internet site 21 address and a certification that the online phar-22 macy shall notify the Attorney General of any 23 change in the address at least 30 days in ad-24 vance; and 25

‘‘(C) the Drug Enforcement Administra-1 tion registration numbers of any pharmacies 2 and practitioners referred to in subsection (c), 3 as applicable. 4

‘‘(3) EXISTING ONLINE PHARMACIES.—An on-5 line pharmacy that is already operational as of the 6 effective date of this section, shall notify the Attor-7 ney General and applicable State boards of phar-8 macy in accordance with this subsection not later 9 than 30 days after such date. 10

‘‘(e) DECLARATION OF COMPLIANCE.—On and after 11 the date on which it makes the notification under sub-12 section (d), each online pharmacy shall display on the 13 homepage of its Internet site, in such form as the Attorney 14

General shall by regulation require, a declaration that it 15 has made such notification to the Attorney General. 16

‘‘(f) REPORTS.—Any statement, declaration, notifica-17 tion, or disclosure required under this section shall be con-18 sidered a report required to be kept under this part. 19

‘‘(g) NOTICE AND DESIGNATIONS CONCERNING IN-20

DIAN TRIBES.— 21

‘‘(1) IN GENERAL.—For purposes of sections 22

102(52) and 512(c)(6)(B), the Secretary shall notify 23 the Attorney General, at such times and in such 24 manner as the Secretary and the Attorney General 25 determine appropriate, of the Indian tribes or tribal 1 organizations with which the Secretary has con-2 tracted or compacted under the Indian Self-Deter-3 mination and Education Assistance Act for the 4 tribes or tribal organizations to provide pharmacy 5 services. 6

‘‘(2) DESIGNATIONS.— 7

‘‘(A) IN GENERAL.—The Secretary may 8 designate a practitioner described in subpara-9 graph (B) as an Internet Eligible Controlled 10

Substances Provider. Such designations shall be 11 made only in cases where the Secretary has 12 found that there is a legitimate need for the 13 practitioner to be so designated because the 14 population served by the practitioner is in a 15 sufficiently remote location that access to med-16 ical services is limited. 17

‘‘(B) PRACTITIONERS.—A practitioner de-18 scribed in this subparagraph is a practitioner 19 who is an employee or contractor of the Indian 20

Health Service, or is working for an Indian 21 tribe or tribal organization under its contract or 22 compact under the Indian Self-Determination 23 and Education Assistance Act with the Indian 24

Health Service. 25

‘‘(h) SPECIAL REGISTRATION FOR TELEMEDICINE.— 1

‘‘(1) IN GENERAL.—The Attorney General may 2 issue to a practitioner a special registration to en-3 gage in the practice of telemedicine for purposes of 4 section 102(54)(E) if the practitioner, upon applica-5 tion for such special registration— 6

‘‘(A) demonstrates a legitimate need for 7 the special registration; and 8

‘‘(B) is registered under section 303(f) in 9 the State in which the patient will be located 10 when receiving the telemedicine treatment, un-11 less the practitioner— 12

‘‘(i) is exempted from such registra-13 tion in all States under section 302(d); or 14

‘‘(ii) is an employee or contractor of 15 the Department of Veterans Affairs who is 16 acting in the scope of such employment or 17 contract and is registered under section 18

303(f) in any State or is utilizing the reg-19 istration of a hospital or clinic operated by 20 the Department of Veterans Affairs reg-21 istered under section 303(f). 22

‘‘(2) REGULATIONS.—The Attorney General 23 shall, with the concurrence of the Secretary, promul-24 gate regulations specifying the limited circumstances 25 in which a special registration under this subsection 1 may be issued and the procedures for obtaining such 2 a special registration. 3

‘‘(3) DENIALS.—Proceedings to deny an appli-4 cation for registration under this subsection shall be 5 conducted in accordance with section 304(c). 6

‘‘(i) REPORTING OF TELEMEDICINE BY VHA DUR-7

ING MEDICAL EMERGENCY SITUATIONS.— 8

‘‘(1) IN GENERAL.—Any practitioner issuing a 9 prescription for a controlled substance under the au-10 thorization to conduct telemedicine during a medical 11 emergency situation described in section 102(54)(F) 12 shall report to the Secretary of Veterans Affairs the 13 authorization of that emergency prescription, in ac-14 cordance with such requirements as the Secretary of 15

Veterans Affairs shall, by regulation, establish. 16

‘‘(2) TO ATTORNEY GENERAL.—Not later than 17

30 days after the date that a prescription described 18 in subparagraph (A) is issued, the Secretary of Vet-19 erans Affairs shall report to the Attorney General 20 the authorization of that emergency prescription. 21

‘‘(j) CLARIFICATION CONCERNING PRESCRIPTION 22

TRANSFERS.—Any transfer between pharmacies of infor-23 mation relating to a prescription for a controlled substance 24 shall meet the applicable requirements under regulations 1 promulgated by the Attorney General under this Act.’’. 2

(2) TECHNICAL AND CONFORMING AMEND-3

MENTS.—The table of contents for the Comprehen-4 sive Drug Abuse Prevention and Control Act of 5

1970 (Public Law 91–513; 84 Stat. 1236) is amend-6 ed by inserting after the item relating to section 310 7 the following: 8

‘‘Sec. 311. Additional requirements relating to online pharmacies and telemedi-cine.’’.

(e) OFFENSES INVOLVING CONTROLLED SUB-9

STANCES IN SCHEDULES III, IV, AND V.—Section 401(b) 10 of the Controlled Substances Act (21 U.S.C. 841(b)) is 11 amended— 12

(1) in paragraph (1)— 13

(A) in subparagraph (D), by striking ‘‘or 14 in the case of any controlled substance in 15 schedule III (other than gamma hydroxybutyric 16 acid), or 30 milligrams of flunitrazepam’’; and 17

(B) by adding at the end the following: 18

‘‘(E)(i) Except as provided in subparagraphs (C) and 19

(D), in the case of any controlled substance in schedule 20

III, such person shall be sentenced to a term of imprison-21 ment of not more than 10 years and if death or serious 22 bodily injury results from the use of such substance shall 23 be sentenced to a term of imprisonment of not more than 24

15 years, a fine not to exceed the greater of that author-1 ized in accordance with the provisions of title 18, United 2

States Code, or $500,000 if the defendant is an individual 3 or $2,500,000 if the defendant is other than an individual, 4 or both. 5

‘‘(ii) If any person commits such a violation after a 6 prior conviction for a felony drug offense has become final, 7 such person shall be sentenced to a term of imprisonment 8 of not more than 20 years and if death or serious bodily 9 injury results from the use of such substance shall be sen-10 tenced to a term of imprisonment of not more than 30 11 years, a fine not to exceed the greater of twice that author-12 ized in accordance with the provisions of title 18, United 13

States Code, or $1,000,000 if the defendant is an indi-14 vidual or $5,000,000 if the defendant is other than an in-15 dividual, or both. 16

‘‘(iii) Any sentence imposing a term of imprisonment 17 under this subparagraph shall, in the absence of such a 18 prior conviction, impose a term of supervised release of 19 at least 2 years in addition to such term of imprisonment 20 and shall, if there was such a prior conviction, impose a 21 term of supervised release of at least 4 years in addition 22 to such term of imprisonment.’’; 23

(2) in paragraph (2)— 24

(A) by striking ‘‘3 years’’ and inserting ‘‘5 1 years’’; 2

(B) by striking ‘‘6 years’’ and inserting 3

‘‘10 years’’; 4

(C) by striking ‘‘after one or more prior 5 convictions’’ and all that follows through ‘‘have 6 become final,’’ and inserting ‘‘after a prior con-7 viction for a felony drug offense has become 8 final,’’; and 9

(3) in paragraph (3)— 10

(A) by striking ‘‘2 years’’ and inserting ‘‘4 11 years’’; 12

(B) by striking ‘‘after one or more convic-13 tions’’ and all that follows through ‘‘have be-14 come final,’’ and inserting ‘‘after a prior convic-15 tion for a felony drug offense has become 16 final,’’; and 17

(C) by adding at the end the following 18

‘‘Any sentence imposing a term of imprison-19 ment under this paragraph may, if there was a 20 prior conviction, impose a term of supervised 21 release of not more than 1 year, in addition to 22 such term of imprisonment.’’. 23

(f) OFFENSES INVOLVING DISPENSING OF CON-24

TROLLED SUBSTANCES BY MEANS OF THE INTERNET.— 25

Section 401 of the Controlled Substances Act (21 U.S.C. 1

841) is amended by adding at the end the following: 2

‘‘(h) OFFENSES INVOLVING DISPENSING OF CON-3

TROLLED SUBSTANCES BY MEANS OF THE INTERNET.— 4

‘‘(1) IN GENERAL.—It shall be unlawful for any 5 person to knowingly or intentionally— 6

‘‘(A) deliver, distribute, or dispense a con-7 trolled substance by means of the Internet, ex-8 cept as authorized by this title; or 9

‘‘(B) aid or abet (as such terms are used 10 in section 2 of title 18, United States Code) 11 any activity described in subparagraph (A) that 12 is not authorized by this title. 13

‘‘(2) EXAMPLES.—Examples of activities that 14 violate paragraph (1) include, but are not limited to, 15 knowingly or intentionally— 16

‘‘(A) delivering, distributing, or dispensing 17 a controlled substance by means of the Internet 18 by an online pharmacy that is not validly reg-19 istered with a modification authorizing such ac-20 tivity as required by section 303(f) (unless ex-21 empt from such registration); 22

‘‘(B) writing a prescription for a controlled 23 substance for the purpose of delivery, distribu-24 tion, or dispensation by means of the Internet 1 in violation of section 309(e); 2

‘‘(C) serving as an agent, intermediary, or 3 other entity that causes the Internet to be used 4 to bring together a buyer and seller to engage 5 in the dispensing of a controlled substance in a 6 manner not authorized by sections 303(f) or 7

309(e); 8

‘‘(D) offering to fill a prescription for a 9 controlled substance based solely on a con-10 sumer’s completion of an online medical ques-11 tionnaire; and 12

‘‘(E) making a material false, fictitious, or 13 fraudulent statement or representation in a no-14 tification or declaration under subsection (d) or 15

(e), respectively, of section 311. 16

‘‘(3) INAPPLICABILITY.— 17

‘‘(A) This subsection does not apply to— 18

‘‘(i) the delivery, distribution, or dis-19 pensation of controlled substances by non-20 practitioners to the extent authorized by 21 their registration under this title; 22

‘‘(ii) the placement on the Internet of 23 material that merely advocates the use of 24 a controlled substance or includes pricing 25 information without attempting to propose 1 or facilitate an actual transaction involving 2 a controlled substance; or 3

‘‘(iii) except as provided in subpara-4 graph (B), any activity that is limited to— 5

‘‘(I) the provision of a tele-6 communications service, or of an 7

Internet access service or Internet in-8 formation location tool (as those 9 terms are defined in section 231 of 10 the Communications Act of 1934); or 11

‘‘(II) the transmission, storage, 12 retrieval, hosting, formatting, or 13 translation (or any combination there-14

of) of a communication, without selec-15 tion or alteration of the content of the 16 communication, except that deletion of 17 a particular communication or mate-18 rial made by another person in a man-19 ner consistent with section 230(c) of 20 the Communications Act of 1934 shall 21 not constitute such selection or alter-22 ation of the content of the commu-23 nication. 24

‘‘(B) The exceptions under subclauses (I) 1 and (II) of subparagraph (A)(iii) shall not 2 apply to a person acting in concert with a per-3 son who violates paragraph (1). 4

‘‘(4) KNOWING OR INTENTIONAL VIOLATION.— 5

Any person who knowingly or intentionally violates 6 this subsection shall be sentenced in accordance with 7 subsection (b).’’. 8

(g) PUBLICATION.—Section 403(c) of the Controlled 9

Substances Act (21 U.S.C. 843(c)) is amended by— 10

(1) striking ‘‘(c)’’ and inserting ‘‘(c)(1)’’; and 11

(2) adding at the end the following: 12

‘‘(2)(A) It shall be unlawful for any person to know-13 ingly or intentionally use the Internet, or cause the Inter-14 net to be used, to advertise the sale of, or to offer to sell, 15 distribute, or dispense, a controlled substance where such 16 sale, distribution, or dispensing is not authorized by this 17 title or by the Controlled Substances Import and Export 18

Act. 19

‘‘(B) Examples of activities that violate subparagraph 20

(A) include, but are not limited to, knowingly or inten-21 tionally causing the placement on the Internet of an adver-22 tisement that refers to or directs prospective buyers to 23

Internet sellers of controlled substances who are not reg-24 istered with a modification under section 303(f). 25

‘‘(C) Subparagraph (A) does not apply to material 1 that either— 2

‘‘(i) merely advertises the distribution of con-3 trolled substances by nonpractitioners to the extent 4 authorized by their registration under this title; or 5

‘‘(ii) merely advocates the use of a controlled 6 substance or includes pricing information without at-7 tempting to facilitate an actual transaction involving 8 a controlled substance.’’. 9

(h) INJUNCTIVE RELIEF.—Section 512 of the Con-10 trolled Substances Act (21 U.S.C. 882) is amended by 11 adding at the end the following: 12

‘‘(c) STATE CAUSE OF ACTION PERTAINING TO ON-13

LINE PHARMACIES.— 14

‘‘(1) IN GENERAL.—In any case in which the 15

State has reason to believe that an interest of the 16 residents of that State has been or is being threat-17 ened or adversely affected by the action of a person, 18 entity, or Internet site that violates the provisions of 19 section 303(f), 309(e), or 311, the State may bring 20 a civil action on behalf of such residents in a district 21 court of the United States with appropriate jurisdic-22 tion— 23

‘‘(A) to enjoin the conduct which violates 24 this section; 25

‘‘(B) to enforce compliance with this sec-1 tion; 2

‘‘(C) to obtain damages, restitution, or 3 other compensation, including civil penalties 4 under section 402(b); and 5

‘‘(D) to obtain such other legal or equi-6 table relief as the court may find appropriate. 7

‘‘(2) SERVICE; INTERVENTION.— 8

‘‘(A) Prior to filing a complaint under 9 paragraph (1), the State shall serve a copy of 10 the complaint upon the Attorney General and 11 upon the United States Attorney for the judi-12 cial district in which the complaint is to be 13 filed. In any case where such prior service is 14 not feasible, the State shall serve the complaint 15 on the Attorney General and the appropriate 16

United States Attorney on the same day that 17 the State’s complaint is filed in Federal district 18 court of the United States. Such proceedings 19 shall be independent of, and not in lieu of, 20 criminal prosecutions or any other proceedings 21 under this title or any other laws of the United 22

States. 23

‘‘(B) Upon receiving notice respecting a 24 civil action pursuant to this section, the United 25

States shall have the right to intervene in such 1 action and, upon so intervening, to be heard on 2 all matters arising therein, and to file petitions 3 for appeal. 4

‘‘(C) Service of a State’s complaint on the 5

United States as required in this paragraph 6 shall be made in accord with the requirements 7 of rule 4(i)(1) of the Federal Rule of Civil Pro-8 cedure. 9

‘‘(3) POWERS CONFERRED BY STATE LAW.— 10

For purposes of bringing any civil action under 11 paragraph (1), nothing in this Act shall prevent an 12 attorney general of a State from exercising the pow-13 ers conferred on the attorney general of a State by 14 the laws of such State to conduct investigations or 15 to administer oaths or affirmations or to compel the 16 attendance of witnesses of or the production of docu-17 mentary or other evidence. 18

‘‘(4) VENUE.—Any civil action brought under 19 paragraph (1) in a district court of the United 20

States may be brought in the district in which the 21 defendant is found, is an inhabitant, or transacts 22 business or wherever venue is proper under section 23

1391 of title 28, United States Code. Process in 24 such action may be served in any district in which 25 the defendant is an inhabitant or in which the de-1 fendant may be found. 2

‘‘(5) NO PRIVATE RIGHT OF ACTION.—No pri-3 vate right of action is created under this subsection. 4

‘‘(6) LIMITATION.—No civil action may be 5 brought under paragraph (1) against— 6

‘‘(A) the United States; 7

‘‘(B) an Indian Tribe or tribal organiza-8 tion, to the extent such tribe or tribal organiza-9 tion is lawfully carrying out a contract or com-10 pact under the Indian Self-Determination and 11

Education Assistance Act; or 12

‘‘(C) any employee of the United States or 13 such Indian tribe or tribal organization, pro-14 vided such agent or employee is acting in the 15 usual course of business or employment, and 16 within the scope of the official duties of such 17 agent or employee therewith.’’. 18

(i) IMPORT AND EXPORT ACT.—Section 1010(b) of 19 the Controlled Substances Import and Export Act (21 20

U.S.C. 960(b)) is amended— 21

(1) in paragraph (4)— 22

(A) by striking ‘‘or any quantity of a con-23 trolled substance in schedule III, IV, or V, (ex-24 cept a violation involving flunitrazepam and ex-25 cept a violation involving gamma hydroxy-1 butyric acid)’’; 2

(B) by inserting ‘‘or’’ before ‘‘less than one 3 kilogram of hashish oil’’; and 4

(C) by striking ‘‘imprisoned’’ and all that 5 follows through the end of the paragraph and 6 inserting ‘‘sentenced in accordance with section 7

401(b)(1)(D).’’; 8

(2) by adding at the end the following: 9

‘‘(5) In the case of a violation of subsection (a) in-10 volving a controlled substance in schedule III, such person 11 shall be sentenced in accordance with section 401(b)(1). 12

‘‘(6) In the case of a violation of subsection (a) in-13 volving a controlled substance in schedule IV, such person 14 shall be sentenced in accordance with section 401(b)(2). 15

‘‘(7) In the case of a violation of subsection (a) in-16 volving a controlled substance in schedule V, such person 17 shall be sentenced in accordance with section 401(b)(3).’’; 18 and 19

(3) in paragraph (3), by striking ‘‘, nor shall a 20 person so sentenced be eligible for parole during the 21 term of such a sentence’’ in the final sentence. 22

(j) EFFECTIVE DATE.— 23

(1) IN GENERAL.—Except as provided in para-24 graph (2), the amendments made by this Act shall 25 take effect 180 days after the date of enactment of 1 this Act. 2

(2) DEFINITION OF PRACTICE OF TELEMEDI-3

CINE.— 4

(A) IN GENERAL.—Until the earlier of 3 5 months after the date on which regulations are 6 promulgated to carry out section 311(h) of the 7

Controlled Substances Act, as amended by this 8

Act, or 15 months after the date of enactment 9 of this Act— 10

(i) the definition of the term ‘‘practice 11 of telemedicine’’ in subparagraph (B) of 12 this paragraph shall apply for purposes of 13 the Controlled Substances Act; and 14

(ii) the definition of the term ‘‘prac-15 tice of telemedicine’’…

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