I 
108TH CONGRESS 
1ST SESSION H. R. 3015
To amend the Public Health Service Act to establish an electronic system 
for practitioner monitoring of the dispensing of any schedule II, III, 
or IV controlled substance, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
SEPTEMBER 4, 2003
Mr. WHITFIELD (for himself and Mr. PALLONE) introduced the following bill; 
which was referred to the Committee on Energy and Commerce 
A BILL 
To amend the Public Health Service Act to establish an 
electronic system for practitioner monitoring of the dis-
pensing of any schedule II, III, or IV controlled sub-
stance, and for other purposes.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘National All Schedules 
Prescription Electronic Reporting Act of 2003’’. 
SEC. 2. FINDINGS. 
The Congress finds as follows:
(1) The Harold Rogers Prescription Monitoring 
Program has supplied and will continue to supply 
critically important information and experience re-
garding effective prescription drug monitoring prac-
tices. 
(2) Schedule II, III, and IV controlled sub-
stances have a useful and legitimate medical purpose 
and are necessary to maintain the health and gen-
eral welfare of the American people. 
(3) Schedule II, III, and IV controlled sub-
stances have a moderate to high potential for misuse 
when the prescribing practitioner is unaware of all 
such prescriptions that a patient is receiving, includ-
ing abuse, improper use, and illegal distribution. 
(4) Such misuse imposes substantial and detri-
mental effects on the health and welfare of the 
American people. 
(5) Currently there is no national databank 
that health care practitioners and pharmacists who, 
respectively, prescribe and dispense schedule II, III, 
and IV controlled substances can access to deter-
mine whether a particular prescription is medically 
unnecessary. 
(6) A national electronic databank, supported 
by State databanks where they are established under
State law, would allow providers to access the infor-
mation necessary to ascertain that a particular pre-
scription may be unnecessary or the subject of mis-
use. 
(7) A major portion of the use and misuse of 
schedule II, III, and IV controlled substances in-
volves interstate and foreign commerce. 
(8) Schedule II, III, and IV controlled sub-
stances dispensed intrastate cannot be differentiated 
from schedule II, III, and IV controlled substances 
that are dispensed interstate, and have significant 
interstate effects. 
SEC. 3. ELECTRONIC MONITORING SYSTEM FOR DIS-
PENSING CONTROLLED SUBSTANCES. 
Part P of title III of the Public Health Service Act 
(42 U.S.C. 280g et seq.) is amended by adding after sec-
tion 399N the following: 
‘‘SEC. 399O. ELECTRONIC MONITORING SYSTEM FOR DIS-
PENSING CONTROLLED SUBSTANCES. 
‘‘(a) ESTABLISHMENT.—The Secretary shall estab-
lish an electronic system for practitioner monitoring of the 
dispensing of any schedule II, III, or IV controlled sub-
stance involving patients under their care.
‘‘(b) NO FEE OR TAX.—A practitioner shall not be 
required to pay a fee or tax in connection with the system 
established under subsection (a). 
‘‘(c) REPORTING REQUIREMENT.—Every dispenser 
shall report to the Secretary the information required by 
this section in a timely manner as prescribed by the Sec-
retary, except that reporting shall not be required for—
‘‘(1) a drug administered directly to a patient; 
or 
‘‘(2) a drug dispensed in a quantity limited to 
an amount adequate to treat the patient for 48 
hours or less. 
‘‘(d) INFORMATION TO BE REPORTED.—The Sec-
retary shall determine by regulation the information to be 
reported under subsection (a) for each schedule II, III, 
or IV controlled substance. Such information shall include 
the following: 
‘‘(1) Patient identifier. 
‘‘(2) Drug dispensed. 
‘‘(3) Date of dispensing. 
‘‘(4) Quantity dispensed. 
‘‘(5) Number of refills ordered. 
‘‘(6) Practitioner who signed the prescription. 
‘‘(7) Dispenser.
‘‘(e) ELECTRONIC FORMAT.—The Secretary shall 
specify the electronic format for the reporting of informa-
tion under subsection (a), and may waive the requirement 
of such format with respect to an individual dispenser. 
‘‘(f) PROVISION OF INFORMATION.—The Secretary 
may provide information from the system established 
under subsection (a) and, in the case of a request under 
paragraph (2), compilations of such information, in re-
sponse to a request by—
‘‘(1) a practitioner who certifies that the re-
quested information is for the purpose of providing 
medical or pharmaceutical treatment or evaluating 
the need for such treatment to a bona fide current 
patient; or 
‘‘(2) any local, State, or Federal law enforce-
ment, narcotics control, licensure, disciplinary, or 
program authority, who certifies that—
‘‘(A) the requested information is related 
to an investigation or proceeding involving the 
unlawful diversion or misuse of a schedule II, 
III, or IV substance, and the authority has rea-
sonable cause to conclude that such information 
will further the purpose of the investigation or 
assist in the proceeding; or
‘‘(B) the requested information is nec-
essary for research purposes, but only in the 
case of research to be conducted by the Depart-
ment of Health and Human Services, a State 
medicaid program, or the Drug Enforcement 
Administration, and the intended purpose of the 
research is related to a function committed to 
such agency by law that is not investigative in 
nature. 
‘‘(g) RULE OF CONSTRUCTION.—Nothing in this sec-
tion shall be construed to restrict the ability of any author-
ity, including any local, State, or Federal law enforcement, 
narcotics control, licensure, disciplinary, or program au-
thority, to secure information as otherwise authorized by 
law. 
‘‘(h) LIMITATION.—The Secretary shall make reason-
able efforts to limit the information provided pursuant to 
a valid request under subsection (f) to the minimum nec-
essary to accomplish the intended purpose of the request. 
The Secretary shall also make reasonable efforts to imple-
ment a real-time electronic system, as consistent with any 
available appropriated funds. Reports or communications 
made under subsections (c), (f)(1), or (f)(2)(A) shall not, 
in any event, be made to or by the Secretary more than 
1 week after the antecedent or triggering request or event.
‘‘(i) SUBSEQUENT TRANSFER OF INFORMATION.—A 
person who, pursuant to subsection (f), receives data or 
any report of the system from the Secretary shall not pro-
vide the information to any other person or entity except 
by order of a court of competent jurisdiction or other legal 
authority, by written patient authorization as authorized 
under section 164.508(b) of title 45, Code of Federal Reg-
ulations, or any successor regulations, or as otherwise au-
thorized or permitted by the Health Insurance Portability 
and Accountability Act of 1996. The provisions of sub-
sections (f), (g), and (h) are deemed to comply with the 
Health Insurance Portability and Accountability Act of 
1996 and regulations promulgated thereunder. This sec-
tion shall not prevent the disclosure of information by a 
local, State, or Federal law enforcement, narcotics control, 
licensure, disciplinary, or program authority to district at-
torneys, attorneys general, and others, in furtherance of 
criminal investigations or prosecutions, or licensure, dis-
ciplinary, or other judicial or administrative proceedings 
within their respective jurisdictions. 
‘‘(j) PENALTIES.—
‘‘(1) Any dispenser who knowingly fails to 
transmit information to the Secretary as required by 
this section shall be subject to a civil monetary pen-
alty of $100 for each such failure, and a maximum
civil monetary penalty of $25,000 for such failures 
concerning any particular patient. 
‘‘(2) Any person who seeks or makes a knowing 
disclosure of transmitted information by or to a per-
son not authorized by subsection (f) or the Health 
Insurance Portability and Accountability Act of 
1996, or who knowingly obtains information under 
this section not relating to a bona fide specific cur-
rent patient, shall be subject to a civil monetary pen-
alty of not more than $25,000 for each such viola-
tion. 
‘‘(k) STATE MONITORING SYSTEM.—A State may 
elect to have its own prescription monitoring system, sub-
ject to its own rules and regulations, operating in its juris-
diction to the exclusion of the Federal program created 
by this section, so long as the State system provides the 
information required by this provision to the Federal pro-
gram in a fashion consistent with any requirements issued 
by the Secretary. The Harold Rogers Prescription Moni-
toring Program and the funding it provides may be 
accessed by a State electing to proceed under this provi-
sion. This mechanism is intended to encourage States to 
develop systems that may operate to provide additional in-
formation and experience that will assist in the refinement 
of both the Federal and State programs.
‘‘(l) DEFINITIONS.—For purposes of this section: 
‘‘(1) The term ‘administered directly to a pa-
tient’ means the direct application of a schedule II, 
III, or IV controlled substance to the body of a pa-
tient by a practitioner or by the practitioner’s agent 
in the practitioner’s presence, whether such applica-
tion is by injection, inhalation, ingestion, or any 
other means. 
‘‘(2) The term ‘agent’ means an authorized per-
son who acts on behalf of or at the direction of a 
practitioner. 
‘‘(3) The term ‘dispense’ means to deliver a 
schedule II, III, or IV controlled substance to an ul-
timate user pursuant to the lawful order of a practi-
tioner. 
‘‘(4) The term ‘dispenser’ means a practitioner 
who so delivers a schedule II, III, or IV controlled 
substance to an ultimate user. 
‘‘(5) The term ‘local, State, or Federal law en-
forcement, narcotics control, licensure, disciplinary, 
or program authority’ means—
‘‘(A) any State or local officer authorized 
under State or local law who is employed as an 
investigative agent of a State or local narcotics 
control agency;
‘‘(B) the Drug Enforcement Administra-
tion; 
‘‘(C) the executive director or chief investi-
gator, as designated by each board, of the State 
boards of podiatry, dentistry, pharmacy, med-
ical licensure, osteopathic examiners, veterinary 
medical examiners, nursing, or other boards 
representing appropriate health care-related dis-
ciplines, but only with respect to information 
relevant to licensees of the respective boards; 
‘‘(D) the Department of Health and 
Human Services; 
‘‘(E) a State medicaid program; 
‘‘(F) a properly convened Federal or State 
grand jury or other judicial authority pursuant 
to an appropriately and properly issued sub-
poena; or 
‘‘(G) any contractor selected by the Sec-
retary to establish or maintain the prescription 
database if the Secretary imposes appropriate 
restrictions on such contractor and its per-
sonnel. 
‘‘(6) The term ‘patient identifier’ means the pa-
tient’s—
‘‘(A) full name;