S 1560 ISCommentsClose CommentsPermalink

112th CONGRESSCommentsClose CommentsPermalink

1st SessionCommentsClose CommentsPermalink

S. 1560CommentsClose CommentsPermalink

To enhance access to controlled substances for residents of institutional long-term care facilities, and for other purposes.CommentsClose CommentsPermalink

IN THE SENATE OF THE UNITED STATESCommentsClose CommentsPermalink

September 14, 2011CommentsClose CommentsPermalink

Mr. KOHL introduced the following bill; which was read twice and referred to the Committee on the JudiciaryCommentsClose CommentsPermalink

A BILLCommentsClose CommentsPermalink

To enhance access to controlled substances for residents of institutional long-term care facilities, and for other purposes.CommentsClose CommentsPermalink

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,CommentsClose CommentsPermalink

SECTION 1. SHORT TITLE.

This Act may be cited as the ‘Nursing Home Resident Pain Relief Act of 2011’.CommentsClose CommentsPermalink

SEC. 2. DEFINITIONS.

Section 102 of the Controlled Substances Act (21 U.S.C. 802) is amended--CommentsClose CommentsPermalink





(1) in paragraph (3), by adding at the end the following: ‘Solely for purposes of section 309(f), the term ‘agent’ includes a facility designee.’; andCommentsClose CommentsPermalink





(2) by adding at the end the following:CommentsClose CommentsPermalink





‘(57) The term ‘institutional long-term care facility’ means--CommentsClose CommentsPermalink





‘(A) a facility certified to participate in the Medicare or Medicaid programs as a nursing facility, as defined in section 1919(a) of the Social Security Act (42 U.S.C. 1396r(a));CommentsClose CommentsPermalink





‘(B) a skilled nursing facility, as defined in section 1819(a) of the Social Security Act (42 U.S.C. 1395i-3(a)); orCommentsClose CommentsPermalink





‘(C) any other entity of a type designated by the Attorney General by regulation.CommentsClose CommentsPermalink





‘(58) The term ‘administrator of an institutional long-term care facility’ means--CommentsClose CommentsPermalink





‘(A) a corporation, company, partnership, or other entity that--CommentsClose CommentsPermalink





‘(i) owns, operates, or manages an institutional long-term care facility; andCommentsClose CommentsPermalink





‘(ii) may be held liable, by law or by consent, for the acts or omissions of the facility designees who are delegated authority by the institutional long-term care facility in connection with the dispensing of controlled substances, including liability for any civil penalties authorized under part D of this title; andCommentsClose CommentsPermalink





‘(B) an individual who--CommentsClose CommentsPermalink





‘(i) has been designated as a co-administrator by an entity described in subparagraph (A);CommentsClose CommentsPermalink





‘(ii) is responsible for managing, supervising, or overseeing the care provided to residents of the institutional long-term care facility or the work of the employees of the institutional long-term care facility; andCommentsClose CommentsPermalink





‘(iii) can be held personally liable, along with the entity described in subparagraph (A), at law or by consent, for the acts or omissions of the facility designees of the institutional long-term care facility in connection with the dispensing of controlled substances, including liability for any civil penalties authorized under section 402.’.CommentsClose CommentsPermalink

SEC. 3. ORAL COMMUNICATION OF PRESCRIPTION INFORMATION FOR RESIDENTS OF INSTITUTIONAL LONG-TERM CARE FACILITIES.

Section 309 of the Controlled Substances Act (21 U.S.C. 829) is amended--CommentsClose CommentsPermalink





(1) in subsection (a), in the first sentence, by inserting ‘except as provided in subsection (f) and’ after ‘without the written prescription of a practitioner’; andCommentsClose CommentsPermalink





(2) by adding at the end the following:CommentsClose CommentsPermalink





‘(f) Controlled Substances Dispensed to Residents of Institutional Long-Term Care Facilities Through the Use of Facility Designees-CommentsClose CommentsPermalink





‘(1) DEFINITIONS- In this subsection--CommentsClose CommentsPermalink





‘(A) the term ‘authorizing agreement’ means a written agreement--CommentsClose CommentsPermalink





‘(i) between--CommentsClose CommentsPermalink





‘(I) an individual practitioner providing medical care to, or supervising medical care being provided to, a resident of an institutional long-term care facility whose care is provided or supervised by the practitioner; andCommentsClose CommentsPermalink





‘(II) an administrator of the institutional long-term care facility;CommentsClose CommentsPermalink





‘(ii) that authorizes the administrator to designate 1 or more qualified individuals to act as facility designees for the purpose of dispensing a controlled substance to the resident; andCommentsClose CommentsPermalink





‘(iii) that includes a written authorization from the practitioner, in a form and manner specified by the Attorney General, that specifies whether the scope of the authorization is for--CommentsClose CommentsPermalink





‘(I) controlled substances in schedule II only; orCommentsClose CommentsPermalink





‘(II) all controlled substances, regardless of schedule; andCommentsClose CommentsPermalink





‘(B) the term ‘facility designee’ means an individual designated by the administrator to whom the authority to act as an agent of a practitioner is delegated under paragraph (3)(A).CommentsClose CommentsPermalink





‘(2) AUTHORIZATION-CommentsClose CommentsPermalink





‘(A) IN GENERAL- A practitioner may enter into an authorizing agreement with an administrator of an institutional long-term care facility if the administrator has--CommentsClose CommentsPermalink





‘(i) adopted written policies and procedures that specify the duties and responsibilities of a facility designee and that require documentation of the acceptance of the duties and responsibilities by a facility designee, consistent with the authorizing agreement; andCommentsClose CommentsPermalink





‘(ii) provided copies of the policies and procedures adopted under clause (i) to the practitioner and to each facility designee.CommentsClose CommentsPermalink





‘(B) RESCISSION OF AUTHORITY- A practitioner may in writing, at any time--CommentsClose CommentsPermalink





‘(i) rescind the authorizing agreement;CommentsClose CommentsPermalink





‘(ii) rescind the authority of a facility designee; orCommentsClose CommentsPermalink





‘(iii) modify the scope of the authorization of a facility designee.CommentsClose CommentsPermalink





‘(3) DELEGATION OF AUTHORITY-CommentsClose CommentsPermalink





‘(A) IN GENERAL- Under an authorizing agreement, an administrator of an institutional long-term care facility may, in accordance with the policies and procedures described in paragraph (2)(A)(i) delegate, in writing, the authority to act as a facility designee to 1 or more health care professionals who are qualified under subparagraph (B).CommentsClose CommentsPermalink





‘(B) REQUIREMENTS FOR QUALIFICATION- To qualify to be a facility designee under subparagraph (A), a health care professional shall be--CommentsClose CommentsPermalink





‘(i) directly employed by, and subject to the supervision and control of, the institutional long-term care facility;CommentsClose CommentsPermalink





‘(ii) lawfully acting within the scope of the employment of the individual; andCommentsClose CommentsPermalink





‘(iii) be a registered nurse, advanced practice nurse, physician’s assistant, or equivalent professional who is licensed, certified, registered, or otherwise permitted to provide professional nursing or health care by the jurisdiction in which the individual is employed.CommentsClose CommentsPermalink





‘(C) REQUIREMENT- A written delegation of authority under subparagraph (A) shall specify, at the option of the practitioner, and in accordance with the authorizing agreement, whether the scope of the authorization is for--CommentsClose CommentsPermalink





‘(i) schedule II controlled substances only; orCommentsClose CommentsPermalink





‘(ii) all controlled substances, regardless of schedule.CommentsClose CommentsPermalink





‘(D) SERVICE AS A FACILITY DESIGNEE- A facility designee shall act in accordance with the policies and procedures described in paragraph (2)(A)(i).CommentsClose CommentsPermalink





‘(E) LIST OF AUTHORIZING AGREEMENTS AND FACILITY DESIGNEES-CommentsClose CommentsPermalink





‘(i) IN GENERAL- An administrator of an institutional long-term care facility shall establish and maintain a current list of--CommentsClose CommentsPermalink





‘(I) all practitioners who have entered into an authorizing agreement with the administrator; andCommentsClose CommentsPermalink





‘(II) all facility designees of each practitioner described in subclause (I) that are employees of the institutional long-term care facility.CommentsClose CommentsPermalink





‘(ii) REQUIREMENTS- The list required under clause (i) shall--CommentsClose CommentsPermalink





‘(I) be--CommentsClose CommentsPermalink

‘(aa) dated upon establishment and each time the list is updated; andCommentsClose CommentsPermalink

‘(bb) made readily available in appropriate places on the premises of the institutional long-term care facility to ensure proper notice of which employees of the institutional long-term care facility are facility designees for which practitioners; andCommentsClose CommentsPermalink

‘(II) include--CommentsClose CommentsPermalink

‘(aa) the name and address of the institutional long-term care facility and the administrator of the institutional long-term care facility;CommentsClose CommentsPermalink

‘(bb) the name of each practitioner who has entered into an authorizing agreement with the administrator of the institutional long-term care facility; andCommentsClose CommentsPermalink

‘(cc) for each practitioner listed under item (bb)--CommentsClose CommentsPermalink

‘(AA) the name of each facility designee; andCommentsClose CommentsPermalink

‘(BB) whether practitioner is providing authorization for schedule II controlled substances only or all controlled substances, regardless of schedule.CommentsClose CommentsPermalink

‘(iii) DISTRIBUTION OF LIST- An administrator of an institutional long-term care facility shall provide the list established under clause (i) to--CommentsClose CommentsPermalink





‘(I) all pharmacies to which the institutional long-term care facility submits prescriptions for dispensing; andCommentsClose CommentsPermalink





‘(II) each practitioner who has entered into an authorizing agreement with the administrator of the institutional long-term care facility.CommentsClose CommentsPermalink





‘(iv) UPDATES- The administrator of an institutional long-term care facility shall promptly update and redistribute a list established under clause (i) if--CommentsClose CommentsPermalink





‘(I) there are any changes to the information required to be included in the list under clause (ii); orCommentsClose CommentsPermalink





‘(II) the authority of any facility designee on the list is rescinded or modified under paragraph (2)(B).CommentsClose CommentsPermalink





‘(F) PROHIBITION OF REDELEGATION OF AUTHORITY- A facility designee may not redelegate any aspect of the authorization of the practitioner to another individual.CommentsClose CommentsPermalink





‘(4) TRANSMISSION BY A FACILITY DESIGNEE OF A VALID ORAL PRESCRIPTION ISSUED BY PRACTITIONER-CommentsClose CommentsPermalink





‘(A) IN GENERAL- Except as provided in subparagraph (D), a practitioner who is providing medical care to, or supervising medical care being provided to, a resident of an institutional long-term care facility may issue an oral prescription for the resident for a controlled substance which is a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), and the oral prescription may be communicated through a facility designee acting under the authorizing agreement of the practitioner.CommentsClose CommentsPermalink





‘(B) POLICIES- A practitioner or a facility designee acting under this subsection shall follow the requirements of this subsection regardless of the schedule of the controlled substance for which an oral prescription is being communicated.CommentsClose CommentsPermalink





‘(C) REQUIREMENTS-CommentsClose CommentsPermalink





‘(i) RESPONSIBILITIES OF PRACTITIONER- In issuing an oral prescription under subparagraph (A), a practitioner shall provide to the facility designee--CommentsClose CommentsPermalink





‘(I) the full name of the resident;CommentsClose CommentsPermalink





‘(II) the drug name, strength, and dosage form;CommentsClose CommentsPermalink





‘(III) the quantity prescribed;CommentsClose CommentsPermalink





‘(IV) the directions for use; andCommentsClose CommentsPermalink





‘(V) the name, address, and Drug Enforcement Administration registration number of the prescribing practitioner.CommentsClose CommentsPermalink





‘(ii) RESPONSIBILITIES OF A FACILITY DESIGNEE- A facility designee that receives an oral prescription issued under subparagraph (A) shall promptly--CommentsClose CommentsPermalink





‘(I) create a document that reduces such oral prescription to writing, which shall include--CommentsClose CommentsPermalink

‘(aa) all of the information provided by the practitioner under clause (i);CommentsClose CommentsPermalink

‘(bb) the legible full name and signature of the facility designee;CommentsClose CommentsPermalink

‘(cc) the name and address of the institutional long-term care facility;CommentsClose CommentsPermalink

‘(dd) the date and time the facility designee received the oral prescription; andCommentsClose CommentsPermalink

‘(ee) an attestation by the covered individual, under penalty of perjury as provided in section 1746 of title 28, United States Code, that--CommentsClose CommentsPermalink

‘(AA) the facility designee has personally spoken with the prescribing practitioner; andCommentsClose CommentsPermalink

‘(BB) all the information required under clause (i) was provided by the practitioner and is accurately and completely recorded by the facility designee on the document; andCommentsClose CommentsPermalink

‘(II) transmit the written document, or a facsimile thereof, to a pharmacy for dispensing.CommentsClose CommentsPermalink





‘(iii) PROHIBITION- A document described in clause (ii)(I) may not be prepared, in whole or in part, by a pharmacy.CommentsClose CommentsPermalink





‘(iv) FACSIMILES- If a facility designee transmits a written document described in clause (ii)(I) by facsimile, the facsimile shall serve as the original written prescription and shall be maintained in accordance with regulations promulgated by the Attorney General.CommentsClose CommentsPermalink





‘(D) SCHEDULE II CONTROLLED SUBSTANCES-CommentsClose CommentsPermalink





‘(i) IN GENERAL- An oral prescription for a schedule II controlled substance shall only be issued through or transmitted by a facility designee under subparagraph (A) during an emergency situation, as described in subsection (a), and the quantity prescribed shall be limited to an amount adequate to treat the patient during the emergency situation.CommentsClose CommentsPermalink





‘(ii) NON-EMERGENCY SITUATIONS- A schedule II controlled substance may only be dispensed for treatment of a resident of an institutional long-term care facility in a non-emergency situation if the prescription is in writing and signed by the prescribing individual practitioner, as described in subsection (a).CommentsClose CommentsPermalink





‘(E) RULE OF CONSTRUCTION- Nothing in this subsection shall be construed to--CommentsClose CommentsPermalink





‘(i) preclude a practitioner from issuing--CommentsClose CommentsPermalink





‘(I) a prescription for a controlled substance and transmitting the prescription directly to the pharmacy, as otherwise authorized in subsections (a), (b), or (c) or by regulations issued by the Attorney General; orCommentsClose CommentsPermalink





‘(II) a written prescription for a controlled substance, signed by the practitioner, and having the written prescription transmitted to the pharmacy through a duly authorized agent of the practitioner (including a facility designee), as otherwise authorized by subsections (a), (b), or (c) of this section or by regulations issued by the Attorney General; orCommentsClose CommentsPermalink





‘(ii) authorize a facility designee to make any determination that underlies any element of a prescription.CommentsClose CommentsPermalink





‘(F) RULEMAKING AUTHORITY- The Attorney General may, by regulation, promulgate rules specifying additional requirements with respect to the formatting, content, and creation of the written document described in subparagraph (C)(ii).CommentsClose CommentsPermalink





‘(G) RECORD OF ORAL PRESCRIPTIONS-CommentsClose CommentsPermalink





‘(i) IN GENERAL- Each practitioner who issues an oral prescription to a facility designee shall--CommentsClose CommentsPermalink





‘(I) create a contemporaneous record of the oral prescription; andCommentsClose CommentsPermalink





‘(II) maintain the record in a written or electronic log at the registered location of the practitioner, in accordance with section 307.CommentsClose CommentsPermalink





‘(ii) CONTENTS AND RETENTION REQUIREMENTS- The Attorney General shall specify by regulation the contents and retention requirements for record required to be kept under clause (i).CommentsClose CommentsPermalink





‘(iii) RESPONSIBILITY OF THE PRACTITIONER- A practitioner shall be responsible for the creation of the contemporaneous record of the oral prescription required under clause (i)(I), and may not delegate or assign any responsibilities under clause (i), in whole or in part, to--CommentsClose CommentsPermalink





‘(I) a pharmacy;CommentsClose CommentsPermalink





‘(II) a facility designee; orCommentsClose CommentsPermalink





‘(III) an institutional long-term care facility (including an employee of the institutional long-term care facility).CommentsClose CommentsPermalink





‘(H) DEFINITION OF ORAL PRESCRIPTION- The Attorney General may, if determined by the Attorney General to be necessary, define by regulation the term ‘oral prescription’ for purposes of this subsection.CommentsClose CommentsPermalink





‘(5) PHARMACY VERIFICATION OF ORAL PRESCRIPTIONS TRANSMITTED BY FACILITY DESIGNEES-CommentsClose CommentsPermalink





‘(A) IN GENERAL- Upon receiving an oral prescription from a practitioner that was reduced to writing and transmitted under paragraph (4), a pharmacy shall--CommentsClose CommentsPermalink





‘(i) determine whether the institutional long-term care facility employee who transmitted the prescription is a facility designee for the prescribing practitioner for the prescribed controlled substance based on the most recent list of the facility designees that the institutional long-term care facility provided to the pharmacy under paragraph (3)(E)(iii); andCommentsClose CommentsPermalink





‘(ii) document the determination under clause (i), which shall include a notation on the prescription document to memorialize that the cross-check was completed that includes--CommentsClose CommentsPermalink





‘(I) the initials of the verifying pharmacist; andCommentsClose CommentsPermalink





‘(II) the date and time of the verification.CommentsClose CommentsPermalink





‘(B) TRANSMISSION TO PRESCRIBING PRACTITIONER- Not later than 72 hours after a pharmacy dispenses a controlled substance pursuant to an oral prescription issued under paragraph (4), the pharmacy shall transmit a copy of the prescription document that the pharmacy received from the facility designee under paragraph (4)(C)(ii), clearly marked as having been dispensed, to the prescribing practitioner.CommentsClose CommentsPermalink





‘(C) PRACTITIONER REQUIREMENT- A practitioner shall--CommentsClose CommentsPermalink





‘(i) endorse, by physically affixing his written signature to the copy of the prescription the pharmacy transmitted to the practitioner under subparagraph (B), if the prescription was issued by the practitioner; andCommentsClose CommentsPermalink





‘(ii) not later than 5 business days after receiving the copy of the prescription from the pharmacy, return the prescription to the pharmacy in accordance with subparagraph (E).CommentsClose CommentsPermalink





‘(D) ENDORSEMENT OF PRESCRIPTION- By endorsing a prescription under subparagraph (C), the practitioner--CommentsClose CommentsPermalink





‘(i) attests that the oral prescription memorialized and transmitted by a facility designee was authorized by the practitioner named on the prescription; andCommentsClose CommentsPermalink





‘(ii) certifies that the prescription information conveyed by the facility designee--CommentsClose CommentsPermalink





‘(I) was accurate;CommentsClose CommentsPermalink





‘(II) matches the information in the record kept by the practitioner under paragraph (4)(G); andCommentsClose CommentsPermalink





‘(III) was based on determinations and instructions made by the practitioner.CommentsClose CommentsPermalink





‘(E) RETURN OF ENDORSED PRESCRIPTION TO PHARMACY- The practitioner may deliver a prescription endorsed under subparagraph (C)(i) to the pharmacy in person, by mail, by facsimile, or by other appropriate means of delivery, except that if the practitioner uses the mail for delivery, the prescription shall be postmarked during the 5-business-day period described in subparagraph (C)(ii).CommentsClose CommentsPermalink





‘(F) ATTACHMENT OF ENDORSEMENT TO PRESCRIPTION- A dispensing pharmacy shall attach a prescription endorsed under subparagraph (C)(i) to the prescription document that the pharmacy received from the facility designee under paragraph (4)(C).CommentsClose CommentsPermalink





‘(G) NONCOMPLIANCE-CommentsClose CommentsPermalink





‘(i) IN GENERAL- If a pharmacy does not receive an endorsed prescription required under this paragraph from a practitioner within the 5-business-day period described in subparagraph (C)(ii), the pharmacy--CommentsClose CommentsPermalink





‘(I) may not dispense any subsequent prescriptions for controlled substances issued by or on behalf of the practitioner for residents at the institutional long-term care facility, unless the prescription is a written prescription issued directly by the practitioner, until the required endorsement of the oral prescription is received; andCommentsClose CommentsPermalink





‘(II) shall note the limitation described in subclause (I) on the most recent copy of the list that the institutional long-term care facility provided to the pharmacy under paragraph (3)(E)(iii).CommentsClose CommentsPermalink





‘(ii) NOTICE TO DEA- A pharmacy shall notify the nearest office of the Drug Enforcement Administration if the pharmacy does not receive an endorsed prescription from a practitioner by the end of the 10-business-day period beginning on the date on which the pharmacy transmitted notice to the practitioner under subparagraph (B).CommentsClose CommentsPermalink





‘(6) RECORDKEEPING-CommentsClose CommentsPermalink





‘(A) IN GENERAL- Each institutional long-term care facility shall--CommentsClose CommentsPermalink





‘(i) maintain a readily retrievable written or electronic logbook, in which it records each instance in which a facility designee memorializes and transmits an oral prescription for a controlled substance to a pharmacy on behalf of a practitioner under paragraph (4); andCommentsClose CommentsPermalink





‘(ii) keep, on the premises of the institutional long-term care facility--CommentsClose CommentsPermalink





‘(I) the logbook described in clause (i); andCommentsClose CommentsPermalink





‘(II) copies of--CommentsClose CommentsPermalink

‘(aa) any authorizing agreements;CommentsClose CommentsPermalink

‘(bb) any policies and procedures issued by the institutional long-term care facility under paragraph (2)(A)(i);CommentsClose CommentsPermalink

‘(cc) any notice of rescission or modification of the authority of a facility designee;CommentsClose CommentsPermalink

‘(dd) each list prepared by the administrator of the institutional long-term care facility under paragraph (3)(E); andCommentsClose CommentsPermalink

‘(ee) all documents created by facility designees to reduce oral prescriptions to writing, under paragraph (4)(C)(ii)(I).CommentsClose CommentsPermalink

‘(B) RETENTION OF COPIES- An institutional long-term care facility shall--CommentsClose CommentsPermalink





‘(i) retain a copy of any document described in subparagraph (A)(ii)(II) until the end of the 5-year period beginning on the date on which the document was created; andCommentsClose CommentsPermalink





‘(ii) whether retained in written or electronic form, make available for inspection and copying by the Attorney General under section 510--CommentsClose CommentsPermalink





‘(I) the logbook described in subparagraph (A)(i); andCommentsClose CommentsPermalink





‘(II) copies of the documents described in subparagraph (A)(ii)(II).CommentsClose CommentsPermalink





‘(C) PROHIBITION- The logbook required under subparagraph (A)(i) may not be prepared, maintained, or updated, in whole or in part, by a pharmacy.CommentsClose CommentsPermalink





‘(D) CONTENTS OF LOGBOOK- The logbook shall contain, at a minimum--CommentsClose CommentsPermalink





‘(i) all of the information required under paragraph (4)(C); andCommentsClose CommentsPermalink





‘(ii) the name, address, and telephone number of the pharmacy to which each prescription was transmitted.CommentsClose CommentsPermalink





‘(E) RULEMAKING AUTHORITY- The Attorney General may promulgate rules relating to the formatting, content, and updating of the logbook required to be kept under clause (A)(i).CommentsClose CommentsPermalink





‘(7) RULE OF CONSTRUCTION- Nothing in this subsection shall be construed to allow an institutional long-term care facility, or an administrator, employee, or agent of an institutional long-term care facility, who is not a practitioner, to prescribe, administer, dispense, distribute, deliver, possess, maintain, stock, or otherwise use a controlled substance except as expressly provided by this title.’.CommentsClose CommentsPermalink

SEC. 4. PRACTITIONER RECORDKEEPING.

Section 307 of the Controlled Substances Act (21 U.S.C. 827) is amended--CommentsClose CommentsPermalink





(1) in subsection (a)--CommentsClose CommentsPermalink





(A) in paragraph (2), by striking ‘and’ at the end;CommentsClose CommentsPermalink





(B) in paragraph (3), by striking ‘inventory.’ and inserting ‘inventory; and’; andCommentsClose CommentsPermalink





(C) by adding at the end the following:CommentsClose CommentsPermalink





‘(4) every registrant who prescribes a controlled substance for a patient residing at an institutional long-term care facility under section 309(f) shall maintain the prescribing log described in subsection (f)(2)(G) of that section.’; andCommentsClose CommentsPermalink





(2) in subsection (c)(1)(A), by adding after ‘treatment of an individual’ the following: ‘, or under section 309(f)’.CommentsClose CommentsPermalink

SEC. 5. PENALTIES.

(a) In General- Section 402 of the Controlled Substances Act (21 U.S.C. 842) is amended--CommentsClose CommentsPermalink





(1) by amending subsection (a)(1) to read as follows:CommentsClose CommentsPermalink





‘(1) who is subject to the requirements of part C, including an institutional long-term care facility and an administrator or employee of an institutional long-term care facility who are subject to any of the requirements under section 309(f), to distribute or dispense a controlled substance, or to aid in the prescribing or dispensing of a controlled substance, in violation of section 309;’; andCommentsClose CommentsPermalink





(2) in subsection (c)--CommentsClose CommentsPermalink





(A) in paragraph (1)--CommentsClose CommentsPermalink





(i) by amending subparagraph (B) to read as follows:CommentsClose CommentsPermalink





‘(B) In the case of a violation of paragraph (5) or (10) of subsection (a) of this section, the civil penalty for each violation shall not exceed $10,000, except that if a person refuses or negligently fails to make any record, report, notification, declaration, or statement required by section 309(f), the civil penalty for each violation shall be not less than $3,000 and not more than $10,000.’; andCommentsClose CommentsPermalink





(ii) by adding at the end the following:CommentsClose CommentsPermalink





‘(C) In the case of a violation of subsection (a)(1), the civil penalty shall be not less than $5,000 for each violation.’; andCommentsClose CommentsPermalink





(B) in paragraph (2)--CommentsClose CommentsPermalink





(i) in subparagraph (A), by striking ‘sentenced to imprisonment of not more than one year’ and inserting ‘sentenced to a term of imprisonment of not more than 3 years’; andCommentsClose CommentsPermalink





(ii) in subparagraph (B), by striking ‘2 years’ and inserting ‘5 years’.CommentsClose CommentsPermalink





(b) Directive to the United States Sentencing Commission-CommentsClose CommentsPermalink





(1) IN GENERAL- Pursuant to its authority under section 994 of title 28, United States Code, and in accordance with this subsection, the United States Sentencing Commission shall review and, if appropriate, amend the Federal Sentencing Guidelines and policy statements to conform to the amendments made by this Act.CommentsClose CommentsPermalink





(2) REQUIREMENTS- In carrying out this subsection, the Commission shall--CommentsClose CommentsPermalink





(A) establish new guidelines and policy statements, as warranted, in order to implement new or revised criminal offenses created under this title;CommentsClose CommentsPermalink





(B) assure reasonable consistency with other relevant directives and with other sentencing guidelines;CommentsClose CommentsPermalink





(C) account for any additional aggravating or mitigating circumstances that might justify exceptions to the generally applicable sentencing ranges;CommentsClose CommentsPermalink





(D) make any necessary conforming changes to the sentencing guidelines; andCommentsClose CommentsPermalink





(E) assure that the guidelines adequately meet the purposes of sentencing under section 3553(a)(2) of title 18, United States Code.CommentsClose CommentsPermalink

SEC. 6. RULE OF CONSTRUCTION.

Nothing in this Act or in the amendments made by this Act shall be construed to alter or eliminate the requirements relating to electronic prescriptions for controlled substances in effect on the date of enactment of this Act, as established by the Attorney General.CommentsClose CommentsPermalink