II 

112TH CONGRESS 

1ST SESSION S. 1560 

To enhance access to controlled substances for residents of institutional longterm care facilities, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

SEPTEMBER 14, 2011 

Mr. KOHL introduced the following bill; which was read twice and referred to 

the Committee on the Judiciary 

A BILL 

To enhance access to controlled substances for residents of 

institutional long-term care facilities, and for other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Nursing Home Resi5 dent Pain Relief Act of 2011’’. 

6 SEC. 2. DEFINITIONS. 

7 Section 102 of the Controlled Substances Act (21 

8 U.S.C. 802) is amended— 


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1 (1) in paragraph (3), by adding at the end the 

2 following: ‘‘Solely for purposes of section 309(f), the 

3 term ‘agent’ includes a facility designee.’’; and 

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

5 ‘‘(57) The term ‘institutional long-term care fa6 cility’ means— 

7 ‘‘(A) a facility certified to participate in 

8 the Medicare or Medicaid programs as a nurs9 ing facility, as defined in section 1919(a) of the 

10 Social Security Act (42 U.S.C. 1396r(a)); 

11 ‘‘(B) a skilled nursing facility, as defined 

12 in section 1819(a) of the Social Security Act 

13 (42 U.S.C. 1395i–3(a)); or 

14 ‘‘(C) any other entity of a type designated 

15 by the Attorney General by regulation. 

16 ‘‘(58) The term ‘administrator of an institu17 tional long-term care facility’ means— 

18 ‘‘(A) a corporation, company, partnership, 

19 or other entity that— 

20 ‘‘(i) owns, operates, or manages an in21 stitutional long-term care facility; and 

22 ‘‘(ii) may be held liable, by law or by 

23 consent, for the acts or omissions of the 

24 facility designees who are delegated au25 thority by the institutional long-term care 


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1 facility in connection with the dispensing 

2 of controlled substances, including liability 

3 for any civil penalties authorized under 

4 part D of this title; and 

5 ‘‘(B) an individual who— 

6 ‘‘(i) has been designated as a co-ad7 ministrator by an entity described in sub8 paragraph (A); 

9 ‘‘(ii) is responsible for managing, su10 pervising, or overseeing the care provided 

11 to residents of the institutional long-term 

12 care facility or the work of the employees 

13 of the institutional long-term care facility; 

14 and 

15 ‘‘(iii) can be held personally liable, 

16 along with the entity described in subpara17 graph (A), at law or by consent, for the 

18 acts or omissions of the facility designees 

19 of the institutional long-term care facility 

20 in connection with the dispensing of con21 trolled substances, including liability for 

22 any civil penalties authorized under section 

23 402.’’. 


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1 SEC. 3. ORAL COMMUNICATION OF PRESCRIPTION INFOR2 MATION FOR RESIDENTS OF INSTITUTIONAL 

3 LONG-TERM CARE FACILITIES. 

4 Section 309 of the Controlled Substances Act (21 

5 U.S.C. 829) is amended— 

6 (1) in subsection (a), in the first sentence, by 

7 inserting ‘‘except as provided in subsection (f) and’’ 

8 after ‘‘without the written prescription of a practi9 tioner’’; and 

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

11 ‘‘(f) CONTROLLED SUBSTANCES DISPENSED TO

12 RESIDENTS OF INSTITUTIONAL LONG-TERM CARE FA13 CILITIES THROUGH THE USE OF FACILITY DESIGNEES.— 

14 ‘‘(1) DEFINITIONS.—In this subsection— 

15 ‘‘(A) the term ‘authorizing agreement’ 

16 means a written agreement— 

17 ‘‘(i) between— 

18 ‘‘(I) an individual practitioner 

19 providing medical care to, or super20 vising medical care being provided to, 

21 a resident of an institutional long22 term care facility whose care is pro23 vided or supervised by the practi24 tioner; and 

25 ‘‘(II) an administrator of the in26 stitutional long-term care facility; 


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1 ‘‘(ii) that authorizes the administrator 

2 to designate 1 or more qualified individuals 

3 to act as facility designees for the purpose 

4 of dispensing a controlled substance to the 

5 resident; and 

6 ‘‘(iii) that includes a written author7 ization from the practitioner, in a form 

8 and manner specified by the Attorney Gen9 eral, that specifies whether the scope of the 

10 authorization is for— 

11 ‘‘(I) controlled substances in 

12 schedule II only; or 

13 ‘‘(II) all controlled substances, 

14 regardless of schedule; and 

15 ‘‘(B) the term ‘facility designee’ means an 

16 individual designated by the administrator to 

17 whom the authority to act as an agent of a 

18 practitioner is delegated under paragraph 

19 (3)(A). 

20 ‘‘(2) AUTHORIZATION.— 

21 ‘‘(A) IN GENERAL.—A practitioner may 

22 enter into an authorizing agreement with an ad23 ministrator of an institutional long-term care 

24 facility if the administrator has— 


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1 ‘‘(i) adopted written policies and pro2 cedures that specify the duties and respon3 sibilities of a facility designee and that re4 quire documentation of the acceptance of 

5 the duties and responsibilities by a facility 

6 designee, consistent with the authorizing 

7 agreement; and 

8 ‘‘(ii) provided copies of the policies 

9 and procedures adopted under clause (i) to 

10 the practitioner and to each facility des11 ignee. 

12 ‘‘(B) RESCISSION OF AUTHORITY.—A 

13 practitioner may in writing, at any time— 

14 ‘‘(i) rescind the authorizing agree15 ment; 

16 ‘‘(ii) rescind the authority of a facility 

17 designee; or 

18 ‘‘(iii) modify the scope of the author19 ization of a facility designee. 

20 ‘‘(3) DELEGATION OF AUTHORITY.— 

21 ‘‘(A) IN GENERAL.—Under an authorizing 

22 agreement, an administrator of an institutional 

23 long-term care facility may, in accordance with 

24 the policies and procedures described in para25 graph (2)(A)(i) delegate, in writing, the authorVerDate Mar 15 2010 01:44 Sep 16, 2011 Jkt 099200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S1560.IS S1560

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1 ity to act as a facility designee to 1 or more 

2 health care professionals who are qualified 

3 under subparagraph (B). 

4 ‘‘(B) REQUIREMENTS FOR QUALIFICA5 TION.—To qualify to be a facility designee 

6 under subparagraph (A), a health care profes7 sional shall be— 

8 ‘‘(i) directly employed by, and subject 

9 to the supervision and control of, the insti10 tutional long-term care facility; 

11 ‘‘(ii) lawfully acting within the scope 

12 of the employment of the individual; and 

13 ‘‘(iii) be a registered nurse, advanced 

14 practice nurse, physician’s assistant, or 

15 equivalent professional who is licensed, cer16 tified, registered, or otherwise permitted to 

17 provide professional nursing or health care 

18 by the jurisdiction in which the individual 

19 is employed. 

20 ‘‘(C) REQUIREMENT.—A written delega21 tion of authority under subparagraph (A) shall 

22 specify, at the option of the practitioner, and in 

23 accordance with the authorizing agreement, 

24 whether the scope of the authorization is for— 


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1 ‘‘(i) schedule II controlled substances 

2 only; or 

3 ‘‘(ii) all controlled substances, regard4 less of schedule. 

5 ‘‘(D) SERVICE AS A FACILITY DESIGNEE.— 

6 A facility designee shall act in accordance with 

7 the policies and procedures described in para8 graph (2)(A)(i). 

9 ‘‘(E) LIST OF AUTHORIZING AGREEMENTS

10 AND FACILITY DESIGNEES.— 

11 ‘‘(i) IN GENERAL.—An administrator 

12 of an institutional long-term care facility 

13 shall establish and maintain a current list 

14 of— 

15 ‘‘(I) all practitioners who have 

16 entered into an authorizing agreement 

17 with the administrator; and 

18 ‘‘(II) all facility designees of each 

19 practitioner described in subclause (I) 

20 that are employees of the institutional 

21 long-term care facility. 

22 ‘‘(ii) REQUIREMENTS.—The list re23 quired under clause (i) shall— 

24 ‘‘(I) be— 


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1 ‘‘(aa) dated upon establish2 ment and each time the list is 

3 updated; and 

4 ‘‘(bb) made readily available 

5 in appropriate places on the 

6 premises of the institutional long7 term care facility to ensure prop8 er notice of which employees of 

9 the institutional long-term care 

10 facility are facility designees for 

11 which practitioners; and 

12 ‘‘(II) include— 

13 ‘‘(aa) the name and address 

14 of the institutional long-term 

15 care facility and the adminis16 trator of the institutional long17 term care facility; 

18 ‘‘(bb) the name of each 

19 practitioner who has entered into 

20 an authorizing agreement with 

21 the administrator of the institu22 tional long-term care facility; and 

23 ‘‘(cc) for each practitioner 

24 listed under item (bb)— 


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1 ‘‘(AA) the name of each 

2 facility designee; and 

3 ‘‘(BB) whether practi4 tioner is providing author5 ization for schedule II con6 trolled substances only or all 

7 controlled substances, re8 gardless of schedule. 

9 ‘‘(iii) DISTRIBUTION OF LIST.—An 

10 administrator of an institutional long-term 

11 care facility shall provide the list estab12 lished under clause (i) to— 

13 ‘‘(I) all pharmacies to which the 

14 institutional long-term care facility 

15 submits prescriptions for dispensing; 

16 and 

17 ‘‘(II) each practitioner who has 

18 entered into an authorizing agreement 

19 with the administrator of the institu20 tional long-term care facility. 

21 ‘‘(iv) UPDATES.—The administrator 

22 of an institutional long-term care facility 

23 shall promptly update and redistribute a 

24 list established under clause (i) if— 


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1 ‘‘(I) there are any changes to the 

2 information required to be included in 

3 the list under clause (ii); or 

4 ‘‘(II) the authority of any facility 

5 designee on the list is rescinded or 

6 modified under paragraph (2)(B). 

7 ‘‘(F) PROHIBITION OF REDELEGATION OF

8 AUTHORITY.—A facility designee may not re9 delegate any aspect of the authorization of the 

10 practitioner to another individual. 

11 ‘‘(4) TRANSMISSION BY A FACILITY DESIGNEE

12 OF A VALID ORAL PRESCRIPTION ISSUED BY PRACTI13 TIONER.— 

14 ‘‘(A) IN GENERAL.—Except as provided in 

15 subparagraph (D), a practitioner who is pro16 viding medical care to, or supervising medical 

17 care being provided to, a resident of an institu18 tional long-term care facility may issue an oral 

19 prescription for the resident for a controlled 

20 substance which is a prescription drug as deter21 mined under the Federal Food, Drug, and Cos22 metic Act (21 U.S.C. 301 et seq.), and the oral 

23 prescription may be communicated through a 

24 facility designee acting under the authorizing 

25 agreement of the practitioner. 


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1 ‘‘(B) POLICIES.—A practitioner or a facil2 ity designee acting under this subsection shall 

3 follow the requirements of this subsection re4 gardless of the schedule of the controlled sub5 stance for which an oral prescription is being 

6 communicated. 

7 ‘‘(C) REQUIREMENTS.— 

8 ‘‘(i) RESPONSIBILITIES OF PRACTI9 TIONER.—In issuing an oral prescription 

10 under subparagraph (A), a practitioner 

11 shall provide to the facility designee— 

12 ‘‘(I) the full name of the resi13 dent; 

14 ‘‘(II) the drug name, strength, 

15 and dosage form; 

16 ‘‘(III) the quantity prescribed; 

17 ‘‘(IV) the directions for use; and 

18 ‘‘(V) the name, address, and 

19 Drug Enforcement Administration 

20 registration number of the prescribing 

21 practitioner. 

22 ‘‘(ii) RESPONSIBILITIES OF A FACIL23 ITY DESIGNEE.—A facility designee that 

24 receives an oral prescription issued under 

25 subparagraph (A) shall promptly— 


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1 ‘‘(I) create a document that re2 duces such oral prescription to writ3 ing, which shall include— 

4 ‘‘(aa) all of the information 

5 provided by the practitioner 

6 under clause (i); 

7 ‘‘(bb) the legible full name 

8 and signature of the facility des9 ignee; 

10 ‘‘(cc) the name and address 

11 of the institutional long-term 

12 care facility; 

13 ‘‘(dd) the date and time the 

14 facility designee received the oral 

15 prescription; and 

16 ‘‘(ee) an attestation by the 

17 covered individual, under penalty 

18 of perjury as provided in section 

19 1746 of title 28, United States 

20 Code, that— 

21 ‘‘(AA) the facility des22 ignee has personally spoken 

23 with the prescribing practi24 tioner; and 


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1 ‘‘(BB) all the informa2 tion required under clause 

3 (i) was provided by the prac4 titioner and is accurately 

5 and completely recorded by 

6 the facility designee on the 

7 document; and 

8 ‘‘(II) transmit the written docu9 ment, or a facsimile thereof, to a 

10 pharmacy for dispensing. 

11 ‘‘(iii) PROHIBITION.—A document de12 scribed in clause (ii)(I) may not be pre13 pared, in whole or in part, by a pharmacy. 

14 ‘‘(iv) FACSIMILES.—If a facility des15 ignee transmits a written document de16 scribed in clause (ii)(I) by facsimile, the 

17 facsimile shall serve as the original written 

18 prescription and shall be maintained in ac19 cordance with regulations promulgated by 

20 the Attorney General. 

21 ‘‘(D) SCHEDULE II CONTROLLED SUB22 STANCES.— 

23 ‘‘(i) IN GENERAL.—An oral prescrip24 tion for a schedule II controlled substance 

25 shall only be issued through or transmitted 


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1 by a facility designee under subparagraph 

2 (A) during an emergency situation, as de3 scribed in subsection (a), and the quantity 

4 prescribed shall be limited to an amount 

5 adequate to treat the patient during the 

6 emergency situation. 

7 ‘‘(ii) NON-EMERGENCY SITUATIONS.— 

8 A schedule II controlled substance may 

9 only be dispensed for treatment of a resi10 dent of an institutional long-term care fa11 cility in a non-emergency situation if the 

12 prescription is in writing and signed by the 

13 prescribing individual practitioner, as de14 scribed in subsection (a). 

15 ‘‘(E) RULE OF CONSTRUCTION.—Nothing 

16 in this subsection shall be construed to— 

17 ‘‘(i) preclude a practitioner from 

18 issuing— 

19 ‘‘(I) a prescription for a con20 trolled substance and transmitting the 

21 prescription directly to the pharmacy, 

22 as otherwise authorized in subsections 

23 (a), (b), or (c) or by regulations 

24 issued by the Attorney General; or 


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1 ‘‘(II) a written prescription for a 

2 controlled substance, signed by the 

3 practitioner, and having the written 

4 prescription transmitted to the phar5 macy through a duly authorized agent 

6 of the practitioner (including a facility 

7 designee), as otherwise authorized by 

8 subsections (a), (b), or (c) of this sec9 tion or by regulations issued by the 

10 Attorney General; or 

11 ‘‘(ii) authorize a facility designee to 

12 make any determination that underlies any 

13 element of a prescription. 

14 ‘‘(F) RULEMAKING AUTHORITY.—The At15 torney General may, by regulation, promulgate 

16 rules specifying additional requirements with 

17 respect to the formatting, content, and creation 

18 of the written document described in subpara19 graph (C)(ii). 

20 ‘‘(G) RECORD OF ORAL PRESCRIPTIONS.— 

21 ‘‘(i) IN GENERAL.—Each practitioner 

22 who issues an oral prescription to a facility 

23 designee shall— 

24 ‘‘(I) create a contemporaneous 

25 record of the oral prescription; and 


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1 ‘‘(II) maintain the record in a 

2 written or electronic log at the reg3 istered location of the practitioner, in 

4 accordance with section 307. 

5 ‘‘(ii) CONTENTS AND RETENTION RE6 QUIREMENTS.—The Attorney General shall 

7 specify by regulation the contents and re8 tention requirements for record required to 

9 be kept under clause (i). 

10 ‘‘(iii) RESPONSIBILITY OF THE PRAC11 TITIONER.—A practitioner shall be respon12 sible for the creation of the contempora13 neous record of the oral prescription re14 quired under clause (i)(I), and may not 

15 delegate or assign any responsibilities 

16 under clause (i), in whole or in part, to— 

17 ‘‘(I) a pharmacy; 

18 ‘‘(II) a facility designee; or 

19 ‘‘(III) an institutional long-term 

20 care facility (including an employee of 

21 the institutional long-term care facil22 ity). 

23 ‘‘(H) DEFINITION OF ORAL PRESCRIP24 TION.—The Attorney General may, if deter25 mined by the Attorney General to be necessary, 


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1 define by regulation the term ‘oral prescription’ 

2 for purposes of this subsection. 

3 ‘‘(5) PHARMACY VERIFICATION OF ORAL PRE4 SCRIPTIONS TRANSMITTED BY FACILITY DES5 IGNEES.— 

6 ‘‘(A) IN GENERAL.—Upon receiving an 

7 oral prescription from a practitioner that was 

8 reduced to writing and transmitted under para9 graph (4), a pharmacy shall— 

10 ‘‘(i) determine whether the institu11 tional long-term care facility employee who 

12 transmitted the prescription is a facility 

13 designee for the prescribing practitioner 

14 for the prescribed controlled substance 

15 based on the most recent list of the facility 

16 designees that the institutional long-term 

17 care facility provided to the pharmacy 

18 under paragraph (3)(E)(iii); and 

19 ‘‘(ii) document the determination 

20 under clause (i), which shall include a no21 tation on the prescription document to me22 morialize that the cross-check was com23 pleted that includes— 

24 ‘‘(I) the initials of the verifying 

25 pharmacist; and 


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1 ‘‘(II) the date and time of the 

2 verification. 

3 ‘‘(B) TRANSMISSION TO PRESCRIBING

4 PRACTITIONER.—Not later than 72 hours after 

5 a pharmacy dispenses a controlled substance 

6 pursuant to an oral prescription issued under 

7 paragraph (4), the pharmacy shall transmit a 

8 copy of the prescription document that the 

9 pharmacy received from the facility designee 

10 under paragraph (4)(C)(ii), clearly marked as 

11 having been dispensed, to the prescribing prac12 titioner. 

13 ‘‘(C) PRACTITIONER REQUIREMENT.—A 

14 practitioner shall— 

15 ‘‘(i) endorse, by physically affixing his 

16 written signature to the copy of the pre17 scription the pharmacy transmitted to the 

18 practitioner under subparagraph (B), if 

19 the prescription was issued by the practi20 tioner; and 

21 ‘‘(ii) not later than 5 business days 

22 after receiving the copy of the prescription 

23 from the pharmacy, return the prescription 

24 to the pharmacy in accordance with sub25 paragraph (E). 


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1 ‘‘(D) ENDORSEMENT OF PRESCRIPTION.— 

2 By endorsing a prescription under subpara3 graph (C), the practitioner— 

4 ‘‘(i) attests that the oral prescription 

5 memorialized and transmitted by a facility 

6 designee was authorized by the practitioner 

7 named on the prescription; and 

8 ‘‘(ii) certifies that the prescription in9 formation conveyed by the facility des10 ignee— 

11 ‘‘(I) was accurate; 

12 ‘‘(II) matches the information in 

13 the record kept by the practitioner 

14 under paragraph (4)(G); and 

15 ‘‘(III) was based on determina16 tions and instructions made by the 

17 practitioner. 

18 ‘‘(E) RETURN OF ENDORSED PRESCRIP19 TION TO PHARMACY.—The practitioner may de20 liver a prescription endorsed under subpara21 graph (C)(i) to the pharmacy in person, by 

22 mail, by facsimile, or by other appropriate 

23 means of delivery, except that if the practitioner 

24 uses the mail for delivery, the prescription shall 


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1 be postmarked during the 5-business-day period 

2 described in subparagraph (C)(ii). 

3 ‘‘(F) ATTACHMENT OF ENDORSEMENT TO

4 PRESCRIPTION.—A dispensing pharmacy shall 

5 attach a prescription endorsed under subpara6 graph (C)(i) to the prescription document that 

7 the pharmacy received from the facility designee 

8 under paragraph (4)(C). 

9 ‘‘(G) NONCOMPLIANCE.— 

10 ‘‘(i) IN GENERAL.—If a pharmacy 

11 does not receive an endorsed prescription 

12 required under this paragraph from a 

13 practitioner within the 5-business-day pe14 riod described in subparagraph (C)(ii), the 

15 pharmacy— 

16 ‘‘(I) may not dispense any subse17 quent prescriptions for controlled sub18 stances issued by or on behalf of the 

19 practitioner for residents at the insti20 tutional long-term care facility, unless 

21 the prescription is a written prescrip22 tion issued directly by the practi23 tioner, until the required endorsement 

24 of the oral prescription is received; 

25 and 


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1 ‘‘(II) shall note the limitation de2 scribed in subclause (I) on the most 

3 recent copy of the list that the institu4 tional long-term care facility provided 

5 to the pharmacy under paragraph 

6 (3)(E)(iii). 

7 ‘‘(ii) NOTICE TO DEA.—A pharmacy 

8 shall notify the nearest office of the Drug 

9 Enforcement Administration if the phar10 macy does not receive an endorsed pre11 scription from a practitioner by the end of 

12 the 10-business-day period beginning on 

13 the date on which the pharmacy trans14 mitted notice to the practitioner under 

15 subparagraph (B). 

16 ‘‘(6) RECORDKEEPING.— 

17 ‘‘(A) IN GENERAL.—Each institutional 

18 long-term care facility shall— 

19 ‘‘(i) maintain a readily retrievable 

20 written or electronic logbook, in which it 

21 records each instance in which a facility 

22 designee memorializes and transmits an 

23 oral prescription for a controlled substance 

24 to a pharmacy on behalf of a practitioner 

25 under paragraph (4); and 


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1 ‘‘(ii) keep, on the premises of the in2 stitutional long-term care facility— 

3 ‘‘(I) the logbook described in 

4 clause (i); and 

5 ‘‘(II) copies of— 

6 ‘‘(aa) any authorizing agree7 ments; 

8 ‘‘(bb) any policies and proce9 dures issued by the institutional 

10 long-term care facility under 

11 paragraph (2)(A)(i); 

12 ‘‘(cc) any notice of rescission 

13 or modification of the authority 

14 of a facility designee; 

15 ‘‘(dd) each list prepared by 

16 the administrator of the institu17 tional long-term care facility 

18 under paragraph (3)(E); and 

19 ‘‘(ee) all documents created 

20 by facility designees to reduce 

21 oral prescriptions to writing, 

22 under paragraph (4)(C)(ii)(I). 

23 ‘‘(B) RETENTION OF COPIES.—An institu24 tional long-term care facility shall— 


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1 ‘‘(i) retain a copy of any document de2 scribed in subparagraph (A)(ii)(II) until 

3 the end of the 5-year period beginning on 

4 the date on which the document was cre5 ated; and 

6 ‘‘(ii) whether retained in written or 

7 electronic form, make available for inspec8 tion and copying by the Attorney General 

9 under section 510— 

10 ‘‘(I) the logbook described in sub11 paragraph (A)(i); and 

12 ‘‘(II) copies of the documents de13 scribed in subparagraph (A)(ii)(II). 

14 ‘‘(C) PROHIBITION.—The logbook required 

15 under subparagraph (A)(i) may not be pre16 pared, maintained, or updated, in whole or in 

17 part, by a pharmacy. 

18 ‘‘(D) CONTENTS OF LOGBOOK.—The log19 book shall contain, at a minimum— 

20 ‘‘(i) all of the information required 

21 under paragraph (4)(C); and 

22 ‘‘(ii) the name, address, and telephone 

23 number of the pharmacy to which each 

24 prescription was transmitted. 


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1 ‘‘(E) RULEMAKING AUTHORITY.—The At2 torney General may promulgate rules relating 

3 to the formatting, content, and updating of the 

4 logbook required to be kept under clause (A)(i). 

5 ‘‘(7) RULE OF CONSTRUCTION.—Nothing in 

6 this subsection shall be construed to allow an insti7 tutional long-term care facility, or an administrator, 

8 employee, or agent of an institutional long-term care 

9 facility, who is not a practitioner, to prescribe, ad10 minister, dispense, distribute, deliver, possess, main11 tain, stock, or otherwise use a controlled substance 

12 except as expressly provided by this title.’’. 

13 SEC. 4. PRACTITIONER RECORDKEEPING. 

14 Section 307 of the Controlled Substances Act (21 

15 U.S.C. 827) is amended— 

16 (1) in subsection (a)— 

17 (A) in paragraph (2), by striking ‘‘and’’ at 

18 the end; 

19 (B) in paragraph (3), by striking ‘‘inven20 tory.’’ and inserting ‘‘inventory; and’’; and 

21 (C) by adding at the end the following: 

22 ‘‘(4) every registrant who prescribes a con23 trolled substance for a patient residing at an institu24 tional long-term care facility under section 309(f) 


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1 shall maintain the prescribing log described in sub2 section (f)(2)(G) of that section.’’; and 

3 (2) in subsection (c)(1)(A), by adding after 

4 ‘‘treatment of an individual’’ the following: ‘‘, or 

5 under section 309(f)’’. 

6 SEC. 5. PENALTIES. 

7 (a) IN GENERAL.—Section 402 of the Controlled 

8 Substances Act (21 U.S.C. 842) is amended— 

9 (1) by amending subsection (a)(1) to read as 

10 follows: 

11 ‘‘(1) who is subject to the requirements of part 

12 C, including an institutional long-term care facility 

13 and an administrator or employee of an institutional 

14 long-term care facility who are subject to any of the 

15 requirements under section 309(f), to distribute or 

16 dispense a controlled substance, or to aid in the pre17 scribing or dispensing of a controlled substance, in 

18 violation of section 309;’’; and 

19 (2) in subsection (c)— 

20 (A) in paragraph (1)— 

21 (i) by amending subparagraph (B) to 

22 read as follows: 

23 ‘‘(B) In the case of a violation of para24 graph (5) or (10) of subsection (a) of this sec25 tion, the civil penalty for each violation shall 


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1 not exceed $10,000, except that if a person re2 fuses or negligently fails to make any record, 

3 report, notification, declaration, or statement 

4 required by section 309(f), the civil penalty for 

5 each violation shall be not less than $3,000 and 

6 not more than $10,000.’’; and 

7 (ii) by adding at the end the fol8 lowing: 

9 ‘‘(C) In the case of a violation of sub10 section (a)(1), the civil penalty shall be not less 

11 than $5,000 for each violation.’’; and 

12 (B) in paragraph (2)— 

13 (i) in subparagraph (A), by striking 

14 ‘‘sentenced to imprisonment of not more 

15 than one year’’ and inserting ‘‘sentenced to 

16 a term of imprisonment of not more than 

17 3 years’’; and 

18 (ii) in subparagraph (B), by striking 

19 ‘‘2 years’’ and inserting ‘‘5 years’’. 

20 (b) DIRECTIVE TO THE UNITED STATES SEN21 TENCING COMMISSION.— 

22 (1) IN GENERAL.—Pursuant to its authority 

23 under section 994 of title 28, United States Code, 

24 and in accordance with this subsection, the United 

25 States Sentencing Commission shall review and, if 


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1 appropriate, amend the Federal Sentencing Guide2 lines and policy statements to conform to the 

3 amendments made by this Act. 

4 (2) REQUIREMENTS.—In carrying out this sub5 section, the Commission shall— 

6 (A) establish new guidelines and policy 

7 statements, as warranted, in order to imple8 ment new or revised criminal offenses created 

9 under this title; 

10 (B) assure reasonable consistency with 

11 other relevant directives and with other sen12 tencing guidelines; 

13 (C) account for any additional aggravating 

14 or mitigating circumstances that might justify 

15 exceptions to the generally applicable sentencing 

16 ranges; 

17 (D) make any necessary conforming 

18 changes to the sentencing guidelines; and 

19 (E) assure that the guidelines adequately 

20 meet the purposes of sentencing under section 

21 3553(a)(2) of title 18, United States Code. 

22 SEC. 6. RULE OF CONSTRUCTION. 

23 Nothing in this Act or in the amendments made by 

24 this Act shall be construed to alter or eliminate the re25 quirements relating to electronic prescriptions for conVerDate Mar 15 2010 01:44 Sep 16, 2011 Jkt 099200 PO 00000 Frm 00028 Fmt 6652 Sfmt 6201 E:\BILLS\S1560.IS S1560

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1 trolled substances in effect on the date of enactment of 

2 this Act, as established by the Attorney General. 

Æ 


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