text: SECTION 1. SHORT TITLE.
  
      This Act may be cited as the ``Compassionate Pain Relief Act''.
  
  SEC. 2. FINDINGS.
  
      Congress finds that--
              (1) cancer is a progressive, degenerative, and often 
          painful disease that afflicts one out of every four persons in 
          the United States and is the second leading cause of death;
              (2) in the progression of terminal cancer, a significant 
          number of patients experience levels of intense and intractable 
          pain that cannot be effectively treated by presently available 
          medication;
              (3) the effect of such pain often leads to a severe 
          deterioration in the quality of life of the patient and 
          heartbreak for the family of the patient;
              (4) the therapeutic use of parenteral diacetylmorphine is 
          not permitted in the United States but extensive clinical 
          research has demonstrated that the drug is a potent, highly 
          soluble painkilling drug when properly formulated and 
          administered under the supervision of a physician;
              (5) it is in the public interest to make parenteral 
          diacetylmorphine available to patients through controlled 
          channels as a drug for the relief of intractable pain due to 
          terminal cancer;
              (6) diacetylmorphine is successfully used in Great Britain 
          and other countries for relief of pain due to cancer;
              (7) the availability of parenteral diacetylmorphine for the 
          limited purposes of controlling intractable pain due to 
          terminal cancer will not adversely affect the abuse of illicit 
          drugs or increase the incidence of pharmacy thefts;
              (8) the availability of parenteral diacetylmorphine will 
          enhance the ability of physicians to effectively treat and 
          control intractable pain due to terminal cancer; and
              (9) it is appropriate for the Federal Government to 
          establish a temporary program to permit the use of 
          pharmaceutical dosage forms of parenteral diacetylmorphine for 
          the control of intractable pain due to terminal cancer.
  
  SEC. 3. PARENTERAL DIACETYLMORPHINE PROGRAM.
  
      Title III of the Public Health Service Act (42 U.S.C. 241 et seq.) 
  is amended by adding at the end the following new part:
  
                    ``Part N--Compassionate Pain Relief
  
  ``SEC. 399G. PARENTERAL DIACETYLMORPHINE.
  
      ``(a) Regulations.--
              ``(1) In general.--Not later than three months after the 
          date of the enactment of this part, the Secretary shall issue 
          regulations establishing a program (referred to in this section 
          as the `program') under which parenteral diacetylmorphine may 
          be dispensed from pharmacies for the relief of intractable pain 
          due to terminal cancer.
              ``(2) Terminal cancer.--For purposes of this section, an 
          individual shall be considered to have terminal cancer if there 
          is histologic evidence of a malignancy in the individual and 
          the cancer of the individual is generally recognized as a 
          cancer with a high and predictable mortality.
      ``(b) Manufacturing.--Regulations established under this section 
  shall provide that manufacturers of parenteral diacetylmorphine for 
  dispensing under the program shall use adequate methods of, and 
  adequate facilities and controls for, the manufacturing, processing, 
  and packing of such drug to preserve the identity, strength, quality, 
  and purity of the drug.
      ``(c) Availability to Pharmacies.--
              ``(1) Requirements.--Regulations established under this 
          section shall require that parenteral diacetylmorphine be made 
          available only to pharmacies that--
                      ``(A) are hospital pharmacies or such other 
                  pharmacies as the regulations specify;
                      ``(B) are registered under section 302 of the 
                  Controlled Substances Act (21 U.S.C. 822);
                      ``(C) meet such qualifications as the regulations 
                  specify; and
                      ``(D) submit an application in accordance with 
                  paragraph (2).
              ``(2) Application.--An application for parenteral 
          diacetylmorphine shall--
                      ``(A) be in such form and submitted in such manner 
                  as the Secretary may prescribe; and
                      ``(B) contain assurances satisfactory to the 
                  Secretary that--
                              ``(i) the applicant will comply with such 
                          special requirements as the Secretary may 
                          prescribe respecting the storage and dispensing 
                          of parenteral diacetylmorphine; and
                              ``(ii) parenteral diacetylmorphine provided 
                          under the application will be dispensed through 
                          the applicant upon the written prescription of 
                          a physician registered under section 302 of the 
                          Controlled Substances Act (21 U.S.C. 822) to 
                          dispense controlled substances in schedule II 
                          of such Act (21 U.S.C. 812(2)).
              ``(3) Intent of congress.--It is the intent of Congress 
          that--
                      ``(A) the Secretary shall primarily utilize 
                  hospital pharmacies for the dispensing of parenteral 
                  diacetylmorphine under the program; and
                      ``(B) the Secretary may distribute parenteral 
                  diacetylmorphine through pharmacies other than hospital 
                  pharmacies in cases in which humanitarian concerns 
                  necessitate the provision of parenteral 
                  diacetylmorphine, a significant need is shown for such 
                  provision, and adequate protection is available against 
                  the diversion of parenteral diacetylmorphine.
      ``(d) Illicit Diversion.--Regulations established by the Secretary 
  under this section shall be designed to protect against the diversion 
  into illicit channels of parenteral diacetylmorphine distributed under 
  the program.
      ``(e) Prescription by Physicians.--Regulations established under 
  this section shall--
              ``(1) require that parenteral diacetylmorphine be dispensed 
          only to an individual in accordance with the written 
          prescription of a physician;
              ``(2) provide that a physician registered under section 302 
          of the Controlled Substances Act (21 U.S.C. 822) may prescribe 
          parenteral diacetylmorphine for individuals for the relief of 
          intractable pain due to terminal cancer;
              ``(3) provide that any such prescription shall be in 
          writing; and
              ``(4) specify such other criteria for the prescription as 
          the Secretary may determine to be appropriate.
      ``(f) Federal Food, Drug, and Cosmetic Act.--The Federal Food, 
  Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) and titles II and III of 
  the Comprehensive Drug Abuse Prevention and Control Act of 1970 (21 
  U.S.C. 801 et seq. and 951 et seq.) shall not apply with respect to--
              ``(1) the importing of opium;
              ``(2) the manufacture of parenteral diacetylmorphine; and
              ``(3) the distribution and dispensing of parenteral 
          diacetylmorphine,
  in accordance with the program.
      ``(g) Reports.--
              ``(1) By the secretary.--
                      ``(A) Implementation and activities.--
                              ``(i) Implementation.--Not later than 2 
                          months after the date of the enactment of this 
                          part and every third month thereafter until the 
                          program is established under subsection (a), 
                          the Secretary shall prepare and submit to the 
                          Committee on Energy and Commerce of the House 
                          of Representatives and the Committee on Labor 
                          and Human Resources of the Senate a report 
                          containing information on the activities 
                          undertaken to implement the program.
                              ``(ii) Activities.--Not later than 1 year 
                          after the date the program is established under 
                          subsection (a) and annually thereafter until 
                          the program is terminated under subsection (h), 
                          the Secretary shall prepare and submit to the 
                          committees described in clause (i) a report 
                          containing information on the activities under 
                          the program during the period for which the 
                          report is submitted.
                      ``(B) Pain management.--Not later than 6 months 
                  after the date of the enactment of this part, the 
                  Secretary shall prepare and submit to the Committee on 
                  Energy and Commerce of the House of Representatives and 
                  the Committee on Labor and Human Resources of the 
                  Senate a report that--
                              ``(i) describes the extent of research 
                          activities on the management of pain that have 
                          received funds through the National Institutes 
                          of Health;
                              ``(ii) describes the ways in which the 
                          Federal Government supports the training of 
                          health personnel in pain management; and
                              ``(iii) contains recommendations for 
                          expanding and improving the training of health 
                          personnel in pain management.
              ``(2) By the comptroller general.--Not later than 56 months 
          after the date on which the program is established under 
          subsection (a), the Comptroller General of the United States 
          shall prepare and submit to the committees referred to in 
          paragraph (1)(A)(i) a report containing information on the 
          activities conducted under the program during such 56-month 
          period.
      ``(h) Termination and Modification.--
              ``(1) In general.--The Secretary may at any time later than 
          6 months after the date on which the program is established 
          under subsection (a), modify the regulations required by 
          subsection (a) or terminate the program if in the judgment of 
          the Secretary the program is no longer needed or if 
          modifications or termination are needed to prevent substantial 
          diversion of the diacetylmorphine.
              ``(2) Final termination.--The program shall terminate 60 
          months after the date the program is established under 
          subsection (a).''.
target: Compassionate Pain Relief Act - Amends the Public Health Service Act to direct the Secretary of Health and Human Services to establish a 60-month program under which parenteral diacetylmorphine may be dispensed from pharmacies for the relief of pain from terminal cancer (as defined by this Act). 
  States that for purposes of such program the Federal Food, Drug, and Cosmetic Act and titles II and III of the Comprehensive Drug Abuse Prevention and Control Act of 1970 shall not apply with respect to: (1) the importing of opium; and (2) the manufacture, distribution, and dispensing of parenteral diacetylmorphine. 
  Requires the Secretary to report to specified congressional committees concerning:  (1) program-related activities; and (2) activities related to the management of pain. 
  Permits the Secretary at any time six months after implementation of the program to modify or terminate the program if:  (1) the program is no longer needed; or (2) modifications or termination are needed to prevent substantial diversion of the diacetylmorphine.
feat_title: Compassionate Pain Relief Act