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38 U.S.C. § 7414 — Compliance with requirements for examining qualifications and clinical abilities of health care professionals

Federal law — U.S. Code and appendices · legal_authorities

38 U.S.C. § 7414 — Compliance with requirements for examining qualifications and clinical abilities of health care professionals

**(a) Compliance With Credentialing Requirements.—** The Secretary shall ensure that each medical center of the Department, in a consistent manner— (1) compiles, verifies, and reviews documentation for each health care professional of the Department at such medical center regarding, at a minimum— (A) the professional licensure, certification, or registration of the health care professional; (B) whether the health care professional holds a Drug Enforcement Administration registration; and (C) the education, training, experience, malpractice history, and clinical competence of the health care professional; and (2) continuously monitors any changes to the matters under paragraph (1), including with respect to suspensions, restrictions, limitations, probations, denials, revocations, and other changes, relating to the failure of a health care professional to meet generally accepted standards of clinical practice in a manner that presents reasonable concern for the safety of patients. **(b) Registration Regarding Controlled Substances.—** (1) Except as provided in paragraph (2), the Secretary shall ensure that each covered health care professional holds an active Drug Enforcement Administration registration. (2) The Secretary shall— (A) determine the circumstances in which a medical center of the Department must obtain a waiver under section 302(d) of the Controlled Substances Act ([21 U.S.C. 822(d)](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section822/d&num=0&edition=prelim)) with respect to covered health care professionals; and (B) establish a process for medical centers to request such waivers. (3) In carrying out paragraph (1), the Secretary shall ensure that each medical center of the Department monitors the Drug Enforceme

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Source location: Title 38, Chapter 74, § 7414; chapter-074-veterans-health-administration-personnel.md

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**(a) Compliance With Credentialing Requirements.—** The Secretary shall ensure that each medical center of the Department, in a consistent manner— (1) compiles, verifies, and reviews documentation for each health care professional of the Department at such medical center regarding, at a minimum— (A) the professional licensure, certification, or registration of the health care professional; (B) whether the health care professional holds a Drug Enforcement Administration registration; and (C) the education, training, experience, malpractice history, and clinical competence of the health care professional; and (2) continuously monitors any changes to the matters under paragraph (1), including with respect to suspensions, restrictions, limitations, probations, denials, revocations, and other changes, relating to the failure of a health care professional to meet generally accepted standards of clinical practice in a manner that presents reasonable concern for the safety of patients. **(b) Registration Regarding Controlled Substances.—** (1) Except as provided in paragraph (2), the Secretary shall ensure that each covered health care professional holds an active Drug Enforcement Administration registration. (2) The Secretary shall— (A) determine the circumstances in which a medical center of the Department must obtain a waiver under section 302(d) of the Controlled Substances Act ([21 U.S.C. 822(d)](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section822/d&num=0&edition=prelim)) with respect to covered health care professionals; and (B) establish a process for medical centers to request such waivers. (3) In carrying out paragraph (1), the Secretary shall ensure that each medical center of the Department monitors the Drug Enforcement Administration registrations of covered health care professionals at such medical center in a manner that ensures the medical center is made aware of any change in status in the registration by not later than seven days after such change in status. (4) If a covered health care professional does not hold an active Drug Enforcement Administration registration, the Secretary shall carry out any of the following actions, as the Secretary determines appropriate: (A) Obtain a waiver pursuant to paragraph (2). (B) Transfer the health care professional to a position that does not require prescribing, dispensing, administering, or conducting research with controlled substances. (C) Take appropriate actions under subchapter V of this chapter, with respect to an employee of the Department, or take appropriate contract administration actions, with respect to a contractor of the Department. **(c) Reviews of Concerns Relating to Quality of Clinical Care.—** (1) The Secretary shall ensure that each medical center of the Department, in a consistent manner, carries out— (A) ongoing, retrospective, and comprehensive monitoring of the performance and quality of the health care delivered by each health care professional of the Department located at the medical center, including with respect to the safety of such care; and (B) timely and documented reviews of such care if an individual notifies the Secretary of any potential concerns relating to a failure of a health care professional of the Department to meet generally accepted standards of clinical practice in a manner that presents reasonable concern for the safety of patients. (2) The Secretary shall establish a policy to carry out paragraph (1), including with respect to— (A) determining the period by which a medical center of the Department must initiate the review of a concern described in subparagraph (B) of such paragraph following the date on which the concern is received; and (B) ensuring the compliance of each medical center with such policy. **(d) Compliance With Requirements for Reporting Quality of Care Concerns.—** If the Secretary substantiates a concern relating to the clinical competency of, or quality of care delivered by, a health care professional of the Department (including a former health care professional of the Department), the Secretary shall ensure that the appropriate medical center of the Department timely notifies the following entities of such concern, as appropriate: (1) The appropriate licensing, registration, or certification body in each State in which the health care professional is licensed, registered, or certified. (2) The Drug Enforcement Administration. (3) The National Practitioner Data Bank established pursuant to the Health Care Quality Improvement Act of 1986 ([42 U.S.C. 11101](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section11101&num=0&edition=prelim) et seq.). (4) Any other relevant entity. **(e) Prohibition on Certain Settlement Agreement Terms.—** (1) The Secretary may not enter into a settlement agreement relating to an adverse action against a health care professional of the Department if such agreement includes terms that require the Secretary to conceal from the personnel file of the employee a serious medical error or lapse in clinical practice that constitutes a substantial failure to meet generally accepted standards of clinical practice as to raise reasonable concern for the safety of patients. (2) Nothing in paragraph (1) limits— (A) the right of an employee to appeal a quality of care determination; or (B) the rights of an employee under sections 1214 and 1221 of title 5. **(f) Training.—** Not less frequently than annually, the Secretary shall provide mandatory training on the following duties to employees of the Department who are responsible for performing such duties: (1) Compiling, validating, or reviewing the credentials of health care professionals of the Department. (2) Reviewing the quality of clinical care delivered by health care professionals of the Department. (3) Taking adverse privileging actions or making determinations relating to other disciplinary actions or employment actions against health care professionals of the Department for reasons relating to the failure of a health care professional to meet generally accepted standards of clinical practice in a manner that presents reasonable concern for the safety of patients. (4) Making notifications under subsection (d). **(g) Definitions.—** In this section: (1) The term “controlled substance” has the meaning given that term in section 102 of the Controlled Substances Act ([21 U.S.C. 802](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section802&num=0&edition=prelim)). (2) The term “covered health care professional” means an individual employed in a position as a health care professional of the Department, or a contractor of the Department, that requires the individual to be authorized to prescribe, dispense, administer, or conduct research with, controlled substances. (3) The term “Drug Enforcement Administration registration” means registration with the Drug Enforcement Administration under section 303 of the Controlled Substances Act ([21 U.S.C. 823](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section823&num=0&edition=prelim)) 302 of the Controlled Substances Act ([21 U.S.C. 822](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section822&num=0&edition=prelim)) by health care practitioners authorized to dispense, prescribe, administer, or conduct research with, controlled substances. (4) The term “health care professional of the Department” means an individual working for the Department in a position described in [section 7401 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title38-section7401&num=0&edition=prelim), including a contractor of the Department serving in such a position.

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 822 — Persons required to register

**(a) Period of registration** (1) Every person who manufactures or distributes any controlled substance or list I chemical, or who proposes to engage in the manufacture or distribution of any controlled substance or list I chemical, shall obtain annually a registration issued by the Attorney General in accordance with the rules and regulations promulgated by him. (2) Every person who dispenses, or who proposes to dispense, any controlled substance, shall obtain from the Attorney General a registration issued in accordance with the rules and regulations promulgated by him. The Attorney General shall, by regulation, determine the period of such registrations. In no event, however, shall such registrations be issued for less than one year nor for more than three years. (3) (A) Except as provided in subparagraph (C), the registration of any registrant under this subchapter to manufacture, distribute, or dispense controlled substances or list I chemicals terminates if and when such registrant— (i) dies; (ii) ceases legal existence; (iii) discontinues business or professional practice; or (iv) surrenders such registration. (B) In the case of such a registrant who ceases legal existence or discontinues business or professional practice, such registrant shall promptly notify the Attorney General in writing of such fact. (C) No registration under this subchapter to manufacture, distribute, or dispense controlled substances or list I chemicals, and no authority conferred thereby, may be assigned or otherwise transferred except upon such conditions as the Attorney General may specify and then only pursuant to written consent. A registrant to whom a registration is assigned or transferred pursuant to the preceding sentence may not manufacture, distr

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Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 11101 — Reports and memoranda of understanding

**(a) Annual reports to Congress** The Secretary shall report to Congress, annually during the three years after November 14, 1986, on the implementation of this chapter. **(b) Memoranda of understanding** The Secretary of Health and Human Services shall seek to enter into memoranda of understanding with the Secretary of Defense and the Administrator of Veterans’ Affairs to apply the provisions of subchapter II of this chapter to hospitals and other facilities and health care providers under the jurisdiction of the Secretary or Administrator, respectively. The Secretary shall report to Congress, not later than two years after November 14, 1986, on any such memoranda and on the cooperation among such officials in establishing such memoranda. **(c) Memorandum of understanding with Drug Enforcement Administration** The Secretary of Health and Human Services shall seek to enter into a memorandum of understanding with the Administrator of Drug Enforcement relating to providing for the reporting by the Administrator to the Secretary of information respecting physicians and other practitioners whose registration to dispense controlled substances has been suspended or revoked under [section 824 of title 21](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section824&num=0&edition=prelim). The Secretary shall report to Congress, not later than two years after November 14, 1986, on any such memorandum and on the cooperation between the Secretary and the Administrator in establishing such a memorandum.

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Federal law — U.S. Code and appendices · legal_authorities

38 U.S.C. § 7401 — Appointments in Veterans Health Administration

There may be appointed by the Secretary such personnel as the Secretary may find necessary for the health care of veterans (in addition to those in the Office of the Under Secretary for Health appointed under [section 7306 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title38-section7306&num=0&edition=prelim)), as follows: (1) Physicians, dentists, podiatrists, chiropractors, optometrists, registered nurses, physician assistants, and expanded-function dental auxiliaries. (2) Scientific and professional personnel, such as microbiologists, chemists, and biostatisticians. (3) Audiologists, licensed hearing aid specialists, speech pathologists, and audiologist-speech pathologists, biomedical engineers, certified or registered respiratory therapists, dietitians, licensed physical therapists, licensed practical or vocational nurses, nurse assistants, medical instrument technicians, medical records administrators or specialists, medical records technicians, medical technologists, dental hygienists, dental assistants, nuclear medicine technologists, occupational therapists, occupational therapy assistants, kinesiotherapists, orthotist-prosthetists, pharmacists, pharmacy technicians, physical therapy assistants, prosthetic representatives, psychologists, diagnostic radiologic technologists, therapeutic radiologic technologists, social workers, marriage and family therapists, licensed professional mental health counselors, blind rehabilitation specialists, blind rehabilitation outpatient specialists, statisticians, economists, informaticists, data scientists, and and 11 So in original. such other classes of health care occupations as the Secretary considers necessary for the recruitment and retention needs of the Department subject to the followin

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 823 — Registration requirements

**(a) Manufacturers of controlled substances in schedule I or II** The Attorney General shall register an applicant to manufacture controlled substances in schedule I or II if he determines that such registration is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. In determining the public interest, the following factors shall be considered: (1) maintenance of effective controls against diversion of particular controlled substances and any controlled substance in schedule I or II compounded therefrom into other than legitimate medical, scientific, research, or industrial channels, by limiting the importation and bulk manufacture of such controlled substances to a number of establishments which can produce an adequate and uninterrupted supply of these substances under adequately competitive conditions for legitimate medical, scientific, research, and industrial purposes; (2) compliance with applicable State and local law; (3) promotion of technical advances in the art of manufacturing these substances and the development of new substances; (4) prior conviction record of applicant under Federal and State laws relating to the manufacture, distribution, or dispensing of such substances; (5) past experience in the manufacture of controlled substances, and the existence in the establishment of effective control against diversion; and (6) such other factors as may be relevant to and consistent with the public health and safety. **(b) Distributors of controlled substances in schedule I or II** The Attorney General shall register an applicant to distribute a controlled substance in schedule I or II unless he determines that the issuance of such registration is inconsist

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 802 — Definitions

As used in this subchapter: (1) The term “addict” means any individual who habitually uses any narcotic drug so as to endanger the public morals, health, safety, or welfare, or who is so far addicted to the use of narcotic drugs as to have lost the power of self-control with reference to his addiction. (2) The term “administer” refers to the direct application of a controlled substance to the body of a patient or research subject by— (A) a practitioner (or, in his presence, by his authorized agent), or (B) the patient or research subject at the direction and in the presence of the practitioner, whether such application be by injection, inhalation, ingestion, or any other means. (3) The term “agent” means an authorized person who acts on behalf of or at the direction of a manufacturer, distributor, or dispenser; except that such term does not include a common or contract carrier, public warehouseman, or employee of the carrier or warehouseman, when acting in the usual and lawful course of the carrier’s or warehouseman’s business. (4) The term “Drug Enforcement Administration” means the Drug Enforcement Administration in the Department of Justice. (5) The term “control” means to add a drug or other substance, or immediate precursor, to a schedule under part B of this subchapter, whether by transfer from another schedule or otherwise. (6) The term “controlled substance” means a drug or other substance, or immediate precursor, included in schedule I, II, III, IV, or V of part B of this subchapter. The term does not include distilled spirits, wine, malt beverages, or tobacco, as those terms are defined or used in subtitle E of the Internal Revenue Code of 1986. (7) The term “counterfeit substance” means a controlled substance which, or the container or labelin

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21 U.S.C. § 802 — Definitions

Page 782 TITLE 21—FOOD AND DRUGS § 801a ing it into counterfeit opioid pills. Because fentanyl is lethal in even miniscule doses, this is an extremely deadly tactic, as it too often causes users to ingest a fatal amount unknowingly. SEC. 2. Agency Action. The Secretary of Health and Human Services shall, consistent with section 319 of the Public Health Service Act, 42 U.S.C. 247d, consider declaring that the drug demand and opioid crisis de- scribed in section 1 of this memorandum constitutes a Public Health Emergency. Additionally, the heads of executive departments and agencies, as appropriate and consistent with law, shall exercise all appropriate emergency authorities, as well as other relevant au- thorities, to reduce the number of deaths and minimize the devastation the drug demand and opioid crisis in- flicts upon American communities. SEC. 3. General Provisions. (a) Nothing in this memo- randum shall be construed to impair or otherwise af- fect: (i) the authority granted by law to an executive de- partment or agency, or the head thereof; or (ii) the functions of the Director of the Office of Man- agement and Budget relating to budgetary, administra- tive, or legislative proposals. (b) This memorandum shall be implemented con- sistent with applicable law and subject to the avail- ability of appropriations. (c) This memorandum is not intended to, and does not, create any right or benefit, substantive or proce- dural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person. (d) The Secretary of Health and Human Services is hereby authorized and directed to publish this memo- randum in the Federal Register. DONALD J. TRUMP. § 801a

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 822 — Persons required to register

Page 805 TITLE 21—FOOD AND DRUGS § 822 (D) any actions taken by the manufacturer to prevent diversion of the drug product; and (E) such other factors as are relevant to and consistent with the public health and safety, including the factors described in subsection (b) as applied to the drug prod- uct. (3) Status pending application for reinstate- ment A transaction involving a particular drug product that is the subject of a bona fide pend- ing application for reinstatement of exemp- tion filed with the Attorney General not later than 60 days after a regulation removing the exemption is issued pursuant to subsection (a) shall not be considered to be a regulated transaction if the transaction occurs during the pendency of the application and, if the At- torney General denies the application, during the period of 60 days following the date on which the Attorney General denies the appli- cation, unless— (A) the Attorney General has evidence that, applying the factors described in sub- section (b) to the drug product, the drug product is being diverted; and (B) the Attorney General so notifies the applicant. (4) Amendment and modification A regulation reinstating an exemption under paragraph (1) may be modified or revoked with respect to a particular drug product upon a finding that— (A) applying the factors described in sub- section (b) to the drug product, the drug product is being diverted; or (B) there is a significant change in the data that led to the issuance of the regula- tion. (Pub. L. 91–513, title II, § 204, as added Pub. L. 103–200, § 2(b)(1), Dec. 17, 1993, 107 Stat. 2334; amended Pub. L. 104–237, title IV, § 401(c), Oct. 3, 1996, 110 Stat. 3108; Pub. L. 109–177, title VII, § 712(a)(2), Mar. 9, 2006, 120 Stat. 263.) Editorial No

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 823 — Registration requirements

Page 809 TITLE 21—FOOD AND DRUGS § 823 (2) a manufacturer, distributor, or reverse distributor of prescription medications; (3) a retail pharmacy; (4) a registered narcotic treatment program; (5) a hospital or clinic with an onsite phar- macy; (6) an eligible long-term care facility; or (7) any other entity authorized by the Drug Enforcement Administration to dispose of pre- scription medications. (b) Program authorized The Attorney General, in coordination with the Administrator of the Drug Enforcement Ad- ministration, the Secretary of Health and Human Services, and the Director of the Office of National Drug Control Policy, shall coordi- nate with covered entities in expanding or mak- ing available disposal sites for unwanted pre- scription medications. (Pub. L. 114–198, title II, § 203, July 22, 2016, 130 Stat. 717.) Editorial Notes CODIFICATION Section was enacted as part of the Comprehensive Addiction and Recovery Act of 2016, and not as part of the Controlled Substances Act which comprises this subchapter. Statutory Notes and Related Subsidiaries ACCESS TO INCREASED DRUG DISPOSAL Pub. L. 115–271, title III, subtitle B, ch. 6, Oct. 24, 2018, 132 Stat. 3950, provided that: ‘‘SEC. 3251. SHORT TITLE. ‘‘This chapter may be cited as the ‘Access to In- creased Drug Disposal Act of 2018’. ‘‘SEC. 3252. DEFINITIONS. ‘‘In this chapter— ‘‘(1) the term ‘Attorney General’ means the Attor- ney General, acting through the Assistant Attorney General for the Office of Justice Programs; ‘‘(2) the term ‘authorized collector’ means a nar- cotic treatment program, a hospital or clinic with an on-site pharmacy, a retail pharmacy, or a reverse dis- tributor, that is authorized as a collector under sec- tion 1317.40 of title 21, Code of Federal Regulations (or a

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Federal law — U.S. Code and appendices · legal_authorities

38 U.S.C. § 7414 — Compliance with requirements for exam-

Page 1229 TITLE 38—VETERANS’ BENEFITS § 7414 the Department, as calculated over the five-year period preceding the determination. (b) RECRUITMENT AND APPOINTMENT.—Notwith- standing sections 3304 and 3309 through 3318 of title 5, the Secretary may, upon a determination by the Inspector General under subsection (a) that there is a staffing shortage throughout the Department with respect to a particular occupa- tion, recruit and directly appoint, during the fis- cal year after the fiscal year during which such determination is made, qualified personnel to serve in that particular occupation for the De- partment. (Added Pub. L. 113–146, title III, § 301(a)(1), Aug. 7, 2014, 128 Stat. 1784; amended Pub. L. 114–315, title VIII, § 802(4), Dec. 16, 2016, 130 Stat. 1592; Pub. L. 115–46, title II, § 201, Aug. 12, 2017, 131 Stat. 959.) Editorial Notes AMENDMENTS 2017—Subsec. (a). Pub. L. 115–46 substituted ‘‘at a minimum, the five clinical occupations and the five nonclinical occupations’’ for ‘‘the five occupations’’ and ‘‘with respect to each medical center of the Depart- ment,’’ for ‘‘throughout the Department’’. 2016—Subsec. (b). Pub. L. 114–315 substituted ‘‘under subsection (a)’’ for ‘‘under paragraph (1)’’. Statutory Notes and Related Subsidiaries DEADLINE FOR FIRST DETERMINATION Pub. L. 113–146, title III, § 301(a)(3), Aug. 7, 2014, 128 Stat. 1784, provided that: ‘‘Notwithstanding the dead- line under section 7412 of title 38, United States Code, as added by paragraph (1), for the annual determination of staffing shortages in the Veterans Health Adminis- tration, the Inspector General of the Department of Veterans Affairs shall make the first determination re- quired under such section, and the Secretary of Vet- erans Affairs shall publish in the

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Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 11101 — Findings

Page 8114 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 11101 1 So in original. Probably should be ‘‘for purposes of subpara- graph (A),’’. Sec. 11115. Construction. SUBCHAPTER II—REPORTING OF INFORMATION 11131. Requiring reports on medical malpractice payments. 11132. Reporting of sanctions taken by Boards of Medical Examiners. 11133. Reporting of certain professional review ac- tions taken by health care entities. 11134. Form of reporting. 11135. Duty of hospitals to obtain information. 11136. Disclosure and correction of information. 11137. Miscellaneous provisions. SUBCHAPTER III—DEFINITIONS AND REPORTS 11151. Definitions. 11152. Reports and memoranda of understanding. § 11101. Findings The Congress finds the following: (1) The increasing occurrence of medical malpractice and the need to improve the qual- ity of medical care have become nationwide problems that warrant greater efforts than those that can be undertaken by any indi- vidual State. (2) There is a national need to restrict the ability of incompetent physicians to move from State to State without disclosure or dis- covery of the physician’s previous damaging or incompetent performance. (3) This nationwide problem can be remedied through effective professional peer review. (4) The threat of private money damage li- ability under Federal laws, including treble damage liability under Federal antitrust law, unreasonably discourages physicians from par- ticipating in effective professional peer re- view. (5) There is an overriding national need to provide incentive and protection for physi- cians engaging in effective professional peer review. (Pub. L. 99–660, title IV, § 402, Nov. 14, 1986, 100 Stat. 3784.) Statutory Notes and Related Subsidiaries SHORT TITLE Pub. L.

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