Medical Products Wholesalers Annual submission of certain information to Board; review and contents of marketing code of conduct.
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, In determining the public interest, the following factors shall be considered: The Attorney General may deny an application for such registration or such modification of registration if the Attorney General determines that the issuance of such registration or modification would be inconsistent with the public interest.
Separate registration under this part for practitioners engaging in research with controlled substances in schedule II, III, IV, or V, who are already registered under this part in another capacity, shall not be required.
Registration applications by practitioners wishing to conduct research with controlled substances in schedule I shall be referred to the Secretary, who shall determine the qualifications and competency of each practitioner requesting registration, as well as the merits of the research protocol.
The Secretary, in determining the merits of each research protocol, shall consult with the Attorney General as to effective procedures to adequately safeguard against diversion of such controlled substances from legitimate medical or scientific use.
Registration for the purpose of bona fide research with controlled substances in schedule I by a practitioner deemed qualified by the Secretary may be denied by the Attorney General only on a ground specified in section a of this title.
Article 7 of the Convention on Psychotropic Substances shall not be construed to prohibit, or impose additional restrictions dea diversion investigator writing assessment, research involving drugs or other substances scheduled under the convention which is conducted in conformity with this subsection and other applicable provisions of this subchapter.
The Attorney General shall register an applicant to dispense narcotic drugs to individuals for maintenance treatment or detoxification treatment or both A if the applicant is a practitioner who is determined by the Secretary to be qualified under standards established by the Secretary to engage in the treatment with respect to which registration is sought; B if the Attorney General determines that the applicant will comply with standards established by the Attorney General respecting i security of stocks of narcotic drugs for such treatment, and ii the maintenance of records in accordance with section of this title on such drugs; and C if the Secretary determines that the applicant will comply with standards established by the Secretary after consultation with the Attorney General respecting the quantities of narcotic drugs which may be provided for unsupervised use by individuals in such treatment.
B For purposes of subparagraph Athe conditions specified in this subparagraph with respect to a practitioner are that, before the initial dispensing of narcotic drugs in schedule III, IV, or V or combinations of such drugs to patients for maintenance or detoxification treatment, the practitioner submit to the Secretary a dea diversion investigator writing assessment of the intent of the practitioner to begin dispensing the drugs or combinations for such purpose, and that the notification contain the following certifications by the practitioner: Except as provided in subclause IIthe applicable number is II The applicable number is if, not sooner than 1 year after the date on which the practitioner submitted the initial notification, the practitioner submits a second notification to the Secretary of the need and intent of the practitioner to treat up to patients.
III The Secretary may by regulation change such applicable number. IV The Secretary may exclude from the applicable number patients to whom such drugs or combinations of drugs are directly administered by the qualifying practitioner in the office setting. C For purposes of subparagraph Athe conditions specified in this subparagraph with respect to narcotic drugs in schedule III, IV, or V or combinations of such drugs are as follows: For purposes of this clause, an adverse determination is a determination published in the Federal Register and made by the Secretary, after consultation with the Attorney General, that the use of the drugs or combinations of drugs for maintenance or detoxification treatment requires additional standards respecting the qualifications of practitioners to provide such treatment, or requires standards respecting the quantities of the drugs that may be provided for unsupervised use.
D i A waiver under subparagraph A with respect to a practitioner is not in effect unless in addition to conditions under subparagraphs B and C the following conditions are met: I The notification under subparagraph B is in writing and states the name of the practitioner.
II The notification identifies the registration issued for the practitioner pursuant to subsection f. III If the practitioner is a member of a group practice, the notification states the names of the other practitioners in the practice and identifies the registrations issued for the other practitioners pursuant to subsection f.
The identification number so assigned shall be appropriate to preserve the confidentiality of patients for whom the practitioner has dispensed narcotic drugs under a waiver under subparagraph A.
If the Secretary fails to make such determination by the end of the such day period, the Attorney General shall assign the practitioner an identification number described in clause ii at the end of such period. E i If a practitioner is not registered under paragraph 1 and, in violation of the conditions specified in subparagraphs B through Ddispenses narcotic drugs in schedule III, IV, or V or combinations of such drugs for maintenance treatment or detoxification treatment, the Attorney General may, for purposes of section a 4 of this title, consider the practitioner to have committed an act that renders the registration of the practitioner pursuant to subsection f to be inconsistent with the public interest.
II For purposes of subclause Ithe publication in the Federal Register of an adverse determination by the Secretary pursuant to subparagraph C ii shall with respect to the narcotic drug or combination involved be considered to be a notification provided by the Secretary to practitioners, effective upon the expiration of the day period beginning on the date on which the adverse determination is so published.
F i With respect to the dispensing of narcotic drugs in schedule III, IV, or V or combinations of such drugs to patients for maintenance or detoxification treatment, a practitioner may, in his or her discretion, dispense such drugs or combinations for such treatment under a registration under paragraph 1 or a waiver under subparagraph A subject to meeting the applicable conditions.
G For purposes of this paragraph: I The physician holds a board certification in addiction psychiatry or addiction medicine from the American Board of Medical Specialties. IV The physician has, with respect to the treatment and management of opiate-dependent patients, completed not less than 8 hours of training through classroom situations, seminars at professional society meetings, electronic communications, or otherwise that is provided by the American Society of Addiction Medicine, the American Academy of Addiction Psychiatry, the American Medical Association, the American Osteopathic Association, the American Psychiatric Association, or any other organization that the Secretary determines is appropriate for purposes of this subclause.
Such training shall include— aa opioid maintenance and detoxification; bb appropriate clinical use of all drugs approved by the Food and Drug Administration for the treatment of opioid use disorder; cc initial and periodic patient assessments including substance use monitoring ; dd individualized treatment planning, overdose reversal, and relapse prevention; ee counseling and recovery support services; ff staffing roles and considerations; gg diversion control; and hh other best practices, as identified by the Secretary.
V The physician has participated as an investigator in one or more clinical trials leading to the approval of a narcotic drug in schedule III, IV, or V for maintenance or detoxification treatment, as demonstrated by a statement submitted to the Secretary by the sponsor of such approved drug.
VI The physician has such other training or experience as the State medical licensing board of the State in which the physician will provide maintenance or detoxification treatment considers to demonstrate the ability of the physician to treat and manage opiate-dependent patients.
VII The physician has such other training or experience as the Secretary considers to demonstrate the ability of the physician to treat and manage opiate-dependent patients.
Any criteria of the Secretary under this subclause shall be established by regulation.
Any such criteria are effective only for 3 years after the date on which the criteria are promulgated, but may be extended for such additional discrete 3-year periods as the Secretary considers appropriate for purposes of this subclause. Such an extension of criteria may only be effectuated through a statement published in the Federal Register by the Secretary during the day period preceding the end of the 3-year period involved.
II The nurse practitioner or physician assistant has— aa completed not fewer than 24 hours of initial training addressing each of the topics listed in clause ii IV through classroom situations, seminars at professional society meetings, electronic communications, or otherwise provided by the American Society of Addiction Medicine, the American Academy of Addiction Psychiatry, the American Medical Association, the American Osteopathic Association, the American Nurses Credentialing Center, the American Psychiatric Association, the American Association of Nurse Practitioners, the American Academy of Physician Assistants, or any other organization that the Secretary determines is appropriate for purposes of this subclause; or bb has such other training or experience as the Secretary determines will demonstrate the ability of the nurse practitioner or physician assistant to treat and manage opiate-dependent patients.
III The nurse practitioner or physician assistant is supervised by, or works in collaboration with, a qualifying physician, if the nurse practitioner or physician assistant is required by State law to prescribe medications for the treatment of opioid use disorder in collaboration with or under the supervision of a physician.
The Secretary may, by regulation, revise the requirements for being a qualifying other practitioner under this clause. H i In consultation with the Administrator of the Drug Enforcement Administration, the Administrator of the Substance Abuse and Mental Health Services Administration, the Director of the National Institute on Drug Abuse, and the Commissioner of Food and Drugs, the Secretary shall issue regulations through notice and comment rulemaking or issue practice guidelines to address the following:June Bryan Collier Named Director of ,Inmate TX Prison Agency.
Second-in-command Bryan Collier will be the next director of the Texas Department of Criminal Justice, taking the reins at an agency that oversees more than prisons and nearly 40, employees, the Texas Tribune reports.
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***THIS IS AN INDEPENDENT CONSUMER ADVOCACY WEBSITE PROVIDED AS A PUBLIC SERVICE***: Click the letter of the last name you . DEA- Diversion Investigator I received this email today.. "CONGRATULATIONS, you have passed the required writing assessment for DEA Diversion Program to further be considered as a Diversion Investigator.
U.S. DEPARTMENT OF JUSTICE • DRUG ENFORCEMENT ADMINISTRATION Diversion Control Division • Morrissette Drive • Springfield, VA • A teaching manual for a course in Undercover and Informant Handling Tactics, written first for the State of New York than translated into Portuguese for a State Department course presented to the Brazilian Federal Police.
Based on courses and manuals. This is a huge list of government agencies, commissions, bureaus, foundations, divisions, directorates, departments, bureaus, administrations, and institutes, many of them overlapping, redundant or unnecessary.
There is no constitutional authority for the creation .