Schedule II drugs have high potential for abuse. These drugs have a currently accepted medical use in treatment in the United States or a currently accepted medical use with severe restrictions.
Abuse of these drugs may lead to severe psychological or physical dependence. These drugs have a currently accepted medical use in treatment in the United States. Abuse of the drug may lead to moderate or low physical dependence or high psychological dependence. 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 shall register an applicant to distribute a controlled substance in schedule I or II unless he determines that the issuance of such registration is inconsistent with the public interest.
Registration granted under subsections a and b of this section shall not entitle a registrant to 1 manufacture or distribute controlled substances in schedule I or II other than those specified in the registration, or 2 manufacture any quantity of those controlled substances in excess of the quota assigned pursuant to section of this title. The Attorney General shall register an applicant to manufacture controlled substances in schedule III, IV, or V, unless he determines that the issuance of such registration is inconsistent with the public interest.
The Attorney General shall register an applicant to distribute controlled substances in schedule III, IV, or V, unless he determines that the issuance of such registration is inconsistent with the public interest. The Attorney General shall register practitioners including pharmacies, as distinguished from pharmacists to dispense, or conduct research with, controlled substances in schedule II, III, IV, or V and shall modify the registrations of pharmacies so registered to authorize them to dispense controlled substances by means of the Internet, if the applicant is authorized to dispense, or conduct research with respect to, controlled substances under the laws of the State in which he practices.
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 upon, 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 A , the 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 notification 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:.
I all drugs approved by the Food and Drug Administration for the treatment of opioid use disorder, including for maintenance, detoxification, overdose reversal, and relapse prevention; and.
Except as provided in subclause II , the applicable number is 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 A , the 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 D , dispenses 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 I , the 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.
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—. 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. VIII The physician graduated in good standing from an accredited school of allopathic medicine or osteopathic medicine in the United States during the 5-year period immediately preceding the date on which the physician submits to the Secretary a written notification under subparagraph B and successfully completed a comprehensive allopathic or osteopathic medicine curriculum or accredited medical residency that—.
AA the training described in items aa through gg of subclause IV ; and. BB training with respect to any other best practice the Secretary determines should be included in the curriculum, which may include training on pain management, including assessment and appropriate use of opioid and non-opioid alternatives.
II a qualifying other practitioner, as defined in clause iv , who is a nurse practitioner or physician assistant; or. III for the period beginning on October 1, , and ending on October 1, , a qualifying other practitioner, as defined in clause iv , who is a clinical nurse specialist, certified registered nurse anesthetist, or certified nurse midwife.
I The nurse practitioner, clinical nurse specialist, certified registered nurse anesthetist, certified nurse midwife, or physician assistant is licensed under State law to prescribe schedule III, IV, or V medications for the treatment of pain.
II The nurse practitioner, clinical nurse specialist, certified registered nurse anesthetist, certified nurse midwife, or physician assistant has—.
III The nurse practitioner, clinical nurse specialist, certified registered nurse anesthetist, certified nurse midwife, or physician assistant is supervised by, or works in collaboration with, a qualifying physician, if the nurse practitioner, clinical nurse specialist, certified registered nurse anesthetist, certified nurse midwife, 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:.
I Approval of additional credentialing bodies and the responsibilities of additional credentialing bodies. II Additional exemptions from the requirements of this paragraph and any regulations under this paragraph. III Such other elements of the requirements under this paragraph as the Secretary determines necessary for purposes of implementing such requirements. Nothing in such regulations or practice guidelines may authorize any Federal official or employee to exercise supervision or control over the practice of medicine or the manner in which medical services are provided.
The Secretary shall update such protocol in consultation with experts in opioid use disorder research and treatment. I Notwithstanding section of this title , nothing in this paragraph shall be construed to preempt any State law that—. The Attorney General shall register an applicant to distribute a list I chemical unless the Attorney General determines that registration of the applicant is inconsistent with the public interest.
Registration under this subsection shall not be required for the distribution of a drug product that is exempted under clause iv or v of section 39 A of this title. In determining the public interest for the purposes of this subsection, the Attorney General shall consider—.
Not later than 90 days after the date on which the period for comment pursuant to such notice ends, the Attorney General shall register the applicant, or serve an order to show cause upon the applicant in accordance with section c of this title , unless the Attorney General has granted a hearing on the application under section i of this title.
For the purpose of enabling emergency medical services professionals to administer controlled substances in schedule II, III, IV, or V to ultimate users receiving emergency medical services in accordance with the requirements of this subsection, the Attorney General—. A shall register an emergency medical services agency if the agency submits an application demonstrating it is authorized to conduct such activity under the laws of each State in which the agency practices; and.
B may deny an application for such registration if the Attorney General determines that the issuance of such registration would be inconsistent with the requirements of this subsection or the public interest based on the factors listed in subsection f.
In registering an emergency medical services agency pursuant to paragraph 1 , the Attorney General shall allow such agency the option of a single registration in each State where the agency administers controlled substances in lieu of requiring a separate registration for each location of the emergency medical services agency.
If a hospital-based emergency medical services agency is registered under subsection f , the agency may use the registration of the hospital to administer controlled substances in accordance with this subsection without being registered under this subsection. Emergency medical services professionals of a registered emergency medical services agency may administer controlled substances in schedule II, III, IV, or V outside the physical presence of a medical director or authorizing medical professional in the course of providing emergency medical services if the administration is—.
II provided by a medical director or authorizing medical professional in response to a request by the emergency medical services professional with respect to a specific patient—. A registered emergency medical services agency may deliver controlled substances from a registered location of the agency to an unregistered location of the agency only if the agency—.
B notifies the Attorney General at least 30 days prior to first delivering controlled substances to the unregistered location. A registered emergency medical services agency may store controlled substances—. B at any designated location of the agency or in an emergency services vehicle situated at a registered or designated location of the agency; or. C in an emergency medical services vehicle used by the agency that is—.
The delivery of controlled substances by a registered emergency medical services agency pursuant to this subsection shall not be treated as distribution for purposes of section of this title.
Notwithstanding paragraph 13 J , a registered emergency medical services agency may receive controlled substances from a hospital for purposes of restocking an emergency medical services vehicle following an emergency response, and without being subject to the requirements of section of this title , provided all of the following conditions are satisfied:.
A The registered or designated location of the agency where the vehicle is primarily situated maintains a record of such receipt in accordance with paragraph 9. B The hospital maintains a record of such delivery to the agency in accordance with section of this title. C If the vehicle is primarily situated at a designated location, such location notifies the registered location of the agency within 72 hours of the vehicle receiving the controlled substances. A registered emergency medical services agency shall maintain records in accordance with subsections a and b of section of this title of all controlled substances that are received, administered, or otherwise disposed of pursuant to the agency's registration, without regard to sub section c 1 B of this title.
A registered emergency medical services agency, under the supervision of a medical director, shall be responsible for ensuring that—. A all emergency medical services professionals who administer controlled substances using the agency's registration act in accordance with the requirements of this subsection;.
B the recordkeeping requirements of paragraph 9 are met with respect to a registered location and each designated location of the agency;. C the applicable physical security requirements established by regulation of the Attorney General are complied with wherever controlled substances are stored by the agency in accordance with paragraph 6 ; and.
D the agency maintains, at a registered location of the agency, a record of the standing orders issued or adopted in accordance with paragraph 9.
A specifying, with regard to delivery of controlled substances under paragraph 5 —. B specifying, with regard to the storage of controlled substances under paragraph 6 , the manner in which such substances must be stored at registered and designated locations, including in emergency medical service vehicles; and. C addressing the ability of hospitals, emergency medical services agencies, registered locations, and designated locations to deliver controlled substances to each other in the event of—.
A to limit the authority vested in the Attorney General by other provisions of this subchapter to take measures to prevent diversion of controlled substances; or. B to override the authority of any State to regulate the provision of emergency medical services consistent with this subsection. A The term "authorizing medical professional" means an emergency or other physician, or another medical professional including an advanced practice registered nurse or physician assistant —. B The term "designated location" means a location designated by an emergency medical services agency under paragraph 5.
C The term "emergency medical services" means emergency medical response and emergency mobile medical services provided outside of a fixed medical facility. D The term "emergency medical services agency" means an organization providing emergency medical services, including such an organization that—. E The term "emergency medical services professional" means a health care professional including a nurse, paramedic, or emergency medical technician licensed or certified by the State in which the professional practices and credentialed by a medical director of the respective emergency medical services agency to provide emergency medical services within the scope of the professional's State license or certification.
F The term "emergency medical services vehicle" means an ambulance, fire apparatus, supervisor truck, or other vehicle used by an emergency medical services agency for the purpose of providing or facilitating emergency medical care and transport or transporting controlled substances to and from the registered and designated locations. G The term "hospital-based" means, with respect to an agency, owned or operated by a hospital.
H The term "medical director" means a physician who is registered under subsection f and provides medical oversight for an emergency medical services agency. I The term "medical oversight" means supervision of the provision of medical care by an emergency medical services agency. J The term "registered emergency medical services agency" means—. K The term "registered location" means a location that appears on the certificate of registration issued to an emergency medical services agency under this subsection or subsection f , which shall be where the agency receives controlled substances from distributors.
L The term "specific State authority" means a governmental agency or other such authority, including a regional oversight and coordinating body, that, pursuant to State law or regulation, develops clinical protocols regarding the delivery of emergency medical services in the geographic jurisdiction of such agency or authority within the State that may be adopted by medical directors.
M The term "standing order" means a written medical protocol in which a medical director determines in advance the medical criteria that must be met before administering controlled substances to individuals in need of emergency medical services. N The term "verbal order" means an oral directive that is given through any method of communication including by radio or telephone, directly to an emergency medical services professional, to contemporaneously administer a controlled substance to individuals in need of emergency medical services outside the physical presence of the medical director or authorizing medical professional.
In this section, the phrase "factors as may be relevant to and consistent with the public health and safety" means factors that are relevant to and consistent with the findings contained in section of this title.
Amendatory provisions of H. This chapter, referred to in subsec. II generally. Prior to amendment, subcl. II read as follows: "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.
II read as follows: "during the period beginning on July 22, , and ending on October 1, , a qualifying other practitioner, as defined in clause iv.
For purposes of this clause, the applicable number is 30, unless, 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. A second notification under this clause shall contain the certifications required by clauses i and ii of this subparagraph.
The Secretary may by regulation change such total number. I generally. I read as follows: "The physician holds a subspecialty board certification in addiction psychiatry from the American Board of Medical Specialties. IV generally. IV read as follows: "The physician has, with respect to the treatment and management of opiate-dependent patients, completed not less than eight 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.
The protocol shall be guided by science. I and struck out former subpars. I and J which limited a State's ability to preclude a practitioner from dispensing or prescribing certain approved drugs and provided the effective date of the paragraph and authorized the Secretary and the Attorney General to make certain determinations. The" for "except that the". For purposes of this clause, the applicable number is 30, except that the Secretary may by regulation change such total number, and the Secretary for such purposes may by regulation establish different categories on the basis of the number of practitioners in a group practice and establish for the various categories different numerical limitations on the number of such patients that the group practice may have.
A to C , respectively, of par. A and B of former par. B of par. For provisional registration of persons engaged in manufacturing, distributing, or dispensing of controlled substances on the day before the effective date of section of this title who are registered on such date under section of this title or section of Title 26 , Internal Revenue Code, see section of Pub.
A registration pursuant to section of this title to manufacture, distribute, or dispense a controlled substance or a list I chemical may be suspended or revoked by the Attorney General upon a finding that the registrant—. A registration pursuant to section g 1 of this title to dispense a narcotic drug for maintenance treatment or detoxification treatment may be suspended or revoked by the Attorney General upon a finding that the registrant has failed to comply with any standard referred to in section g 1 of this title.
The Attorney General may limit revocation or suspension of a registration to the particular controlled substance or list I chemical with respect to which grounds for revocation or suspension exist. A contain a statement of the basis for the denial, revocation, or suspension, including specific citations to any laws or regulations alleged to be violated by the applicant or registrant;.
B direct the applicant or registrant to appear before the Attorney General at a time and place stated in the order, but not less than 30 days after the date of receipt of the order; and. C notify the applicant or registrant of the opportunity to submit a corrective action plan on or before the date of appearance. Such proceedings shall be independent of, and not in lieu of, criminal prosecutions or other proceedings under this subchapter or any other law of the United States.
A failure to comply with a standard referred to in section g 1 of this title may be treated under this subsection as grounds for immediate suspension of a registration granted under such section. A suspension under this subsection shall continue in effect until the conclusion of such proceedings, including judicial review thereof, unless sooner withdrawn by the Attorney General or dissolved by a court of competent jurisdiction.
The suspension or revocation of a registration under this section shall operate to suspend or revoke any quota applicable under section of this title. In the event the Attorney General suspends or revokes a registration granted under section of this title , all controlled substances or list I chemicals owned or possessed by the registrant pursuant to such registration at the time of suspension or the effective date of the revocation order, as the case may be, may, in the discretion of the Attorney General, be placed under seal.
No disposition may be made of any controlled substances or list I chemicals under seal until the time for taking an appeal has elapsed or until all appeals have been concluded except that a court, upon application therefor, may at any time order the sale of perishable controlled substances or list I chemicals.
Any such order shall require the deposit of the proceeds of the sale with the court. Upon a revocation order becoming final, all such controlled substances or list I chemicals or proceeds of sale deposited in court shall be forfeited to the United States; and the Attorney General shall dispose of such controlled substances or list I chemicals in accordance with section e of this title.
All right, title, and interest in such controlled substances or list I chemicals shall vest in the United States upon a revocation order becoming final. The Attorney General may, in his discretion, seize or place under seal any controlled substances or list I chemicals owned or possessed by a registrant whose registration has expired or who has ceased to practice or do business in the manner contemplated by his registration. Such controlled substances or list I chemicals shall be held for the benefit of the registrant, or his successor in interest.
The Attorney General shall notify a registrant, or his successor in interest, who has any controlled substance or list I chemical seized or placed under seal of the procedures to be followed to secure the return of the controlled substance or list I chemical and the conditions under which it will be returned. The Attorney General may not dispose of any controlled substance or list I chemical seized or placed under seal under this subsection until the expiration of one hundred and eighty days from the date such substance or chemical was seized or placed under seal.
The Attorney General may issue an order to prohibit, conditionally or unconditionally, and permanently or for such period as the Attorney General may determine, any person from being registered under this subchapter to manufacture, distribute, or dispense a controlled substance or a list I chemical, if the Attorney General finds that—. Subchapter II, referred to in subsecs.
Proceedings to deny, revoke, or suspend shall be conducted pursuant to this section in accordance with subchapter II of chapter 5 of title 5.
Applicability of this section to provisional registrations, see section of Pub. It shall be unlawful to distribute a controlled substance in a commercial container unless such container, when and as required by regulations of the Attorney General, bears a label as defined in section k of this title containing an identifying symbol for such substance in accordance with such regulations.
A different symbol shall be required for each schedule of controlled substances. It shall be unlawful for the manufacturer of any controlled substance to distribute such substance unless the labeling as defined in section m of this title of such substance contains, when and as required by regulations of the Attorney General, the identifying symbol required under subsection a.
The Secretary shall prescribe regulations under section b of this title which shall provide that the label of a drug listed in schedule II, III, or IV shall, when dispensed to or for a patient, contain a clear, concise warning that it is a crime to transfer the drug to any person other than the patient. It shall be unlawful to distribute controlled substances in schedule I or II, and narcotic drugs in schedule III or IV, unless the bottle or other container, stopper, covering, or wrapper thereof is securely sealed as required by regulations of the Attorney General.
I it is intended solely for investigational use as described in section i of such Act; and. II such product is being used exclusively for purposes of a clinical trial that is the subject of an effective investigational new drug application.
The Attorney General may publish in the Federal Register or on the website of the Drug Enforcement Administration a list of products which the Attorney General has determined, based on substantial evidence, contain an anabolic steroid and are not labeled in accordance with this Act and the amendments made by this Act. Except as provided in paragraph 2 , production quotas shall be established in terms of quantities of each basic class of controlled substance and not in terms of individual pharmaceutical dosage forms prepared from or containing such a controlled substance.
The Attorney General shall limit or reduce individual manufacturing quotas to the extent necessary to prevent the aggregate of individual quotas from exceeding the amount determined necessary each year by the Attorney General under subsection a. The quota of each registered manufacturer for each basic class of controlled substance in schedule I or II or for ephedrine, pseudoephedrine, or phenylpropanolamine shall be revised in the same proportion as the limitation or reduction of the aggregate of the quotas.
However, if any registrant, before the issuance of a limitation or reduction in quota, has manufactured in excess of his revised quota, the amount of the excess shall be subtracted from his quota for the following year. On or before December 1 of each year, upon application therefor by a registered manufacturer, the Attorney General shall fix a manufacturing quota for the basic classes of controlled substances in schedules I and II and for ephedrine, pseudoephedrine, and phenylpropanolamine that the manufacturer seeks to produce.
The quota shall be subject to the provisions of subsections a and b of this section. In fixing such quotas, the Attorney General shall determine the manufacturer's estimated disposal, inventory, and other requirements for the calendar year; and, in making his determination, the Attorney General shall consider the manufacturer's current rate of disposal, the trend of the national disposal rate during the preceding calendar year, the manufacturer's production cycle and inventory position, the economic availability of raw materials, yield and stability problems, emergencies such as strikes and fires, and other factors.
The Attorney General shall, upon application and subject to the provisions of subsections a and b of this section, fix a quota for a basic class of controlled substance in schedule I or II for any registrant who has not manufactured that basic class of controlled substance or ephedrine, pseudoephedrine, or phenylpropanolamine during one or more preceding calendar years.
In fixing such quota, the Attorney General shall take into account the registrant's reasonably anticipated requirements for the current year; and, in making his determination of such requirements, he shall consider such factors specified in subsection c of this section as may be relevant. At any time during the year any registrant who has applied for or received a manufacturing quota for a basic class of controlled substance in schedule I or II or for ephedrine, pseudoephedrine, or phenylpropanolamine may apply for an increase in that quota to meet his estimated disposal, inventory, and other requirements during the remainder of that year.
In passing upon the application the Attorney General shall take into consideration any occurrences since the filing of the registrant's initial quota application that may require an increased manufacturing rate by the registrant during the balance of the year.
In passing upon the application the Attorney General may also take into account the amount, if any, by which the determination of the Attorney General under subsection a of this section exceeds the aggregate of the quotas of all registrants under this section.
Notwithstanding any other provisions of this subchapter, no registration or quota may be required for the manufacture of such quantities of controlled substances in schedules I and II or ephedrine, pseudoephedrine, or phenylpropanolamine as incidentally and necessarily result from the manufacturing process used for the manufacture of a controlled substance or of ephedrine, pseudoephedrine, or phenylpropanolamine with respect to which its manufacturer is duly registered under this subchapter.
The Attorney General may, by regulation, prescribe restrictions on the retention and disposal of such incidentally produced substances or chemicals. Each reference in this section to ephedrine, pseudoephedrine, or phenylpropanolamine includes each of the salts, optical isomers, and salts of optical isomers of such chemical. B i as necessary to address a shortage of a controlled substance, increase the aggregate and individual production quotas under this section applicable to such controlled substance and any ingredient therein to the level requested; or.
The Secretary shall make the written response provided under subparagraph B ii available to the public on the Internet Web site of the Food and Drug Administration. A the request pertains to a controlled substance on the list of drugs in shortage maintained under section e of this title ;.
B the request is submitted by the manufacturer of the controlled substance; and. B In estimating diversion under this paragraph, the Attorney General—. C After estimating the amount of diversion of a covered controlled substance, the Attorney General shall make appropriate quota reductions, as determined by the Attorney General, from the quota the Attorney General would have otherwise established had such diversion not been considered.
B Not later than 1 year after October 24, , and every year thereafter, the Attorney General shall submit to the Committee on the Judiciary, the Committee on Health, Education, Labor, and Pensions, and the Committee on Appropriations of the Senate and the Committee on the Judiciary, the Committee on Energy and Commerce, and the Committee on Appropriations of the House of Representatives the following information with regard to each covered controlled substance:.
A take into consideration changes in the accepted medical use of the covered controlled substances; and. B work with the Secretary of Health and Human Services on methods to appropriately and anonymously estimate the type and amount of covered controlled substances that are submitted for collection from approved drug collection receptacles, mail-back programs, and take-back events. Schedules I and II, referred to in text, are set out in section c of this title. Not later than 6 months after July 9, , and annually thereafter, the Attorney General shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on the Judiciary of the Senate a report on drug shortages that—.
Section of this Act, referred to in par. Section was enacted as part of the Food and Drug Administration Safety and Innovation Act, and not as part of the Controlled Substances Act which comprises this subchapter. Sections to amended and repealed sections in this title and in Title 18, Crimes and Criminal Procedure, and Title 42, The Public Health and Welfare, and enacted provisions set out as notes under sections , , and of this title.
See Tables for classifications of said sections to Sections to of Pub. Part B of title III contains amendatory, repealing, and transitional provisions generally classified elsewhere. Transshipment and in-transit shipment of controlled substances.
Possession on board vessels, etc. Possession, manufacture, or distribution of controlled substance. Foreign terrorist organizations, terrorist persons and groups. Smuggling of controlled substances; investigations; oaths; subpenas; witnesses; evidence; production of records; territorial limits; fees and mileage of witnesses. Notification, suspension of shipment, and penalties with respect to importation and exportation of listed chemicals. The Department of Justice does not endorse the organizations or views represented by this site and takes no responsibility for, and exercises no control over, the accuracy, accessibility, copyright or trademark compliance or legality of the material contained on this site.
Congressional findings and declarations: controlled substances Section a. Congressional findings and declarations: psychotropic substances Section Definitions Section Authority and criteria for classification of substances Section Schedules of controlled substances Section Treatment of controlled substance analogues Section Rules and regulations Section Persons required to register Section a.
Prescription drug take back expansion Section Registration requirements Section Denial, revocation, or suspension of registration Section Labeling and packaging Section Production quotas for controlled substances Section a. Attorney General report on drug shortages Section Records and reports of registrants Section Order forms Section Prescriptions Section a. Delivery of a controlled substance by a pharmacy to an administering practitioner Section Regulation of listed chemicals and certain machines Section Additional requirements relating to online pharmacies and telemedicine Section Prohibited acts A Section Prohibited acts B Section Prohibited acts C Section Penalties for simple possession Section a.
Civil penalty for possession of small amounts of certain controlled substances Sections to b. Transferred Section Attempt and conspiracy Section Additional penalties Section Continuing criminal enterprise Section
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