istration. Before giving such advice the Secretary shall consider the qualifications of the person or persons who will conduct the research, the substances to be used, the place where research will be performed, and the design of the research protocol. Registration for the purpose of bona fide research with schedule I substances by a practitioner deemed qualified by the Secretary may be denied by the Attorney General only on a ground specified in section 304 (a) or on the ground that the applicant's past practice or proposed procedures furnish ground for the belief that the applicant will abuse or unlawfully transfer such substances or fail to safeguard adequately his supply of such substances against diversion from legitimate medical or scientific use.

(g) The Attorney General shall permit persons to register who own or operate any establishment engaged in the manufacture, distribution, or dispensing of any controlled dangerous substances prior to the effective date of this Act and who are registered under section 510 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360).

DENIAL, REVOCATION, OR SUSPENSION OF REGISTRATION

SEC. 304. (a) A registration pursuant to section 303 to manufacture, distribute, or dispense a controlled dangerous substance, may be denied, suspended, or revoked by the Attorney General upon a finding that the registrant:

(1) has materially falsified any application filed pursuant to this Act or required by this Act;

(2) has been convicted of a felony under this Act or any law of the United States, or of any State, relating to any substances defined herein as a controlled dangerous substance; or

(3) has had his State license or registration suspended or revoked by competent State authority and is no longer authorized by State law to engage in the manufacturing, distribution, or dispensing of controlled dangerous substances.

(b) The Attorney General may limit revocation or suspension of a registration to the particular controlled dangerous substance with respect to which grounds for revocation or suspension exist.

(c) Before taking action pursuant to this section, the Attorney General shall serve upon the applicant or registrant an order to show cause why registration should not be denied, revoked, or suspended. The order to show cause shall contain a statement of the basis thereof and shall call upon the applicant or registrant to appear before the Attorney General at a time and place stated in the order, but in no event less than thirty days after the date of receipt of the order. Proceedings to deny or revoke or suspend shall be conducted pursuant to this section in accordance with subchapter II of chapter 5, of title 5, of the United States Code. Such proceedings shall be independent of, and not in lieu of, criminal prosecutions or other proceedings under this Act or any law of the United States.

(d) The Attorney General may, in his discretion, suspend any registration simultaneously with the institution of proceedings under this section, in cases where he finds that there is an imminent danger to the public health or safety. Such suspension 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.

(e) The suspension or revocation of a registration under this section shall operate to suspend or revoke any quota applicable under section 306.

(f) In the event the Attorney General suspends or revokes a registration granted under section 303, all controlled dangerous substances owned or possessed by the registrant pursant 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 substances under seal until the time for taking an appeal has elapsed or until all appeals have been concluded unless a court, upon application therefor, orders the sale of perishable substances and the deposit of the proceeds of the sale with the court. Upon a revocation order becoming final, all such controlled dangerous substances shall be forfeited to the Government.

MARKING OF CONTAINERS

SEC. 305. Commercial containers of controlled dangerous substances, where appropriate, shall be identified by a symbol in accordance with the rules and regulations promulgated by the Attorney General.

QUOTAS APPLICABLE TO CERTAIN SUBSTANCES

SEC. 306. (a) The Attorney General shall determine the total quantity and establish production quotas for each controlled dangerous substance in schedules I and II to be manufactured each calendar year to provide for the estimated medical, scientific, and industrial needs of the United States, for lawful export requirements, and for the establishment and maintenance of reserve stocks.

(b) The Attorney General shall limit or reduce individual production 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 controlled dangerous substance in schedule I or II 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.

(c) On or before July 1 of each year, upon application therefor by a registered manufacturer, the Attorney General shall fix a manufacturing quota for the controlled dangerous substances in schedules I and II 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.

(d) The Attorney General shall, upon application and subject to the provisions of subsections (a) and (b) of this section, fix a quota for a controlled dangerous substance in schedule I or II for any registrant who has not manufactured that controlled dangerous substance 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, shall consider such factors specified in (c) of this section as may be relevant.

(e) At any time during the year any registrant who has applied for or received a manufacturing quota for a controlled dangerous substance in schedule I or II 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.

(f) Notwithstanding any other provisionss of this title, no registration or quota may be required for the manufacture of such quantities of controlled dangerous substances in schedules I and II that incidentally and necessarily result from the manufacturing process used for the manufacture of a controlled dangerous substance duly registered under this title. The Attorney General may, by regulations, prescribe restrictions on the retention and disposal of such incidentally produced substances.

RECORDS AND REPORTS OF REGISTRANTS

SEC. 307. Upon the effective date of this Act, each registrant manufacturing, distributing, or dispensing controlled dangerous substances in schedule I, II, III, or IV shall make a complete and accurate record of all stocks of such dangerous substances on hand. Thereafter, complete and accurate records of all such dangerous substances shall be maintained for no more than two years. Each twoyear period after the effective date of this Act, at the time of his regular fiscal inventory, each registrant manufacturing, distributing, or dispensing controlled dangerous substances shall prepare an inventory of each dangerous substance in his possession. Records and inventories shall contain such information as shall be provided by rules and regulations promulgated by the Attorney Gen

eral. This subsection shall not apply to practitioners who lawfully prescribe or administer, but otherwise dispense, controlled dangerous substances listed in schedule II, III, or IV of this Act.

ORDER FORMS

SEC. 308. (a) Controlled dangerous substances in schedules I and II shall be distributed only by a registrant, pursuant to an order form prescribed by the Attorney General.

(b) Nothing contained in subsection (a) shall apply

(1) to the administering or dispensing of such substances to a patient by a practitioner in the course of his professional practice; however, such practioner must comply with the requirement of section 307 of this Act; (2) to the distribution or dispensing of such substances by a pharmacist to an ultimate user pursuant to a written prescription issued by a practitioner authorized by State law to issue such prescription; however, such pharmacist must comply with the requirements of section 307 of this Act.

PRESCRIPTIONS

SEC. 309. (a) Except when dispensed directly by a practitioner, other than a pharmacist, to an ultimate user, no controlled dangerous substance included in schedule II, which is a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act, may be dispensed without the written prescription of a practitioner: Provided, That in emergency situations, as prescribed by the Attorney General by regulation, such drug may be dispensed upon oral prescription in accordance with section 503(b) of that Act. Prescriptions shall be retained in conformity with the requirements of section 307 of this Act. No prescription for a schedule II substance may be refilled.

(b) Except when dispensed directly by a practitioner, other than a pharmacist, to an ultimate user, no controlled dangerous substance included in schedule III which is a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act, may be dispensed without a written or oral prescription in conformity with section 503(b) of that Act. Such prescriptions may not be filled or refilled more than six months after the date thereof or be refilled more than five times after the date of the prescription unless renewed by the practitioner.

(c) No controlled dangerous substance included in schedule IV may be distributed or dispensed other than for a medical purpose.

(d) Whenever it appears to the Attorney General that a drug not considered to be a prescription drug under the Federal Food, Drug and Cosmetic Act should be so considered because of its abuse potential, he shall so advise the Secretary of Health, Education, and Welfare and furnish to him all available data relevant thereto.

TITLE IV-IMPORTATION AND EXPORTATION

IMPORTATION OF CONTROLLED DANGEROUS SUBSTANCES

SEC. 401. (a) It shall be unlawful to import or land into the United States, any controlled dangerous substance listed in schedules I and II of title II of this Act, unless pursuant to such exceptions as the Attorney General may provide by regulation as being necessary for medical, scientific, or other legitimate purposes.

(b) Controlled dangerous substances listed in schedule III may be imported for medical and other legitimate uses only, pursuant to such notification requirements, as the Attorney General may prescribe by regulation.

EXPORTATION OF CONTROLLED DANGEROUS SUBSTANCES

SEC. 402. (a) No person subject to the jurisdiction of the United States shall export or cause to be exported from the United States any nonnarcotic controlled dangerous substance listed in schedules I and II of title II of this Act to any other country unless

(1) such country has instituted and maintains a system which the Attorney General deems adequate for the control of imports of such substances;

(2) the controlled dangerous substance is consigned to a holder of such permits or licenses as may be required under the laws of the country of import;

(3) substantial evidence is furnished to the Attorney General that the dangerous substance is to be applied exclusively to medical, scientific, or other legitimate uses within the country to which exported, that it will not be exported from such country, and that there is an actual need for the dangerous substance for medical, scientific, or other legitimate uses within the country; and

(4) a permit to export the controlled dangerous substance in each instance shall have been issued by the Attorney General.

(b) Notwithstanding the provisions of section (a) of this section, the Attorney General may authorize the exportation of any nonnarcotic dangerous substance if the particular substance is to be applied to a special scientific purpose in the country of destination and the authorities of such country will permit the importation of the particular drug for such purpose.

(c) No person subject to the jurisdiction of the United States shall cause to be exported from the United States any controlled dangerous substances not requiring an export permit provided by this section to any other country unless the laws of the country to which the controlled dangerous substances are consigned permit the importation into the country, and then only if

(1) there is furnished to the Attorney General prior to export documentary proof that importation is not contrary to the laws or regulations of the country of destination;

(2) a special controlled dangerous substance invoice, in triplicate, accompanies the shipment setting forth such information as the Attorney General may prescribe to identify the parties to the shipment and the means of shipping. Two copies of the invoice shall be forwarded to the Attorney General before the controlled dangerous substances are exported from the United States.

TRANSSHIPMENT AND IN-TRANSIT SHIPMENT OF CONTROLLED DANGEROUS SUBSTANCES SEC. 403. No controlled dangerous substance listed in schedule I shall be admitted into the United States for transportation to another country, or be transferred or transshipped from one vessel, vehicle, or aircraft, to another vessel, vehicle, or aircraft, within the United States for immediate exportation or for any other purpose except for scientific, medical, or other legitimate purposes in the country of destination, and then only with the prior written approval of the Attorney General, which shall be granted or denied within twenty-one days of the request. No dangerous substances listed in schedules II and III may be so admitted, transferred, or transshipped except upon advance notice to the Attorney General.

TITLE V-OFFENSES AND PENALTIES

PROHIBITED ACTS A-PENALTIES

SEC. 501. (a) Except as authorized by this Act, it shall be unlawful for any person knowingly or intentionally :

(1) to distribute, or to possess with intent to distribute, a controlled dangerous substance;

(2) to manufacture a controlled dangerous substance:

(3) to import a controlled dangerous substance classified in schedule I or II into the United States;

(4) to export a controlled dangerous substance classified in schedule I or II from the United States;

(5) to bring or possess on board any vessel, vehicle, or aircraft under the special maritime and territorial jurisdiction of the United States a controlled dangerous substance classified in schedule I or II not constituting part of the cargo entered in the manifest or part of the official supplies of the vessel, vehicle, or aircraft; and

(6) to create, distribute, or possess with intent to distribute, a counterfeit controlled dangerous substance.

(b) It shall be unlawful for any person to manufacture or to distribute a controlled dangerous substance classified in schedule I or II:

(1) intending that such substance be unlawfully imported into the United States; or

(2) knowing that such substance will be unlawfully imported into the United States.

This subsection is intended to reach acts of manufacture or distribution committed outside the territorial jurisdiction of the United States. Any person who violates this subsection shall be tried in the United States district court at the point of entry where such person enters the United States, or in the United States District Court for the District of Columbia.

(c) Any person who violates this section with respect to:

(1) any controlled dangerous substances classified in schedule I or II shall be sentenced to a term of imprisonment for not less than five years and not more than twenty years, or fined not more than $25,000, or both. Imposition or execution of such sentence shall not be suspended and probation shall not be granted.

(2) any controlled dangerous substance classified in schedule III shall be sentenced to a term of imprisonment for not more than five years, or fined not more than $15,000, or both.

(3) any controlled dangerous substance classified in schedule IV shall be sentenced to a term of imprisonment for not more than one year, or fined not more than $5,000, or both.

(d) It is unlawful for any person knowingly or intentionally to possess a controlled dangerous substance unless such substance was obtained directly or pursuant to a valid prescription or order from a practitioner, while acting in the course of his professional practice, or except as otherwise authorized by this Act. Any person who violates this subsection with respect to a drug in schedule I or II shall be sentenced to a term of imprisonment for not less than two years nor more than ten years, a fine of not more than $20,000, or both. Any person who violates this section with respect to any other substance controlled under this Act shall be sentenced to a term of imprisonment for not more than one year, a fine of not more than $5,000, or both.

PROHIBITED ACTS B-PENALTIES

SEC. 502. (a) It shall be unlawful for any person:

(1) who is subject to the requirements of title II of this Act to distribute or dispense a controlled dangerous substance in violation of section 309; (2) who is a registrant to manufacture, distribute, or dispense a controlled dangerous substance not authorized by his registration to another registrant or other authorized person;

(3) to bring a controlled dangerous substance classified in schedule I, II, or III into the United States or the special maritime or territorial jurisdiction of the United States for transshipment to another country, or to transfer or transship such a substance from one vessel to another within the United States for immediate exportation or for any other purpose-in violation of section 403 of this Act:

(4) who is a registrant to omit from any container of a controlled dangerous substance the symbol required by section 305 of this Act;

(5) to remove, alter, or obliterate a symbol required by section 305 of this Act;

(6) to refuse or fail to make, keep or furnish any record, report, notification, order form, statement, invoice or information required under this Act;

or

(7) to refuse any entry into any premises or inspection authorized by this Act.

(b) It shall be unlawful for any person who is a registrant to manufacture a controlled dangerous substance which is

(1) not expressly authorized by his registration and by a quota assigned to him pursuant to section 306 of this Act; or,

(2) in excess of a quota assigned to him pursuant to section 306 of this Act.

(c) Any person who violates this section is punishable by a civil fine of not more than $25,000: Provided, That if the violation is prosecuted by an information or indictment which alleges that the violation was committed knowingly or intentionally, and the trier of fact specifically finds that the violation was committed knowingly or intentionally, such jerson is punishable by imprisonment for not more than one year, or a fine of not more than $25,000, or both.