given away, used in the production of another basic class of narcotic drug for which the manufacturer is licensed, or otherwise disposed of (as such or contained in or combined with other drugs compounded by the manufacturer of such basic class) by the manufacturer during a stated period, less the quantity of any such basic class of narcotic drug returned to the manufacturer by a customer and any quantity sold or transferred to another licensed manufacturer of the same basic class of narcotic drug.

(i) The term "narcotic precursor" means a substance other than a narcotic drug which the Secretary or his delegate has found, after due notice and opportunity for public hearing

(1) is an immediate chemical precursor of a narcotic drug;

(2) is produced primarily for use in the manufacture of a narcotic drug; and

(3) is used, or is likely to be used, in the manufacture of a narcotic drug by persons other than persons licensed to manufacture such narcotic drug.

(Pub. L. 86-429, § 3, Apr. 22, 1960, 74 Stat. 55.) REFERENCES IN TEXT

This chapter, referred to in the text, was in the original "this Act", meaning Pub. L. 86-429, which added this chapter and amended section 182 of this title and sections 4702(a) and 4731 (a), (g) of Title 26, Internal Revenue Code of 1954.

Section 4731(a) of Title 26, as amended by section 4 of this Act, referred to in subsec. (e), means section 4731 (a) of Title 26, as amended by sections 4 of Pub. L. 86-429.

EFFECTIVE DATE

Section effective Jan. 1, 1961, see section 22 of Pub. L. 86-429, set out as a note under section 501 of this title.

§ 503. Notifications, findings and decisions under 1948 protocol.

(a) Before a notification may be sent on behalf of the United States to the Secretary General of the United Nations, under article 1 of the 1948 protocol, that a drug is considered liable to the same kind of abuse and productive of the same kind of harmful effects as the drugs specified in article 1, paragraph 2, of the 1931 convention, such drug shall have been found by the Secretary or his delegate to be an "opiate", as defined in section 4731(g) of Title 26, as amended by section 4(b) of this Act, and so proclaimed in accordance with the procedure prescribed by section 4731(g) as amended by section 4(b) of this Act.

(b) With respect to any drug which is or may be used for medical or scientific purposes and to which the 1931 convention does not apply, and which is liable to the same kind of abuse and productive of the same kind of harmful effects as the drugs specified in article 1, paragraph 2 of the 1931 convention, upon receipt by the United States of a finding or decision made pursuant to article 1 or article 2 of the 1948 protocol that any such drug is capable of producing addiction or of conversion into a drug capable of producing addiction and that the appropriate provisions of the 1931 convention shall apply to such drug, such finding or decision shall be transmitted to the Secretary or his delegate. The Secretary or his delegate shall cause such finding or decision to be published in the Federal Register unless such drug has already been determined to

be an opiate under the procedure prescribed by section 4731(g) of Title 26, as amended by section 4 of this Act. From the time of such publication, such drug shall be an opiate to the same extent as if the procedure prescribed by section 4731(g) of Title 26, as amended by section 4 of this Act, had been followed with respect to such drug.

(c) If the finding or decision so received and published in the Federal Register relates to a drug which has not previously been determined to be an opiate under the procedure prescribed by section 4731(g) of Title 26, as amended by section 4 of this Act, any person in the United States interested in the domestic manufacture and distribution of such drug for medical and scientific purposes may submit to the Secretary or his delegate written data, views, and argument opposed to such finding or decision. Such written data, views, and argument shall be transmitted to the Secretary General of the United Nations for consideration by the World Health Organization or the Commission on Narcotic Drugs of the United Nations, as the case may be, under article 3 of the 1948 protocol. If thereafter the United States receives a revised finding or decision, under article 3 of the 1948 protocol, that such a drug is not capable of producing addiction or conversion into a drug capable of producing addiction and that the provisions of the 1931 convention shall not apply to such drug, such revised finding or decision shall be transmitted to the Secretary or his delegate, who shall cause such revised finding or decision to be published in the Federal Register within ninety days of receipt thereof by the Secretary or his delegate. From the time of such publication, such drug shall cease to be an opiate, unless the Secretary or his delegate has theretofore initiated an opiate procedure under section 4731(g) of Title 26, as amended by section 4 of this Act.

(d) Upon receipt by the United States of a revised finding or decision under article 3 of the 1948 protocol (except a revised finding or decision to which subsection (c) of this section applies) that a drug (theretofore subject to the Federal narcotic laws as an opiate) is not capable of producing addiction or conversion into a drug capable of producing addiction and that the provisions of the 1931 convention shall not apply to such drug, the revised finding or decision shall be transmitted to the Secretary or his delegate. The Secretary or his delegate may, in his discretion, publish the revised finding or decision in the Federal Register and, from the time of such publication, such drug shall cease to be an opiate. If the revised finding or decision is not so published in the Federal Register, the said drug shall continue to be an opiate. (Pub. L. 86-429, § 5, Apr. 22, 1960, 74 Stat. 59.)

REFERENCES IN TEXT

Section 4731(g) of Title 26, as amended by section 4(b) of this Act, referred to in subsec. (a), means section 4731(g) of Title 26, as amended by section 4(b) of Pub. L. 86-429.

Section 4731(g) of Title 26, as amended by section 4 of this Act, referred to in subsecs. (b) and (c), means section 4731(g) of Title 26, as amended by section 4 of Pub. L. 86-429.

EFFECTIVE DATE

Section effective Jan. 1, 1961, see section 22 of Pub. L. 86-429, set out as a note under section 501 of this title.

§ 504. Modification of list of basic narcotic drugs. The Secretary or his delegate, upon his initiative or upon the petition of any interested person shall have the power by rule made on the record after opportunity for hearing, to alter classifications set forth in section 502(g) of this title by adding to, subtracting from, or further defining such classifications or any one or more of them, on the basis of their chemical structure and content and addiction liability or convertibility into an addicting drug. No new basic class shall be added unless with respect to any drug or drugs falling within such class the Secretary or his delegate shall have determined that such drug is a narcotic drug as defined by section 4731 of Title 26, as amended by section 4 of this Act, or has caused a finding or decision to be published in the Federal Register pursuant to section 503 of this title. For purposes of this section, the Secretary or his delegate may consider changes in classification established by the World Health Organization or its successor in function. (Pub. L. 86-429, § 6, Apr. 22, 1960, 74 Stat. 61.)

REFERENCES IN TEXT

Section 4731 of Title 26, as amended by section 4 of this Act, referred to in the text, means section 4731 of Title 26, as amended by section 4 of Pub. L. 86-429.

EFFECTIVE DATE

Section effective Jan. 1, 1961, see section 22 of Pub. L. 86-429, set out as a note under section 501 of this title. § 505. Restrictions on the manufacture of narcotic drugs.

(a) Except as otherwise provided in this chapter, it shall be unlawful for any person to manufacture any narcotic drug unless

(1) such narcotic drug falls within a basic class of narcotic drugs established by or pursuant to this chapter, and

(2) such person holds a currently effective license and manufacturing quota with respect to such basic class of narcotic drug issued pursuant to section 506 of this title.

(b) The omission of a narcotic drug from the classification established pursuant to section 502(g) of this title shall not be construed to permit the manufacture of such narcotic drug, the intent of this chapter being to limit the manufacture of narcotic drugs in the United States to those narcotic drugs established under this chapter as a basic class of narcotic drugs or as a member of a basic class of narcotic drugs. The fact that the Secretary or his delegate shall have—

(1) determined that a drug is a narcotic drug as defined by section 4731 of Title 26, as amended by section 4 of this Act, or

(2) caused a finding or decision with respect to any drug or other substance to be published in the Federal Register pursuant to section 503 of this title,

shall not require the Secretary or his delegate to add such narcotic drug to the classifications set forth in section 502(g) of this title or to grant a manufacturing quota for such narcotic drug, if the Secretary or his delegate shall determine that it is contrary to the public health and safety to permit

the manufacture of such drug within the United States.

(c) It shall be unlawful for any person (1) to manufacture or attempt to manufacture any narcotic drug, or (2) to knowingly permit the manufacture of any narcotic drug, in or upon any place owned, leased, occupied, used or controlled by him unless he (or the lessee, tenant, or other occupant as the case may be) is the holder of a license and quota for the manufacture during the period in question of such narcotic drug in accordance with the provisions of sections 502(g), 506, and 509 of this title; and it shall be unlawful for the holder of any such quota to manufacture during the period for which the quota is applicable any quantity of such narcotic drug in excess of the amount authorized by such quota. (Pub. L. 86-429, § 7, Apr. 22, 1960, 74 Stat. 61.)

REFERENCES IN TEXT

This chapter, referred to in the text, was in the original "this Act", meaning Pub. L. 86-429, which added this chapter and amended section 182 of this title and sections 4702 (a) and 4731 (a), (g) of Title 26, Internal Revenue Code of 1954.

Section 4731 of Title 26, as amended by section 4 of this Act, referred to in subsec. (b) (1), means section 4731 of Title 26, as amended by section 4 of Pub. L. 86-429.

EFFECTIVE DATE

Section effective Jan. 1, 1961, see section 22 of Puh L. 86-429, set out as a note under section 501 of this title.

§ 506. Licenses to manufacture narcotic drugs. (a) Application; separate licenses for basic classes of narcotic drugs; determination.

Every person who manufactures a basic class or classes of narcotic drug shall, on or before January 1, 1961, if then already engaged in such manufacture, or otherwise before engaging in such manufacture, obtain from the Secretary or his delegate a license or licenses for the appropriate basic class or classes of narcotic drug. There shall be a separate license for the manufacture of each basic class of narcotic drug. In determining whether to issue a license for a particular basic class of narcotic drug to a particular applicant, the Secretary or his delegate shall be governed by the following factors

(1) maintenance of effective controls against the diversion of the particular basic class of narcotic drug and of narcotic drugs compounded therefrom into other than legitimate medical and scientific channels through limitation of manufacture of the particular basic class of narcotic drug to the smallest number of establishments which will produce an adequate and uninterrupted supply of narcotic drugs of or derived from such basic class of narcotic drugs for medical and scientific purposes, consistent with the public interest; and

(2) compliance with the obligations undertaken by the United States pursuant to the 1931 convention and the 1948 protocol; and

(3) promotion of technical advances in the art of manufacturing narcotic drugs and the development of new narcotic drug products; and

(4) the applicant's education, moral character and reputation, the applicant's past drug manufacturing experience and the quality of his products, his technical competence, the existence in the applicant's establishment of adequate safeguards against diversion of narcotic drugs into other than legitimate medical and scientific channels; and

(5) such other factors as may be relevant to and consistent with the public interest.

(b) Registration; form and term of license; limitations.

Registration pursuant to section 4722 of Title 26, shall be a prerequisite to the issuance of any license under this section. Licenses shall be in such form as the Secretary or his delegate shall prescribe and shall continue in effect subject only to annual renewal of registration unless revoked pursuant to section 507 of this title or voluntarily surrendered. Issuance of a license pursuant to this section shall not entitle the licensee to perform any act with respect to narcotic drugs as to which the consent or approval of the Secretary or his delegate is required by the provisions of this or any other Act. (c) Manufacture of other basic classes of narcotic drugs.

Issuance of a license for the manufacture of any one basic class of narcotic drug shall not entitle the holder thereof to manufacture for sale, distribution, or other use any other basic class of narcotic drug. (d) Production of limited quantities of narcotics for research or testing; reports.

Notwithstanding the foregoing provisions of this section, the Secretary or his delegate shall authorize any person registered as a manufacturer or as a person engaged in research under section 4722 of Title 26, who meets the standards for licensing under subsection (a) (4) of this section, whether or not such person actually holds a license under subsection (a) of this section, to produce such limited quantities as the Secretary or his delegate may specify of any narcotic drug, except crude opium or coca leaves, whether or not a basic class for such drug has been established under section 502(g) of this title, exclusively for research in the development of manufacturing processes for the drug, or for chemical, pharmacological or medical testing of such drugs, for fitness for medical or scientific use and for determination of its suitability for general manufacture and distribution for medical or scientific use. Such person shall make such reports as the Secretary or his delegate may require relating to the quantities of narcotic drug manufactured and to use and disposal of such quantities of such narcotic drug. Such quantities of such narcotic drug may be disposed of only in accordance with the regulations of the Secretary or his delegate. Any authorization made under this subsection shall be subject to revocation or suspension in accordance with the procedure set forth in section 507 of this title.

(e) Compliance with Administrative Procedure Act. In issuing or refusing to issue manufacturing licenses pursuant to this section, the Secretary or his delegate shall act in conformity with the pro

cedure prescribed by section 1004 of Title 5 and the Secretary or his delegate shall be deemed to constitute "the agency" for purposes of compliance with sections 1006 and 1007 of Title 5. Each licensee of the basic class of narcotic drug with respect to which a license is sought to be obtained shall be deemed a person entitled to notice within the meaning of section 1004 (a) of Title 5. (Pub. L. 86-429, § 8, Apr. 22, 1960, 74 Stat. 62.)

REFERENCES IN TEXT

This Act, referred to in subsec. (b), means Pub. L. 86-429, which is classified to this chapter, section 182 of this title and sections 4702 (a) and 4731 (a), (g) of Title 26, Internal Revenue Code of 1954.

EFFECTIVE DATE

Subsec. (a) of this section effective Apr. 22, 1960, and subsecs. (b)-(e) of this section effective Jan. 1, 1961, see section 22 of Pub. L. 86-429, set out as a note under section 501 of this title.

§ 507. Revocation or suspension of licenses. (a) Grounds.

Any license issued pursuant to section 506 of this title may be revoked by the Secretary or his delegate if the licensee

(1) has been convicted of violating or conspiring to violate any law of the United States or of any State where the offense involves any activity or transaction with respect to narcotic drugs; or (2) has violated or failed to comply with any duly promulgated regulation of the Secretary or his delegate relating to narcotic drugs, and such violation or failure to comply reflects adversely on the licensee's reliability and integrity with respect to narcotic drugs.

In the case of a licensee holding more than one license issued pursuant to section 506 of this title, revocation may be in the discretion of the Secretary or his delegate extended to all licenses held by such licensee.

(b) Procedure.

Before revoking any license pursuant to subsection (a) of this section, the Secretary or his delegate shall serve upon the licensee an order to show cause why an order of revocation should not be issued.

Any such order to show cause shall contain a statement of the basis thereof, and shall call upon such licensee to appear before the Secretary or his delegate at a time and place stated in the order, but in no event less than thirty days after the date of receipt of such order, and give evidence upon the matter specified therein. The Secretary or his delegate may in his discretion suspend any license simultaneously with the issuance of an order to show cause, in cases where he finds that the public health, safety, or interest require such suspension. Such suspension shall continue in effect until the conclusion of any revocation proceeding, including judicial review thereof, unless sooner withdrawn by the Secretary or his delegate, or dissolved by a court of competent jurisdiction. Every hearing held pursuant to this section shall be conducted in accordance with section 1004 of Title 5 and the Secretary or his delegate shall be deemed to constitute "the agency" for purposes of compliance with sections 1006 and 1007 of Title 5. If after hearing, default, or waiver thereof by the licensee, the Secretary or

his delegate determines that an order of revocation should issue, he shall issue such order, which shall include a statement of his findings and the grounds and reasons therefor and shall specify the effective date of the order, and he shall cause such order to be served on the licensee. In any case, where a hearing is conducted pursuant to the provisions of this section both the burden of proceeding with the introduction of evidence and the burden of proof shall be upon the Secretary or his delegate. Proceedings under this section shall be independent of, and not in lieu of, criminal prosecution or other proceedings under this chapter or any other law of the United States. (Pub. L. 86-429, § 9, Apr. 22, 1960, 74 Stat. 63.)

REFERENCES IN TEXT

This chapter, referred to in the text, was in the original "this Act", meaning Pub. L. 86-429, which added this chapter and amended section 182 of this title and sections 4702(a) and 4731 (a) (g) of Title 26, Internal Revenue Code of 1954.

EFFECTIVE DATE

Section effective Jan. 1, 1961, see section 22 of Pub. L. 86-429, set out as a note under section 501 of this title. § 508. Seizure of narcotic drugs, order forms, and tax stamps upon suspension or revocation of license. In the event of the suspension or revocation of a license obtained under section 506 of this title, all narcotic drugs owned or possessed by such person at the time of suspension or at the effective date of the revocation order, as the case may be, whether or not taxes have been paid on such narcotic drugs, together with all unused order forms or narcotic tax stamps owned or possessed by such person, may at the discretion of the Secretary or his delegate be placed under seal and no disposition made until the time for taking an appeal has elapsed or until all appeals have been concluded. Upon a suspension or revocation order becoming final all narcotic drugs, tax stamps, and order forms shall be forfeited to the Government. (Pub. L. 86-429, § 10, Apr. 22, 1960, 74 Stat. 64.)

EFFECTIVE DATE

Section effective Jan. 1, 1961, see section 22 of Pub. L. 86-429, set out as a note under section 501 of this title. § 509. Manufacturing quotas for basic classes of narcotic drugs.

(a) Determination of quantity of drugs.

For the purpose of fixing manufacturing quotas under this section and in order to carry out the treaty obligations of the United States, the Secretary or his delegate shall make determinations of the total quantity of each basic class of narcotic drug necessary to be manufactured during each calendar year to provide for the estimated medical and scientific needs of the United States, for lawful export requirements, and for establishment and maintenance of reserve stocks.

(b) Limitation or reduction of quotas.

In fixing individual manufacturing quotas for any basic class of narcotic drug for a calendar year pursuant to this section, or at any time after fixing such individual quotas, the Secretary or his delegate shall limit or reduce such individual quotas to the extent necessary to prevent the aggregate of such

individual quotas from exceeding the amount of the determination of the Secretary or his delegate under subsection (a) of this section. In any such limitation or reduction pursuant to this subsection the quota of each licensed manufacturer of such basic class of drug shall be limited or reduced in the same proportion as the limitation or reduction of the aggregate of such quotas. However, if any licensee, before the issuance of a limitation or reduction in quota, has manufactured in excess of his quota so limited or reduced, the amount of such excess shall be subtracted from such licensee's manufacturing quota for the following year.

(c) Application for quota; formula; minimum quota. On or before June 1 of each year, upon application therefor by a person having a license to manufacture a basic class of narcotic drug, the Secretary or his delegate shall fix a manufacturing quota for such calendar year for such basic class of narcotic drug for such persons. Subject to the provisions of subsections (a) and (b) of this section, such quota shall be sufficient to cover the applicant's estimated disposal, inventory, and other requirements for the calendar year as determined by the Secretary or his delegate, who shall take into account the applicant's current disposal rate, the trend of such disposal rate during the preceding calendar year, the applicant'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. Subject to the provisions of subsections (a) and (b) of this section, such quota shall not be less than the sum of

(1) such licensed manufacturer's net disposal of such basic class of narcotic drug during the immediately preceding calendar year or the average of the three immediately preceding calendar years in which such manufacturer produced such basic class of narcotic drug, whichever is greater; and

(2) one-half of such manufacturer's net disposal of such basic class of narcotic drug during the immediately preceding calendar year; less such manufacturer's inventory of such basic class of narcotic drug on December 31 of the preceding calendar year.

(d) Provisional quota for licensed manufacturers. During the period from January 1 until a manufacturing quota for such calendar year is fixed pursuant to subsection (c) of this section, any licensed manufacturer entitled to receive a quota for any basic class of narcotic drug under subsection (c) of this section may manufacture a provisional quota of not more than 75 per centum of whichever of the following is greater

(1) such manufacturer's net disposal of such basic class of narcotic drug during the twelve months immediately preceding September 30 of the preceding calendar year; or

(2) twelve times such manufacturer's average monthly net disposal of such basic class of narcotic drug for the thirty-three months immediately preceding September 30 of the preceding calendar year;

or such higher or lower percentage as the Secretary or his delegate may from time to time for good cause direct. Any higher or lower percentage so directed shall apply to the provisional quotas of all licensed manufacturers for such basic class of narcotic drug. (e) Application for quota by licensed manufacturer who has not manufactured basic class of drug during one or more of three preceding years. The Secretary or his delegate shall, on application therefor, and subject to the provisions of subsections (a) and (b) of this section, fix a quota for any licensed manufacturer of a basic class of narcotic drug who has not manufactured such basic class of narcotic drug during one or more of the three immediately preceding calendar years, in an amount adequate to cover such manufacturer's reasonably anticipated requirements for the current calendar year.

(f) Increase of quota; matters considered.

At any time during the calendar year any licensed manufacturer who has applied for or received a manufacturing quota for a basic class of narcotic drug may apply for an increase in such quota, to meet his estimated disposal, inventory, and other requirements during the remainder of such calendar year. In passing upon such application the Secretary or his delegate shall take into consideration any occurrences since the filing of such manufacturer's initial quota application that may require an increased manufacturing rate by such manufacturer during the balance of such calendar year. In passing upon such application the Secretary or his delegate may also take into consideration the amount, if any, by which the determination of the Secretary or his delegate under subsection (a) of this section exceeds the aggregate of the quotas of all manufacturers under this section, and the equitable distribution of such excess among other manufacturers. 86-429, § 11, Apr. 22, 1960, 74 Stat. 64.)

EFFECTIVE DATE

(Pub. L.

Section effective Jan. 1, 1961, see section 22 of Pub. L. 86-429, set out as a note under section 501 of this title.

§ 510. Exception from applicability of license and quota provisions.

Notwithstanding any other provisions of this

chapter

(1) no license or quota shall be required for the manufacture of such quantities of narcotic drugs as incidentally but necessarily result from the manufacturing process used for the manufacture of a basic class of narcotic drug duly licensed under this chapter; and

(2) no license or quota shall be required for the manufacture of such quantities of narcotic drugs as incidentally but necessarily result from the manufacture of any substance which is not a narcotic drug.

Unless such incidentally but necessarily resulting narcotic drug shall have been determined to be nonaddicting by the Secretary or his delegate, it may (apart from being used in the process of producing a narcotic drug for which license and quota are held) be retained or disposed of only in such manner as may be prescribed or authorized by the Secretary or his delegate. (Pub. L. 86-429, § 12, Apr. 22, 1960, 74 Stat. 65.)

REFERENCES IN TEXT

This chapter, referred to in the text, was in the original "this Act", meaning Pub. L. 86-429, which added this chapter and amended section 182 of this title and sections 4702(a) and 4731 (a), (g) of Title 26, Internal Revenue Code of 1954.

EFFECTIVE DATE

The

Section effective Jan. 1, 1961, see section 22 of Pub. L. 86-429, set out as a note under section 501 of this title. § 511. Records and reports by manufacturers of narcotic precursors; report to the Congress. Persons who manufacture, compound, package, sell, deal in, or give away any narcotic precursor shall keep such records and make such reports with respect to such narcotic precursor as the Secretary or his delegate shall by regulation prescribe. Secretary or his delegate may advise the Congress whether in his opinion the manufacture and distribution of narcotic precursors threaten to result in the diversion of narcotic drugs into other than legitimate medical and scientific channels and whether in his judgment further legislation with respect to narcotic precursors is necessary or desirable. (Pub. L. 86-429, § 13, Apr. 22, 1960, 74 Stat. 66.)

EFFECTIVE DATE

Section effective Jan. 1, 1961, see section 22 of Pub. L. 86-429, set out as a note under section 501 of this title. § 512. Judicial review.

Every final decision of the Secretary or his delegate under sections 502(i), 504, 506, 507, 509 (c), 509(e), or 509 (f) of this title shall be subject to judicial review as provided by and in the manner prescribed in sections 1031-1042 of Title 5. (Pub. L. 86-429, § 14, Apr. 22, 1960, 74 Stat. 66.)

EFFECTIVE DATE

Section effective Jan. 1, 1961, see section 22 of Pub. L. 86-429, set out as a note under section 501 of this title. § 513. Authorization by Secretary for importation of narcotic drugs.

Notwithstanding the provisions of this chapter or any other law, the Secretary or his delegate may in his discretion authorize the importation of any narcotic drug or drugs (including crude opium or coca leaves) for delivery to officials of the United Nations, of the Government of the United States, or of any of the several States, or to any person licensed or qualified to be licensed under section 506 of this title, for scientific purposes only. (Pub. L. 86-429, § 16, Apr. 22, 1960, 74 Stat. 67.)

REFERENCES IN TEXT

This chapter, referred to in the text, was in the original "this Act", meaning Pub. L. 86-429, which added this chapter and amended section 182 of this title and sections 4702(a) and 4731 (a), (g) of Title 26, Internal Revenue Code of 1954.

EFFECTIVE DATE

Section effective Jan. 1, 1961, see section 22 of Pub. L. 86-429, set out as a note under section 501 of this title. § 514. Enforcement and authority to delegate functions.

It shall be the duty of the Secretary or his delegate to enforce the provisions of this chapter, and he is authorized to make, prescribe, and publish all necessary rules and regulations for carrying out its