The drugs and cosmetics act and rules the drugs and cosmetics act, 1940 as amended by the drugs amendment act, 1955, the drugs amendment act, 1960. Short title, extent and commencement1 this act may be called the drugs 1 and cosmetics act, 1940. This guidance document is being distributed for comment purposes only. Federal food, drug, and cosmetic act hereinafter revised draft guidance. Act of june 25, 1938 federal food, drug, and cosmetic act. Food and drug administration fda to oversee the safety of food, drugs, medical devices, and cosmetics. For an official copy of the statute please contact the pennsylvania legislative reference bureau. An act to regulate the import, manufacture, distribution and sale of drugs 2 and cosmetics whereas it is expedient to regulate the 3 import, manufacture, distribution and sale of drugs 2 and cosmetics. Pharmacy compounding of human drug products under section.
Power of central government to prohibit manufacture etc. The drugs act, as enacted in1940, has since been amended several times and is now titled as the drugs and cosmetics act, 1940. The revised draft guidance, which is part of the fdas. An act to regulate the import, manufacture, distribution and sale of drugs 2and cosmetics. The drugs and cosmetics act, 1940 23 of 19401 10th april, 1940 passed by the indian legislature received the assent of the governor general on the 10th april, 1940 as amended by act no. Whereas it is expedient to regulate the 3import, manufacture, distribution and sale of drugs 2and.
Federal food, drug, and cosmetic act as amended through december 31, 2004 see note below chapter ishort title chapter iidefinitions chapter iiiprohibited acts and penalties chapter ivfood chapter vdrugs and devices. Act of june 25, 1938 federal food, drug, and cosmetic act, public law 75717, 52 stat 1040, which prohibited the movement in interstate commerce of adulterated and misbranded food, drugs, devices, and cosmetics, 6251938. The act has been further amended as drugs amendment act 1964 of 1964 to include ayurvedic and unani drugs. This act also governed the import of the drugs in the country. The act prohibits the manufacture of substandard or spurious drug in the country. An act to regulate import, manufacture, distribution and sale of drugs and cosmetics. Drugs and cosmetics amendment act, 2008 salient features of the act. An act to control the advertisement of drugs in certain cases, to prohibit the advertisement for certain purposes of remedies alleged to possess magic qualities and to provide for matters connected therewith. Page 141 title 21food and drugs taining a new animal drug. The drugs and cosmetic act, 1940 was passed in british india to regulate the manufacture, distribution, and sale of drugs in the colony. Act, 1964, the drugs and cosmetics amendments act, 1972, the drugs and.
An act to regulate the import, manufacture, distribution and sale of drugs. The drugs and cosmetics rules, 1945 are the set of rules under the drugs and cosmetics. Further reading drugs and cosmetics rules, 1945 pdf. And whereas the legislatures of all the provinces have passed resolutions in terms of section 103 of the government of india act, 1935, in relation to such of the abovementioned. The fees to be paid by a person submitting to the government analyst under section. Code chapter 9 federal food, drug, and cosmetic act. Ministry of health and family welfare department of health. Subchapter ishort title section 301 subchapter iidefinitions 321 321d subchapter iiiprohibited acts and penalties 331 337a subchapter ivfood 341 350l1 subchapter vdrugs and devices 351 360fff7. Select legal issues congressional research service 2 for safety. Whereas it is expedient to regulate the 3import, manufacture, distribution and sale of drugs 2and cosmetics.
Cosmetic manufacturers are responsible for ensuring that products comply with the law before they are marketed. The drugs and magic remedies objectionable advertisements. And whereas the legislatures of all the provinces have passed resolutions in terms of. Federal act means the federal food, drug, and cosmetic act, as amended 21 u. And whereas the legislatures of all the provinces have passed resolutions in terms of section 103 of the government of india act, 1935, in relation to such of the above. The fdas online reference edition of the federal food, drug and cosmetic act is based on the. Get details on the drugs and cosmetics amendment act, 2008 which includes amendments in the drugs and cosmetics act, 1940. Federal food, drug, and cosmetic act as amended through p. Powers of central government to regulate, restrict or prohibit manufacture, etc. The drugs control act, 1950 an act to provide for the control of the sale, supply and distribution of drugs. The drugs and cosmetics rules, 1945 dadra and nagar haveli. Full text of the federal food, drug, and cosmetic act enforced by the u.
The drugs and cosmetics act, 1940 act 23 of 1940 as amended up to act 26 of 2008 10th april, 1940 an act to regulate the import, manufacture, distribution and sale of drugs and cosmetics. This act may be cited as the federal food, drug, and cosmetic act. Commonwealth of pennsylvania pennsylvania department. This act shall be known and may be cited as the controlled substance, drug, device and cosmetic act. Page 141 title 21food and drugs taining a new animal. Interpretation in this act, except where the context otherwise requires advertisement includes any representation by any means whatsoever. The drugs and cosmetics act, 1940 is an act of the parliament of india which regulates the import, manufacture and distribution of drugs in india. Commonwealth of pennsylvania the controlled substances, drugs, device, and cosmetic act act of 1972, p.
An act to regulate the import, manufacture, distribution and sale of drugs and cosmetics whereas it is expedient to regulate the import, manufacture, distribution and sale of drugs and cosmetics. Purchaser of drug or cosmetic enabled to obtain test or analysis. Section 107c of such public law concerned the applicability of the amendments, and is included in the appendix to this compilation. Through the hatchwaxman act, congress created a carefully balanced regulatory framework facilitating the introduction of lowercost generic drugs while preserving incentives for innovation. The law for the time being in force relating to sea customs and to goods, the import of which is prohibited by section 18 of the sea customs act, 1878 8 of 18781 shall, subject to the provisions of section of this act, apply in respect of drugs 2and cosmetics the import of which is prohibited under this chapter, and officers of customs.
The act regulates the import of drugs in india, so that no substandard or spurious drug will enter into our country. Importation of certain fdaapproved human prescription. If product contains a substance specified in schedule h be labelled with the symbol rx and conspicuously displayed on the left top corner of the label and be also labelled with the following words in red color. The federal food, drug, and cosmetic act and subsequent amending statutes are codified into title 21 chapter 9 of the united states code. The drugs and cosmetics act 1940 with 2005 amendments. A astrology joint director, drugs control administration. Persons bound to disclose place where drugs or cosmetics are manufactured or kept. The drugs specified in schedule d shall be exempt from the provisions of chapter iii of the act and of the rules made thereunder to the extent, and subject to the conditions specified in that schedule. Short title this act may be cited as the food, drugs and chemical substances act. The controlled substances, drugs, device, and cosmetic act. Power of central government to prohibit manufacture, etc.
Drugs and cosmetics amendment act 2008 national portal. The hatchwaxman act provides, among other things, a mechanism for accelerated approval of generic drugs through an abbreviated new drug application. The drugs and cosmetics act, 1940 23 of 19401 10th april, 1940 passed by the indian legislature. Drugs and cosmetics act,1940 and rules, 1945 as amended up to the 31st december, 2016. Schedule x describes the habit forming and narcotics drugs list. The drugs and cosmetics amendment act, 2008 sjtpc 4. The controlled substance, drug, device and cosmetic act act of 1972, p. Schedule h includes drugs that shall be sold by retailer on prescription of the registered medical practitioners. In this act, unless there is anything repugnant in the subject or context, 7 a. Whereas it is expedient to regulate the import, manufacture, distribution and sale of drugs and cosmetics.
Full text containing the act, drugs and cosmetics act, 1940, with all the sections, schedules, short title, enactment date, and footnotes. Be it enacted by parliament in the sixtyfourth year of the republic of india as follows. The person dispensing a prescription containing a drug specified in schedule h and schedule h1 and schedule x shall comply with the following requirements in addition to other requirement of these rules the prescription must not be dispensed more than once unless the prescriber has. Corresponding enhancement in punishment for repeated offenders. Drugs and cosmetics act national health portal of india. Drugs and cosmetics act, 1940 bare acts law library. The drugs and cosmetics amendment bill, 20 a bill further to amend the drugs and cosmetics act, 1940. The primary objective of the act is to ensure that the drugs and cosmetics sold in india are safe, effective and conform to state quality standards. Whereas it is expedient to regulate the 3 import, manufacture, distribution and sale of drugs 2 and cosmetics and whereas the legislatures of all the provinces have passed resolutions in terms of section 103 of the government of india act, 1935, in relation to such of the abovementioned matters and matters ancillary thereto as are. Cognizance can be taken on the complaint of any gazetted officer.
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