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  • Title: [Order of 10 September 1992 on the possession, distribution, dispensing, and administration of the pharmaceutical speciality Mifegyne 200 mg. in tablet form].
    Author: France.
    Journal: J Off Repub Fr Ed Lois Decrets; 1992 Sep 20; ():13040-1. PubMed ID: 12222397.
    Abstract:
    This Order sets forth rules on the proper management of Mifegyne (RU 486) in France. Under its first section, manufacturers and distributors are required to keep the drug in a locked cabinet and maintain detailed records of the amounts manufactured and the persons who have sold and bought the drug. Under its second section, the purchase, dispensing, and administration of the drug are restricted to public-sector health establishments and private-sector health establishments authorized under Article L. 176 of the Public Health Code. Such establishments must be authorized to perform voluntary terminations of pregnancy and must own a pharmacy that has been opened under the conditions set forth in Article L. 577 of the Public Health Code and is operated by a pharmacist registered under section D, E, or F of the Public Health Code. The drug must be kept in a locked cabinet by the pharmacy, except for the amounts used weekly, which can be kept under lock in the department where they are used; records must be maintained of purchases and distributions of the drug and of its use, including the signature of any woman desiring to use the drug to terminate her pregnancy; and only specially authorized physicians can prescribe or administer the drug. An Order of 25 November 1992 establishes an automated processing system to enable information to be provided to Parliament on the sociodemographic aspects of voluntary termination of pregnancy and to give the Government, within the framework of its public health policy, the means of elucidating the medical and social reality of this procedure. See Journal Officiel de la Republique Francaise, No. 283, 5 December 1992, p. 16666, as summarized in International Digest of Health Legislation, Vol. 44, No. 2, 1993, p. 351.
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