Order on the possession, distribution, dispensing, and administration of the pharmaceutical specialty Mifegyne 200 mg. in tablet form, 28 December 1988.
This French Order has been made having regard to an Order of 22 November 1988 inserting Mifepristone (RU 486) in division II of Schedule A of the Poisons Schedules. The following are among the principal provisions. Division I sets out duties of the manufacturer and wholesale distributors of the pharmaceutical specialty Mifegyne 200 mg in tablet form (Sections 1-5). Under Section 2, pharmaceutical establishments manufacturing or distributing this specialty must keep it in locked cupboards or premises. Under Section 3, every purchase or transfer by a wholesale pharmaceutical establishment, even without charge, must be recorded in a special register, following the procedures indicated. Requirements as to reporting are laid down in Section 4. The register referred to in Section 3 must be retained for 10 years. Division II covers the purchase of the pharmaceutical specialty Mifegyne 200 mg, in tablet form, by establishments performing voluntary terminations of pregnancy, and the dispensing and administration of this specialty (Sections 6-16). Detailed provisions are laid down concerning the procedures to be followed in purchasing, dispensing, etc. the specialty. In particular, a special numbered booklet is to be kept, containing a series of vouchers. The procedures for completing such vouchers and the conditions for their retention are indicated. Under Section 13, pharmacists may supply the specialty only to physicians entitled to prescribe it (and with their names and signatures filed with the pharmacist) or to the person in charge of a department in which voluntary terminations of pregnancy are performed. Section 14 lays down that only physicians performing such terminations are authorized to prescribe and administer this specialty. It is laid down in Section 15 that the pharmacist is to undertake, in the presence of the director of the establishment, a monthly inspection of the cupboard within the department where the specialty is kept.