#2007-157Decree No. 2007-157 on Poisonous Substances and Amendments to the Public Health Code
AI-generated summary for informational purposes only. Not legal advice. See the original source for the authoritative text.
This law updates the regulations concerning poisonous substances in France, focusing on the handling and management of these substances by pharmacists and in public health settings. It mandates detailed record-keeping for any preparations involving these substances, ensuring data accuracy and integrity. Pharmacists must now offer consultation advice and refer patients to doctors if symptoms persist.
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Key Changes
- Pharmacists must record detailed information for prepared substances.
- New regulations mandate pharmacist involvement in administrative decisions.
- Strict record-keeping requirements for the management of toxic substances.
Obligations
What this law requires
Pharmacists must provide a cautionary message, refer patients to pharmacist consultation, and advise consultation with a doctor if symptoms persist on all poisonous substance preparations
Pharmacists must immediately record or transcribe every magistral or officinal preparation in a register or appropriate electronic system with sequential order numbers and specified details (date, prescriber/patient information, complete qualitative and quantitative composition with lot numbers, quantity, and person identification)
Recording systems for preparations must not allow any modification of data after validation and must be duplicated on two separate supports (one for consultation, one as backup) with guaranteed durability and integrity
Authorized persons must immediately record prescriptions or orders for List I, List II, and narcotic classified medications in a register or electronic system with no blanks, corrections, or post-validation modifications allowed
Medication records and registrations must be retained for ten years and made available to control authorities upon request, with capability to print on paper and classify by patient, medication, and chronological order