تشريعات الصيدلة - المحاضرة 4

Pharmacy Legislations - Lecture 4

• Course Content Overview:

  • Part I: Pharmacist-patient relationship, patient rights & responsibilities, ethical principles, and moral rules (pages 15, 24, 32).
  • Part II: Pharmacy law, legal principles for controlled/non-controlled prescriptions, FDA investigation of new drugs (INDs) pathways (regulatory affairs), and FDA offices (pages 45, 46, 51, 60).
  • Part III: Regulations for pharmacy practice, specific regulations for different types of pharmacies, drug control and trafficking, regulations for substances affecting mental health (pages 65, 67, 71, 74, 75, 80).

• Staff Members:

  • Dr. Walaa E. Abd El Hady (Lecturer of Pharmaceutics)
  • Dr. Ghada Ahmed El-Emam (Lecturer of Pharmaceutics)
  • Dr./Randa Hanie Awadeen (Lecturer of Pharmaceutics)

• General Pharmacy Regulations:

  • Pharmacy licenses cannot be transferred to heirs beyond 10 years from the death of the owner without a sale.
  • No pharmacies can sell drugs or medicinal products in bulk quantities to other pharmacies or hospitals/clinics, except in cases where the products were registered under the owner's name.
  • Medical prescriptions must be issued by licensed human, veterinary, or dental physicians in Egypt.
  • Each drug prepared in a pharmacy must have a label containing the pharmacy's name, address, owner's name, registration number, drug name, preparation date, and usage instructions.
  • Pharmacy records must be maintained for five years.
  • Pharmacy operating hours as well as holidays are determined by health ministers, with consultation with the pharmacy syndicate, aiming for a minimum of 8 hours per day.

• Classification of Pharmacies:

  • Public pharmacies.
  • Private pharmacies, with two sub-types (those affiliated with hospitals and those belonging to cooperatives).
  • Criteria for pharmacy license permits and conditions of operation are specified.

• Importation of Drugs & Medications:

  • Importers must conform to relevant regulations set by the Ministry of Health to bring medications into Egypt.
  • Medications must be accompanied by complete documentation, with proper labeling that indicates the product's name and country of origin.
  • Perishable items like vaccines must be stored in climate-controlled environments.

• Prohibited Actions & Penalties:

  • Engaging in the practice of pharmacy without a license or obtaining a license through fraudulent means.
  • Setting up a pharmacy without the necessary licenses.
  • Administering practices other than those licensed to the pharmacy.
  • Related fines and penalties for breaches are outlined.

• Quiz Information:

  • Content for a quiz about pharmacy regulations is presented.

Additional Notes

• Specific laws/regulations within the slides are detailed for each type of pharmacy (public, private, hospital-affiliated, cooperative).
• The slides also cover aspects of importing, storing, and handling narcotics.
• The presentation touches on penalties for violations.
• Procedures relating to patient care, including prescriptions, and handling controlled substances are discussed.