By: Andrea Castillo
Following sanitary registrations cancellation of products with oral ranitidine, was announced in the Communiqué Jef.DRCPFA-01-2023, the Department of Regulation and Control of Pharmaceutical and Related Products of Guatemala, published on January 31, 2023, the guidelines for the withdrawal of these products. It is important to mention that the information applies to both governmental and non-governmental institutions.
General Guidelines
- It is emphasized that, as of February 28, 2023, the sanitary registrations of pharmaceutical products containing ranitidine by oral route will be canceled in their entirety.
- The cancellation and withdrawal of all sanitary registrations of drugs containing ranitidine by oral route, including the pharmaceutical forms: capsules, tablets, dragees, tablets, suspensions, and oral solutions, will be carried out.
- Public and private establishments will carry out the steps for the withdrawal according to their procedures, the deadline to complete it will be until July 31, 2023 at the latest.
- Ranitidine in injectable solution will remain in force, with exclusive use for private and public hospitals. The Regulatory Authority will evaluate the risk-benefit of the same.
Guidelines for Drugstores and Pharmacies:
- Drugstores and pharmacies will not be allowed to import, distribute, or commercialize ranitidine oral products as of March 1, 2023.
- Additionally, as of May 1, 2023, pharmacies must not commercialize products containing injectable ranitidine.
Finally, a careful reminder is made to consult about therapeutic alternatives that can be used instead of ranitidine, in order to prioritize the health of patients.