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RDC No. 430 – Legislation Updates

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We have been following the news about the importance of storing and distributing vaccines and any type of medicine whether it is refrigerated or not. Before the pandemic, this knowledge mainly affected pharmacists, physicians, nurses, researchers and other health professionals and rarely came to the users' attention, except for those who were guided by health professionals but now is common interested for all.

There were important updates to be considered by all interested, on the Resolution of the Collegiate Board – RDC No. 430 – which provides for good practices in the storage, distribution and transport of medicines, which has entered into force since its publication in the D.O.U. on October 9, 2020.

This resolution repeals RDC No. 304 and its complement, RDC No. 360.

The definition of return was included in RDC no. 430, as article XXXI of Art. 3: "return: return to the supplier of the drugs physically incorporated to the customer's stock and, thus, entered the chain of custody of the customer. These medicinal products, when returned to their origin, are with a tax document or corresponding document, other than the shipping document";

It was also amended paragraph 2 of Art. 64 which says: "The mandatory temperature monitoring may be exempt ed when the maximum transport time is proven in the records as less than 8 (eight) hours – before that time was 4 (hours) – this is carried out at the end point of dispensing the drug and thermal packaging is used that have a qualification  consistent with the time and conditions of transport".

Do you want to know if you are in compliance with RDC no. 430? Contact us !

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