Modification of Pharmaceutical Activity Regulation established by Law 13.021/2014
On August 08, 2014, Law 13.021 was enacted, and it's enactment was published on August 11, 2014 on the Official Gazette of the Federal Executive, which transforms the pharmacy in an Health Establishment, establishes the activities which define what is meant by "pharmaceutical assistance", and reiterates the obligation to have a permanent pharmacist in premises, to be in operation.
Law 13.021/2014 defines pharmacy as a "providing services establishment dedicated to provide pharmaceutical assistance, health assistance and individual and collective sanitary orientation" The establishments will now be classified as "pharmacy without drug manipulation or drugstore" and "manipulation pharmacy". In the previous legislation (art. 4, X and XI of Law 5.991/1973) the difference in classification was only relative to the definition of "pharmacy" and "drugstore".
Furthermore, it is now required for pharmacies, with exception of those pharmacies characterized in accordance with the law as Micro and small enterprises, to operate in the permanent presence of a pharmacist, technically qualified in the form of the law (Articles 15 and 16 of Law 3.820/1960), during the entire period of operation of the establishment.
For pharmacies duly recognized as micro and small enterprises, in accordance with the Law, the previous legislation (Art. 15 of Law 5.991/1973) remains valid, which stipulates only the mandatory presence of a "responsible technician registered on the Regional Pharmacy Council" and permits, in certain situations, the replacement of such professional by a "pharmacy technician" (pr?tico de farm?cia) or a "pharmacy official" (oficial de farm?cia). Such exception rule was inserted in the Art. 6 of Law 13.021/2014 by means of the Provisional Measure 653, dated August 8, 2014, published on Official Gazette of the Federal Executive, on August 11, 2014.
Law 13.021/2014 reiterated the provision contained in Law 5.991/1973, as well as on Resolution of the CFF 597 of April 24, 2014, when stipulating that the operation of a pharmacy and drugstore without a professional pharmacist will only be allowed for a maximum period of up to thirty days. In that period, no magisterial or official formulas can be sold, nor medicines that are subject to a special control regime can be sold.
The new Law does not address the limit of the number of pharmacies that can be supervised by a sole pharmacist, remaining in force the provision contained in Law 5.991/1973, which limited for each pharmacist the permission to give technical direction to up to two pharmacies only, being one a commercial one and the other an hospital one (Art. 20).
The new regulations for the operation of pharmacies will take effect in 45 (forty five days), ensuring that the sector may be able to adapt to the new Law.