Key Benefits:
Buenos Aires, November 15, 1968.
VISTO the sanction of Law 17.565 establishing rules for the exercise of the pharmaceutical profession, and
CONSIDERING:
That the Public Health Secretariat has proposed the corresponding regulations,
The President of the Argentine Nation, Decreta:Article 1 . Approve the attached body of statutory provisions of Law 17.565 for the purpose of its application in federal jurisdiction.
Article 2° . Please refer to the Secretariat of State of Public Health to dictate the regulatory, complementary, clarification or interpretative rules that require the application of the regulatory decree adopted by the present.
Article 3 . This decree will be endorsed by the Minister of Social Welfare and signed by the Secretary of State of Public Health.
Article 4° . Communicate; publish, give to the National Directorate of the Official Register and archvese.
Onganía. - Conrado E. Bauer - Ezequiel A. D. Holmberg. LAW REGLAMENT No. 17.565Art. 1 . The pharmacies may annex in addition to the activities established by law, the sale of products intended for the hygiene or aesthetics of persons, as well as those assigned to them prophylactic, disinfectant, insecticid or other similar properties, subject to the control of the State Secretariat for Public Health.
Art. 2° . For the purposes of its implementation in the Federal Capital, National Land of Fire, Antarctica and South Atlantic Islands, of the law that is regulated, the State Secretariat for Public Health shall be competent.
The Secretariat of State of Public Health through its competent agencies shall, in a precarious manner, authorize the installation of pharmacy kits in the National Territory of the Tierra del Fuego, Antarctica and South Atlantic Islands, in accordance with the minimum petitory to be determined, which shall be limited to the sale of medicinal specialities packaged.
It is incompatible the coexistence, in the same town, of pharmacy kits with pharmacies, and the previously agreed permits will expire, in full, at six (6) months of the installation of a pharmacy.
Art. 3° . Any natural or legal person wishing to install a pharmacy must apply to the State Secretariat for Public Health, in compliance with the requirements of the State Secretariat for Health regarding sanitary and safety conditions of the premises, laboratories, installations, equipment, instruments, laboratory elements, drugs, reactants, chemicals, official preparations, serums and vaccines. The following data should be recorded in the application, which is the cause of suspension and/or negativity of the procedure the omission, non-compliance or falseness of the same:
(a) name of the pharmacy;
(b) name or social reason, as required by article 14 of the law and the present regulation;
(c) location of the pharmacy and its legal domicile;
(d) Identification data of the technical director;
(e) Declaration relating to the type and branches of activity to be printed at the establishment.
These requirements are met by the State Secretariat for Public Health shall inspect the premises and facilities and, if appropriate, grant the appropriate qualification.
To pharmacies under installation, expansion and/or reform, the State Secretariat for Public Health may grant partial and/or provisional authorizations for a period not exceeding ninety (90) days, provided that it considers that the minimum conditions required to ensure adequate benefits are met.
The State Secretariat for Public Health shall establish the payroll of medicines or medicinal specialties that pharmacies should be available on a permanent basis.
When the State Secretariat of Public Health intervenes a product or suspends its sale, the pharmacies will be obliged to withdraw it from the sale by denouncing the amount they possess, as well as if they will keep it in stock or choose to return it to the source laboratory, in this case, to refer to the State Secretariat of Public Health photocopy of the corresponding remit.
Art. 4° . No regulation.
Art. 5° . The pharmacies that are also dedicated to preparing recipes according to the homeopathic technique should have a laboratory exclusively for this purpose, isolated from the other units and from the laboratory for the preparation of recipes with alopathic technique; whose characteristics, instrumental, elements and minimum petitory will be fixed by the State Secretariat of Public Health.
Art. 6° : For the purposes of the article that is regulated, see:
(a) Night office in cases of urgency, which is required for pharmacies even if not in turn.
In order to access it, the pharmacist may require the presentation of the prescription in which the need for the perennial administration of the prescribed medication is stated.
b) "turnos", those who must fulfill the pharmacies in addition to their usual schedule of attention to the public.
The State Secretariat for Public Health shall make the list of mandatory pharmacy shifts, establishing the respective calendar days, being empowered to correct all matters of detail that their practical application demands, having to adopt the necessary orders for their most appropriate and wide dissemination.
Art. 7° botella In the signs of bottles, jars, packages, boxes, etc., with which the magisterial formulas are dispatched to the public, the name, name and title of the technical director of the pharmacy must be included; the office must be made in the name of the pharmacy, with indication of the address of the pharmacy, the order number corresponding to the prescription book, name of the doctor and full transcription.
Art. 8° La The State Secretariat for Public Health shall establish the payroll of substances to be retained under the conditions established by the article.
Art. 9° : For the purposes of the article that is regulated, consider:
(a) products of "legally restricted exploitation" those containing narcotic substances (alkaloids) and should a according to the existing legal norms be prescribed in official forms and according to the model approved by the State Secretariat of Public Health;
b) products of "expendium under an archived recipe", those that the State Secretariat of Public Health considers should be dispatched to the public with such requirements and for each package the corresponding recipe must be required, and recipes containing more than one package may be accepted, provided that the professional makes the prescription clearly and accurately.
The recipe must be transcribed in the prescription book, numbered, sealed and signed by the Technical Director of the pharmacy and orderly archived. Análogo procedimiento debe seguir el Director Técnico y/o pharmacist auxiliar con las formulas magistrales que despache, provided that its composition is integrated with those drugs and, you must add taltal as provided by the Secretariat of State of Public Health for products produced in pharmaceutical industrial establishments la to the container the legend "This medicine must be used exclusively under prescription and medical supervision and cannot be repeated without new prescription". Those who do not comply with this requirement shall be charged and those responsible for its elaboration shall be liable to the penalties prescribed by law.
c) products of "expendium under recipe", those that the State Secretariat of Public Health considers . according to the current legal norms que which cannot be discarded to the public without the previous presentation of the recipe.
The Technical Directors and/or auxiliary pharmacists are required to sign, seal and number the recipes containing master and official formulas, responsible for their proper preparation.
The specialties authorized by the State Secretariat for Public Health as a "prescription sale" may be repeatedly dispatched with the same recipe the number of times the doctor has indicated, by obliging the pharmacist at each time to seal, number and sign it.
d) products of "free exploration", those that the State Secretariat of Public Health has authorized with such characteristics.
When the size or content of the container is omitted in the medical recipe, the pharmacist must discard the least content. In the event that a medical specialty has a varied circulation and is not indicated in the medical prescription, the pharmacist is obliged to discard the lowest dose, unless, by personally consulting with the doctor who performed the prescription, the prescription is given different doses. In this case the pharmacist will proceed before dispatching it, to leave handwritten and with his signature the proper record in the recipe.
Art. 10. Los The books referred to in the article to which it is regulated should be brought up to date and be made available and displayed to the inspectors of the State Secretariat for Public Health, at their request.
The recipe copying book must be signed by the Technical Director of the pharmacy daily at the end of the last transcription recipe.
Art. 11. . For the purposes of the article that is regulated, be content by propaganda or advertising that is carried out in sheets, posters, circulars, journalistic or radial notices, televisions or any other means that serve such purposes.
The Secretariat of State of Public Health shall not proceed with any request for authorization of propaganda to be carried out in pharmacies, containing references of a composite nature of medicinal products.
It is excluded from the requirement of prior approval, such propaganda that is limited to announcing the name, address and phone of the pharmacy, the fulfillment of the compulsory shift service and the provision of voluntary night service.
The pharmacies should be announced with the denomination with which they were authorized by the State Secretariat of Public Health, not being able to use encomitorial or superlative terms, or to include with them in error with respect to their nature, or to be attributed as a social work pharmacy, or similar.
Nor can they induce the public to use certain clinical analysis laboratories or receive material for analysis at the pharmacy.
Art. 12. . Pharmacies wishing to provide the service of the application of subcutaneous or intramuscular injections must obtain prior authorization from the competent bodies of the State Secretariat of Public Health, and shall be carried out under the supervision and responsibility of the Technical Director of the same, who shall inform the aforementioned Secretariat of State him or the names of the persons responsible for it.
Injections in pharmacies may be applied by pharmacists and persons authorized by Law 17.132.
The authorized pharmacy is obliged to provide the service within the normal schedule of its tasks.
The application will be done only by express medical indication, that the patient must be accredited previously.
The specifications of the recipe, date of application, name and registration number of the professional who indicated it, name and domicile of the patient; they must be recorded in the book register bound and foliated, and signed by the competent bodies of the State Secretariat of Public Health, with the signature, in each case, of the person who made the application; book that must be brought to the day and made available and displayed to the inspectors of the State Secretariat
If the patient presents a container that does not provide sufficient security assurances, the Technical Director may deny the application.
Art. 13. . No regulation.
Art. 14. . For the purpose of obtaining the authorization to install a pharmacy, the interested parties must submit to the State Secretariat for Public Health the relevant documentation that credits the ownership of the property.
In all cases, the company contracts that form, the purpose of which is the property of a pharmacy, as well as its modifications or assignment of rights, shall:
(a) be formalized by public writing;
(b) To be subject to the prior approval of the State Secretariat for Public Health, which shall record it;
c) be registered with Commercial Justice.
Failure to comply with the above requirements will make them liable to the suspension and/or refusal of the authorization procedure.
Where any of the societies referred to in the article regulating the state of dissolution, such circumstances should be communicated immediately to the State Secretariat for Public Health. This obligation is the responsibility of both partners, whether or not pharmacists, and the legal representatives thereof; but fulfilled by one of them, it will free others from making it. If other legal reasons do not determine the immediate closure of the pharmacy, the pharmacy will indefectably be made to the ninety-nine (90) days of the occurrence of the causes of dissolution that for the societies foresee the existing legal provisions.
Companies referred to in subparagraph (c) of the article that is regulated shall be authorized by the State Secretariat for Public Health for the installation of a pharmacy. In no case will the pharmacists be able to transfer to non- pharmacists the interests or quotas they possess in the society or to associate them to their liquorous or similar part by any means the actual contribution of capital. If the above violations are found, the State Secretariat for Public Health may proceed to the closure of the pharmacy and the disqualification of the pharmacist.
The sole pharmacist owner of a pharmacy must be the Technical Director of the same. When it comes to pharmacists, one of them should be the Technical Director of the pharmacy.
Pharmaceutical companies, regardless of their non-existent species to date, whose corporate form does not conform to the provisions of Law 17.565, shall conform to the provisions of the same within one (1) year.
Art. 15. Las The pharmacies set forth in Article 14 (d) of the Law that is regulated shall be authorized by the State Secretariat of Public Health, it is prohibited to develop in them other activities than the specific ones, which shall be carried out for commercial or profit purposes.
In no case can these pharmacies grant their benefits to persons who do not give their status as affiliates or beneficiaries of the proprietary entity. The State Secretariat for Public Health, regardless of the technical control of its functioning, is empowered to review the books and proof accounting documentation of the property and financial economic development that demand the activity of this type of pharmacies and to issue the regulatory and complementary provisions that are necessary for the most appropriate fulfilment of its purposes.
These pharmacies in no case may be delivered in concession, location or exploited in society with third parties be declared or hidden. When transgression to this rule is verified, the State Secretariat for Public Health shall proceed to the immediate closure of the establishment, without prejudice to any sanctions that may be applied, as appropriate.
Art. 16. . Once the term that agrees to the regulated Article, the right to have the right to transfer the pharmacy or to form a company with a pharmacist, as stipulated in article 14 (c) of Law 17.565 and this regulation. The relevant authority of the State Secretariat for Public Health should be obtained in all cases.
Art. 17. s To register your titles and get the enrollment, interested parties should:
(a) to present the original diploma, qualification or properly legalized;
(b) to present proof of identity;
(c) To register its signature in the State Secretariat for Public Health.
In cases where the competent bodies of the State Secretariat for Public Health believe it appropriate, they may request authenticated photocopy of the original title and obtain the necessary background and checks to the grantor of the title.
Art. 18. . No pharmacist Technical Director of a pharmacy may abandon his or her functions without the technical director taking over them.
Art. 19. . No regulation.
Art. 20. . No regulation.
Art. 21. La The Secretariat of State of Public Health through its competent agencies may authorize, in a precarious manner, the National Territory of the Tierra del Fuego, Antarctica and South Atlantic Islands, pharmacists to perform clinical analyses in laboratories annexed to pharmacies, having to fix the hygienic conditions of the premises and the petitorio itself of instruments, apparatuses, useful of work and reagents that must be periodically endowed.
Authorized pharmacists may perform only physical and chemical analysis.
Art. 22. . The inability referred to in the article that is regulated will be determined by a Medical Board constituted by a doctor appointed by the State Secretariat for Public Health, who will preside over the Board; another designated by the Faculty of Medicine of the University of Buenos Aires, at the request of the State Secretariat for Public Health and another designated by the person concerned. The decisions of the Medical Board will be made by a simple majority of votes.
The Medical Board shall meet, perform the examinations and be issued within ten (10) working days of their integration, a period that for substantial reasons may be extended to twenty (20) days.
The absence of the doctor on the part shall not prevent the role of the Board.
Art. 23. . No regulation.
Art. 24. . Competent medicinal products shall be made available to the State Secretariat of Public Health for the period of one hundred and eighty (180) days from the date on which the measure is final and published, so that third creditors of good faith may assert their rights to the Justice for amounts owed to it, through preventive embargoes and/or any other measure of judicial character that may be made effective in the case of intervened products.
If the time limit of one hundred and eighty (180) days does not involve any measure by third creditors of good faith, medicinal products shall be owned by the Secretariat of State of Public Health.
Art. 25. . They are excluded from the incompatibility that determines the article that is regulated, pharmacists who carry out the technical direction of a pharmacy in official establishments, provided that during the time of performance of these functions, an auxiliary pharmacist is in charge of his private pharmacy, under the conditions set out in the Law that is regulated.
The State Secretariat for Public Health shall not authorize the performance of a pharmacist as a Technical Director of a pharmacy located in the Federal Capital without the person concerned prior accreditation, by certification issued by competent health authority, who does not perform his profession in the jurisdiction of the Province of Buenos Aires.
The Technical Director of the pharmacy is obliged to:
(a) Practice tests and checks aimed at determining the purity of drugs, chemicals and official preparations used in the pharmacy under their direction, and to eliminate those who do not meet that condition;
(b) Preparation of teacher formulas;
(c) To ensure that in the pharmacy under its direction only the prescriptions extended by persons authorized by Law 17.132 are accepted;
(d) Adopt the necessary precautions for the proper conservation of drugs and drugs;
(e) To maintain in the pharmacy under its direction, updated and in conditions, all elements determined by the State Secretariat for Public Health, in accordance with article 3 of this regulation.
Art. 26. . When the Technical Director of the pharmacy is absent, he will close with his signature the prescription book indicating the time in which he does, having to adopt identical requisitions when reintegrating into his functions.
If during these absences the office is in charge of office assistants, it must be displayed on the counter and in the window, a notice indicating that the pharmacist is absent, indicating the time he will return.
The auxiliary pharmacists must present their title at the pharmacy where they are performed, and in case of exercising in more than one pharmacy they must exhibit in a diploma and in the other. The record of their registration issued by the State Secretariat for Public Health, which should be renewed with each change in establishment.
For the purposes of subparagraph (b) of the article that is regulated, they are considered as assistants of office:
(a) Students from the Faculty of Pharmacy and Biochemistry and/or Schools of Pharmacy of Official or Private Universities authorized by the National State, who have approved the basic subjects of their career;
(b) Pharmaceuticals with legalized foreign titles, who have not revalued in the country;
(c) those holding titles granted by Schools recognized by the State Secretariat for Public Health;
(d) The appropriate pharmacy, suitable and pharmacy assistants registered in the State Secretariat for Public Health prior to the enactment of the law that is regulated.
Art. 27. . Please note that the maximum limit for the absences of the Technical Director of a pharmacy is one (1) year. In all cases, the substitute pharmacist shall, with the relevant intervention of the State Secretariat for Public Health, assume the status of Technical Director.
The voluntary closure of the pharmacies may not exceed fifteen (15) days, which period the State Secretariat of Public Health may authorize is extended to thirty (30) days. If you consider the reasons for such a reason to be submitted to you in due course.
During temporary closures, pharmacies will retain the obligation to keep up-to-date the notice of duty shifts, as provided for in Article 6 of the Act.
Art. 28. . No regulation.
Art. 29. . The inspectors of the State Secretariat of Public Health will collect for their analysis, medicinal specialties, drug samples, chemicals, official preparations and prescriptions that are prepared or specially prepared, adopting the precautions that it establishes for the collection of samples.
The analyses will be carried out by the competent agencies of the State Secretariat of Public Health or those others that it determines and its result communicated to the pharmacist who in case of dissatisfaction may request within five (5) days of notified, new analysis, and may require it to be performed in his presence or in that of the professional who designates in his replacement. For this analysis, the witness sample that will have been preserved should be used.
The divergences that might arise in this regard will be submitted to the National Commission of the Argentine Pharmacopea.
Art. 30. . In the preparation of recipes that prescribe organic products, the technical directors of the pharmacies must, at the request of the State Secretariat of Public Health, declare the method of preparation they use and will be responsible for the composition and activity of the same.
Pharmacy Technical Directors are forbidden:
(a) Dispatch teachers who are not in scientific and technical conditions;
(b) have in existence pre-conditional formulas;
c) develop in industrial scale the manufacture of medicinal or cosmetic specialties.
Art. 31.. No regulation.
Art. 32. -- No regulation.
Art. 33. . No regulation.
Art. 34. . Any natural or legal person wishing to install a drugstore must apply for pre-entitlement to the State Secretariat for Public Health, complying with the requirements it establishes in terms of sanitary and safety conditions of the premises, quality control laboratory, instrumental, useful and equipment. The following data should be recorded in the request, and the omission, non-compliance or falseness of the omissions are liable to suspension and/or refusal of the procedure:
(a) name of drugstore;
(b) name or social reason, indicating the data that permits the identification of their owners or in the case of commercial companies, that of their legal representatives and that it is registered with Commercial Justice;
(c) location of the drugstore and its legal domicile;
(d) Identification data of the Technical Director;
(e) Statement relating to the type and branches of activity to be printed at the establishment.
These requirements are met by the State Secretariat for Public Health shall inspect the premises and facilities and, if appropriate, grant the appropriate qualification.
To drugstores through installation, expansion and/or reform, the State Secretariat for Public Health may grant partial and/or provisional qualifications for a period not exceeding ninety (90) days provided that the minimum conditions required to ensure adequate benefits are met.
Once the qualification has been granted, drugstores will not be able to make any modification in their denomination and/or social reason, in the establishment, or to incorporate new processing, production or fractionation activities, without prior authorization from the State Secretariat for Public Health.
Drugstores are obliged to have permanent existence of drugs and pharmaceutical specialties necessary for the normal functioning of pharmacies.
When the State Secretariat for Public Health intervenes or suspends its sale, the drugstores will be obliged to remove it from the sale by deducting the amount they possess, as well as if they will keep it in stock or opt to return it to the laboratory of origin, in this case, referring to the State Secretariat for Public Health, photocopy of the corresponding remit.
Representatives of foreign firms producing products authorized for sale in the country may establish deposits of such products for the sole purpose of their distribution and wholesale sale, and must apply for the prior authorization of the State Secretariat for Public Health, which shall establish the requirements and may agree with that exclusive purpose. The representative may make only administrative and/or commercial arrangements, and the handling of the products by a technical director pharmacist should remain.
The holders of the drugstores and deposits and the technical directors shall inform the Secretariat of State of Public Health, any modification in the technical direction, for the purpose of obtaining the corresponding authorization.
No Technical Director of a drugstore may abandon his or her functions without the replacement of such functions by the Technical Director.
Art. 35. . Without prejudice to the obligations established by the law that is regulated, the Technical Director of the drugstore shall remain in the establishment and direct personally and under his responsibility the tasks inherent in the fractionation of drugs and/or preparation of medicines or official preparations.
Art. 36. . The sale by drugstores of medicinal specialties, drugs and medicines can only be made to pharmacies, hospitals, laboratories and persons authorized for use; possession or sale, having to comply with the precautions established by the State Secretariat for Public Health.
The acquisition and sale made by the drugstores of products of "sub-prescription filed" shall be made by invoice and/or sender separated from other lines, having the documentation kept in an orderly manner and be displayed and made available to the inspectors of the State Secretariat of Public Health, to their requirement.
The documentation shall be retained for a period not less than two (2) years, after which they may be destroyed, after communication with the State Secretariat for Public Health.
Art. 37. El The Technical Director of the drugstore will be responsible for the purity and legitimacy of the drugs it fractions and the drugs it produces. As for medicinal specialties, their responsibility will be limited to their legitimacy, provenance and conservation.
When the drug or medicine is marketed without modification of the original packaging, the responsibility for its quality will be of the manufacturer or fraction of which will be exempt only when it is verified that it has been maintained in poor conditions of conservation or in contravention with the labelling specifications.
The inspectors of the State Secretariat of Public Health will collect for their analysis samples of the medicinal specialties, drugs that are in existence or of drugs that produce drugstores, adopting the precautions that it establishes for the collection of samples.
The analyses will be carried out by the competent agencies of the State Secretariat of Public Health or those others that it determines and its result communicated to the Technical Director of the drugstore, who in case of dissatisfaction may request within five (5) days of notified, new analysis, may require it to be carried out in his presence or in that of the professional who designates in his replacement. For this analysis, the witness sample that will have been preserved should be used.
The divergences that might arise in this regard will be submitted to the National Commission of the Argentine Pharmacopea.
Art. 38. s Without prejudice to the provisions of the article regulating the technical directors of drugstores, they are obliged to label the drugs that fractionate with the following records:
(a) Scientific name of the drug;
(b) synonym, if any;
(c) origin;
(d) name of the manufacturer;
(e) Number of fractionation and/or processing;
(f) due date, if any;
g) characteristic of purity, according to the Farmacopea Argentina. If it does not appear in this, consign to which Farmacopea responds or to which authorization certificate;
(h) Number of analysis protocols;
(i) Net weight or net volume of the drug;
(j) indication of toxicity or hazardous use and indications to follow in cases of poisoning;
(k) indication of the way or means of preserving the drug so that it does not suffer alterations;
(l) name and address of the drugstore;
(m) name of the Technical Director.
Pharmaceutical drugs should be adjusted for your
quality to the norms of the Farmacopea Argentina. In the case of an uncodified drug in this drug, it must be adjusted to the source pharmacopee and, if it were a new drug, it must be previously authorized to use and commercialize it by the State Secretariat for Public Health.
Checking the lack of quality of the drug according to the specifications of its labeling will make them liable for confiscation, without prejudice to the other penalties to be applied.
Art. 39. . No regulation.
Art. 40. Los The books referred to in the article that is regulated will be enabled by the State Secretariat of Public Health by completing the requirements established by the State Secretariat and in all cases the data provided therein must be supported by the signature of the Technical Director of the drugstore.
Art. 41. . Any natural or legal person wishing to install a herbalistry must apply for pre-qualification to the State Secretariat for Public Health, in compliance with the requirements of the State Secretariat for Health and Safety of the premises for deposit and fractionation. The following data should be recorded in the applications, and the omission, non-compliance or falseness of the omissions must be suspended and/or denied the procedure:
(a) Name of the herbalist;
(b) name or social reason, indicating the data that permits the identification of their owners or in the case of commercial companies of their legal representatives and that they are registered with the Commercial Justice;
(c) location of the herboristery and its legal domicile;
(d) Identification data of the Technical Director.
Complied with these requirements, the State Secretariat for Health
The premises and facilities shall be inspected by the public and, if appropriate, granted the appropriate qualification.
In the process of installation, expansion and/or reform, the State Secretariat for Public Health may grant partial and/or provisional qualifications for a period not exceeding 90 (90) days, provided that it considers that the minimum conditions required to ensure adequate benefits are met.
Once the qualification has been granted, herbalists will not be able to make any modification in their denomination and/or social reason, in the establishment, or to incorporate new activities, without prior authorization from the State Secretariat for Public Health.
Herbalists are obliged to have permanent existence of medicinal herbs in quantity that justify their wholesale character.
The holders of the herbalists and the technical directors shall inform the Secretariat of State of Public Health of any modification in the technical direction, in order to obtain the corresponding authorization.
Art. 42. El The Technical Director of the herbalistry will be responsible for the purity and legitimacy of the herbs that fraction or expose, having to remain in the establishment and personally and under his responsibility, the tasks inherent in the fractionation of the herbs.
Without prejudice to the provisions of the article regulating it, the technical directors of the herboristeries are obliged to label the herbs that break or expose, with the following records:
(a) The name, in the national language, of the yerba, may add the scientific denomination thereof;
(b) synonym, if any;
(c) origin;
(d) Net weight of the yerba;
(e) indication of the way or means of keeping the mob so that it does not suffer alterations;
(f) indication of toxicity or hazardous use and indications to follow in case of poisoning, if the nature of the herb warrants it;
(g) name and address of the herbalistry;
(h) Name of the Technical Director.
Any key marking or consigning uses, therapeutic indications or doses is prohibited.
The verification of the lack of quality or legitimacy of the yerba according to the specifications of its label will make them liable for confiscation, without prejudice to the other penalties to be applied.
Herboristeries are forbidden to produce prepared with mixtures of medicinal herbs.
Art. 43. . No regulation.
Art. 44. El The book referred to in the article to which it is regulated will be enabled by the State Secretariat for Public Health, completing the requirements established by the State Secretariat and, in all cases, the data contained therein must be supported by the signature of the Technical Director of the Herbalistry.
The inspectors of the State Secretariat of Public Health will collect for their analysis, samples of the herbs in existence, taking the precautions that it establishes for the collection of the samples.
The analyses will be carried out by the competent agencies of the State Secretariat of Public Health or those others that it determines and its result communicated to the Technical Director of the herbalist, who in case of dissatisfaction may request within five (5) days of notified, new analysis, may require it to be carried out in his presence or in that of the professional who designates in his replacement. For this analysis, the witness sample that will have been preserved should be used.
Art. 45. . No regulation.
Art. 46. . No regulation.
Art. 47. . No regulation.
Art. 48. . No regulation.
Art. 49. . No regulation.
Art. 50. . No regulation.
Art. 51. . No regulation.
Art. 52. . No regulation.
Art. 53. . No regulation.
Art. 54. . No regulation.
Art. 55. . No regulation.
Art. 56. . No regulation.
Art. 57. . No regulation.
Art. 58. . No regulation.
