10 



THE CUBA REVIEW 



NEW PATENT MEDICINE REGULATIONS 



THEIR RIGID CHARACTER FINE AND CONFISCATION FOR NON-OBSER- 

 VANCE SIX MONTHS TIME GIVEN 



The Cuban Department of Health has re- 

 cently promulgated comprehensive regula- 

 tions governing sanitation and the prepara- 

 tion and sale of pharmaceutical compounds. 

 The rigid character of these . regulations, 

 as contained in the decree of April 23, 1913, 

 called forth a request from the National 

 Pharmaceutical Association that more time 

 be given for compliance with then new 

 requirements. This protest resulted in the 

 issuing of a supplementary decree, under 

 date of August 22, 1913, modifying certain 

 clauses in the original decree. Nonobserv- 

 ance of the requirements is punishable by 

 fine and confiscation of the product. An 

 abstract of the regulations relating to pat- 

 ent medicines is given below : 



Art. 40. The term "patent medicine" in- 

 dicates any medicine offered for sale in a 

 uniform container, with printed wrapper 

 and label. 



Patent medicines and serum, vaccine, and 

 similar preparations may be sold only in 

 wholesale or retail drug stores and in the 

 laboratories where prepared. 



Art. 43. When a patent medicine con- 

 tains any of the following substances or 

 their derivatives, the name and quantity of 

 such substance must be shown on the label : 

 Morphine, opium, cocaine, heroin, eucaine 

 (alpha or beta), chloroform, cannabis in- 

 dica, chloral hydrate, acetanihde, strych- 

 nine, and such others as may be designated 

 by the Bureau of Health (Direccion de 

 Sanidad). 



Art. 44. Any false or misleading state- 

 ment as to the composition of a patent 

 medicine, or as to the kinds and amounts 

 of substances contained therein, is abso- 

 lutely prohibited. The Bureau of Health 

 may, at any time, order the analysis of any 

 patent medicine. 



Art. 45. The sale of patent medicines 

 with anonymous label, or with false indi- 

 cation as to manufacturer or factory of 

 origin, is prohibited. 



Art. 46. Foreign patent medicines must 

 be registered with the Bureau of Healthby 

 agents or importers, and their circulation 

 in the country shall be permitted only upon 

 fulfillment of the following conditions: 

 (a) The labels must name the constituents 

 to which the patented article owes its medi- 

 cinal properties; (b) tl labels must also 

 state the name of the n a uf acturing_ drug- 

 gist or company in the coiintry of origin. 



Art. 47. No patent medi'ine shall be put 

 .on sale before its registration with the 

 Bureau of Health. A certificate of regis- 



tration will be issued by the said bureau 

 within three days from date of application. 

 The advertisement or sale of a. medicine 

 intended to prevent conception is prohibited. 

 Art. 48. Branches or agencies of foreign 

 laboratories established in Cuba which 

 manufacture or put up patent medicines 

 shall be in charge of a pharmacist, quali- 

 fied according to article 1, of the law of 

 February 29, 1912, and the products of such 

 laboratories shall bear the name of the 

 pharmaceutical director and the location of 

 the plant. 



Art. 52. No serum, vaccine, toxine, or 

 similar preparation, domestic or foreign, 

 for human or veterinary use, shall be sold 

 or distributed unless authorized by the 

 Bureau of Health. 



The Bureau of Health may, at any time, 

 order investigations and experimental tests, 

 and any of the above preparations not con- 

 forming to requirements shall be confis- 

 cated. 



Art. 56. The products mentioned in 

 article 52 shall be sold in their original 

 packages, with a label showing the name of 

 the laboratory and its management, date of 

 preparation, serial number, and, except in 

 the case of articles not affected by time or 

 climate, period of efficacy. They must be 

 accompanied by instructions for use, show- 

 ing the standard strength, method of pres- 

 ervation, and curative, preventive, or diag- 

 nostic properties. 



Art. 58. The sale of foreign products, 

 shall conform to the above requirements. 

 Agents or representatives of foreign manu- 

 facturers must apply for authority to sell 

 their goods, and must present a legalized 

 consular certificate showing that their 

 manufacturing laboratories operate legally 

 in the country of origin. 



Art. 60. The sale is prohibited of any 

 serum, vaccine, toxine, or similar prepara- 

 tion whose period of efficacy has expired. 



Art. 76. Execution is suspended for two 

 years from the date of this decree [Aug. 22, 

 1913] of the regulation contained in section 

 (o) of article 46, and of that contained in 

 article 52 relating to serum, vaccine, toxine, 

 and similar preparations. 



A period of six months is allowed for 

 reports to be made to the Bureau of Health 

 on all patent medicines on sale and not 

 registered previous to the date of this de- 

 cree. 



Cuba is a large buyer of all kinds of 

 patent medicines. '■ Imports in 1910 were 

 $223,000 and in 1911, $251,000. 



