Ley 208 del 2007

(No. 208)

(Approved December 14, 2007)

AN ACT

To amend subsection

(a) (1) of Section 5.06; and amend subsection

(b) of Section 5.07 of Act No. 247 of September 3, 2004, better known as the "Puerto Rico Pharmacy Act," in order to add as staffing requirement that companies that manufacture, package and/or distribute oxygen and any other medical gas may select either a licensed pharmacist or a certified chemist.

STATEMENT OF MOTIVES

For decades, the industry of manufacturing and distribution of oxygen and other medical gases has been operating in Puerto Rico, serving our hospitals, health centers, medical and veterinary offices, clinical laboratories, retirement homes, industries, businesses, and the community in general in an efficient and safe manner. Medical gases are any liquid or vaporized gas, by itself or mixed with other gases, which are considered to be a drug or medication under the "Puerto Rico Pharmacy Act." Among such gases are, for example, oxygen, helium, nitrogen, carbon dioxide, nitrous oxide, and other gases.

This Legislature deems that whether the requirement of having licensed pharmacists in the operations of prescription medication manufacturing and distribution was also applicable to the industry of manufacturing, packaging and distribution of oxygen and other medical gases was not specifically evaluated in the drafting of the old "Pharmacy Act of 1945," as well as in the new "Pharmacy Act of 2004." It must be recognized that, although medical gases are a segment of

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the medications industry, in some aspects said gases should not be considered to be similar to conventional medications and/or drugs.

The Legislature also deems that enterprises engaged in the manufacturing and distribution of oxygen and other medical gases are already highly regulated by the United States Food & Drug Administration (FDA) and the United States Department of Transportation, which requires strict compliance with the requirements for packaging, signs and labels for containers and cylinders, as well as transport vehicles. Since 1981, the FDA has published guidelines on the good manufacturing practices of medical gases (known as the Current Good Manufacturing Practice for Medical Gases or CGMP). These guidelines have in turn been amended in 1983 and 1989, and since 2003, the adoption of additional amendments is expected, which the FDA is currently evaluating with the collaboration of the industry and the regulated community. In the personnel qualification requirements of the FDA guidelines for the medical gases manufacturing industry, no specific reference is made to the contracting of licensed pharmacists, nor is it demanded.

Neither has it been found that the most recent version of the Model State Pharmacy Act and Model Rules of June 2003, issued by the United States National Association of Boards of Pharmacy, requires the presence of pharmacists in the manufacturing and distribution of medical gases. Information received from numerous Pharmacy Boards from different jurisdictions in the United States consistently reveals that the use of licensed pharmacists is not required for the manufacturing, packaging, and/or distribution of medical gases. In the jurisdictions that deal more strictly, that responded to the consultation, the option of selecting either chemists, or licensed pharmacists, or any other person with several years of experience according to qualification by technical, scientific, practical or

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educational training in the operations of manufacturing, packaging and distribution of medications is provided.

In Puerto Rico, as in the United States, there are enterprises devoted to simultaneously manufacturing and distributing these medical gases, and there are others that limit themselves to purchasing the product to distribute it later. The practice limits itself in part to compliance with strict quality control processes in the production and delivery, whether by cylinders and other containers or by tank trailers to fill the storage tanks located at different hospitals, health centers, retirement homes, industrial facilities and other facilities and businesses, so that said entities consume, use and/or administer the product according to their needs and medical orders. These enterprises are not involved in any phase of the administration and prescription of the dosages or necessary uses, but rather supply the gases according to the purchase orders of their clients.

This Legislature upholds the position that the presence of licensed pharmacists in the manufacturing operations of oxygen and other medical gases is neither essential nor critical in view of the fact that the process is highly automated and has quality and engineering controls. The standard operating procedures and technology established by the experts of these enterprises, which have been implemented for decades, have never needed or required the presence of licensed pharmacists. The industry, however, clearly understands that this does not mean that licensed pharmacists or any other professional may be ruled out when making considerations for employee selection. In fact, some companies in the industry already have chemists, pharmacists and other professionals in their operations. However, the hiring of these professionals has been discretional, according to the needs of each facility and the availability in the markets of professionals willing to work in this industry.

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The history of the medical gases industry in Puerto Rico shows that operations have been conducted in a manner that is efficient and safe for the public. This leads us to emphasizing that the intention of the Government of the Commonwealth of Puerto Rico is that the manufacturing and distribution enterprises, as much as those dedicated to administering and using medical gases, do so in a safe manner, following the best practice recommendations adopted by the industry and the regulating agencies.

Therefore, in spite of the flexibility existing in most United States jurisdictions in which licensed pharmacists are not required in the medical gases industry, this Legislature deems it prudent to establish that as a staffing requirement, companies that manufacture, package and/or distribute oxygen and any other medical gas may select either an authorized pharmacist or a certified chemist.

BE IT ENACTED BY THE LEGISLATURE OF PUERTO RICO:

Section 1.-Subsection

(a) of Section 5.06 of Act No. 247 of September 3, 2004, is hereby amended to read as follows: "Section 5.06.- Pharmaceutical Industry

(a) Any industry engaged in the manufacture of medications shall hold a license from the Secretary which authorizes it to manufacture, market and distribute the same in Puerto Rico. It shall also meet the following requirements:

1. It shall have one (1) or more pharmacists who shall participate in the multidisciplinary team which ensures compliance with the provisions of laws and regulations of the Department of Health and other government agencies concerning the manufacture, packaging and distribution of medications in Puerto Rico, except for enterprises that are engage in the manufacturing, packaging and distribution of oxygen and any other medical gas, in which case, as a staffing requirement, these may select either an authorized pharmacist or a chemist. The industry shall give the Department of the Health notice of

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the identification of the head pharmacist regardless of the number of pharmacists working on its multidisciplinary team. 2. It shall pay the fees established by this Act for the operation of a pharmaceutical industry." Section 2.- Subsection

(b) of Section 5.07 of Act No. 247 of September 3, 2004, is hereby amended to read as follows: "Section 5.07.- Wholesale Distribution

(a) All wholesaler drugstores, wholesale prescription medication distributors, wholesale nonprescription medication distributors, and wholesale veterinary medication distributors shall apply to and obtain from the Secretary a license authorizing them to conduct their corresponding activity in Puerto Rico.

(b) Wholesale prescription medication distributors and wholesaler drugstores shall have the professional services of at least one (1) pharmacist to oversee controls in the distribution of medications. Oversight shall be understood to be the intervention of the pharmacist in the development, revision, approval, and maintenance of standard operating procedures in connection with storage and distribution of medications as determined by the Secretary by regulation. One of the pharmacists shall be the head pharmacist. In the case of those enterprises engaged exclusively in the wholesale distribution of oxygen and any other medical gas, these may select as a staffing requirement either an authorized pharmacist or a certified chemist.

(c) (d)

(e) (f)

Section 3.- This Act shall take effect immediately after its approval.

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CERTIFICATION

I hereby certify to the Secretary of State that the following Act No. 208 (H.B. 4089) of the $6^{ ext {th }}$. Session of the $15^{ ext {th }}$ Legislature of Puerto Rico:

AN ACT to amend subsection

(a) (1) of Section 5.06; and amend subsection

(b) of Section 5.07 of Act No. 247 of September 3, 2004, better known as the "Puerto Rico Pharmacy Act," in order to add as staffing requirement that companies that manufacture, package and/or distribute oxygen and any other medical gas may select either a licensed pharmacist or a certified chemist, has been translated from Spanish to English and that the English version is correct.

In San Juan, Puerto Rico, today $15^{ ext {th }}$ of April of 2008.

Francisco J. Domenech Director