The “Protecting Patient Access to Emergency Drugs Act, 2017” (the “Act”), which came into force on November 17, 2017, amended the Controlled Substances Act to allow for a new registration category for emergency departments handling controlled substances. Standards have also been established for the registration of emergency services and new requirements for the supply, storage and registration of controlled substances related to their handling. In addition, the law allows emergency medical workers to administer controlled substances outside of the physical home page 62635presence of a medical director or authorized health professional under a valid standing or verbal order. The Drug Enforcement Administration is proposing to amend its regulations to bring them into compliance with the law and implement its requirements. The next big thing that all 14001 registers should theoretically have is the applicability text. So, again, it should be one to four sentences and it should be about how this legal requirement or compliance obligation applies to our organization or how it applies specifically to this operation. So, if you have a multi-operational business with different activities in different locations, each location should have an applicability text for a specific compliance obligation. So even if you have two plants in upstate New York, you want to have two different versions of the applicability texts for each plant. Many companies will cheat and they only have one version of the applicability text because their factories are quite similar.

But in fact, you should have two versions of the applicability texts to make them as relevant as possible to a particular operation. Under proposed Section 1301.13, EMS agencies, if permitted by state law, can be registered as a new type of business. A new “EMS Agency” business activity will be added to the registration application and renewal application so that EMS agencies can obtain DEA registration, allowing EMS agencies to deliver controlled substances to their locations specified by Start Printed Page 62648 without obtaining a separate registration as a distributor. This registration allows EMS staff to administer controlled substances outside of the physical presence of a medical director or the approval of health professionals in the course of providing emergency services. Once an EMS agency registration has been issued, the EMS agency should use the online system to identify all the locations it wishes to designate under the EMS Agency DEA registration. Now I`m just changing the other slide here, the next slide. And interestingly, up to 30% of callers today aren`t certified or aren`t there, so maybe we`ll come back to that later. The next question, after discussing why we are introducing management standards, is why a legal register? Therefore, a legal register is a requirement of ISO 14001 as well as other standards. And we will discuss this in more detail, where exactly 14001 requires it, but a number of management standards not only 14001, but also energy standards such as 50001 and even 18001 require you to have a document that can be called a legal registry or legal profile. But at the end of the day, it is a list of laws, regulations, codes, statutes that apply to your organization within the framework of standards, so in this case provided by the environment, 50001 is a standard for energy management, which also requires knowledge of energy regulations.

But at the end of the day, all companies or organizations and all people are subject to the law. 5.1 Details of the list of applicable legal requirements and other requirements to be compiled by LTM, as well as the frequency of retrieval and the personnel responsible for maintaining the records, are set out in the Legal Registry. Third, subject to certain restrictions, the Act authorizes emergency medical services professionals from an accredited MSS organization to administer the controlled substances listed in Schedule II. III, IV or V outside the physical presence of a medical director or an enabling health professional in the course of providing ambulance services. 21 U.S.C. 823(j)(4). EMS professionals may only perform such administrations if they are authorized by state law and by standing or verbal orders that meet a number of legal requirements. Now, some additional elements that we certainly see in legal registries, but that are certainly not common to all and that apply even to ISO 14001 legal registries. But these are elements that we think are pretty good. There are positives and negatives about everyone, including in your legal registry. The first is a summary of the requirement.

For example, a summary of the requirement is usually between one and four sentences and is a summary of the regulatory requirement or, if it is something else, a voluntary requirement that you have implemented in your organization. This is a summary of the requirement that is not specific to your organization. So we are talking about describing exactly what the Air Emissions Regulations are trying to accomplish in the jurisdiction in which you operate.