Sate of New York Controlled Substances Regulations & Rules for Storage
Our Products and State Controlled Substances Rules:
How We Can Help You
Dealing with controlled substances is no joke. Whether you’re running a pharmacy, hospital dispensary, warehouse, manufacturing plant or doctor’s office, if you produce, store or sell controlled substances then you need to not only protect those substances; you need to do it according to state regulations. That means more than putting chemicals/drugs/component parts in a strong, steel box. You have to control the access, design the room, create operational procedures and use the proper storage equipment. Proper security isn’t a one-step system; it’s more like a puzzle. If you don’t have all the pieces locking together in the right place, you’re not going to see the complete picture.
In this article, we’re going to give the example of controlled substances rules and regulations from New York State and some examples of our TL rated and Class 5 safes and how they can help you cover all your bases.
A guide like the Rules and Regulations on Controlled Substances in New York State can be a treasure trove of information. There are similar guides for all U.S. states. These tomes will give the ins and outs of what your state expects of you and your business. The guide is divided into sections about manufacturers, distributors, importers and exporters, research and chemical analysis, institutional dispensers, proscribing and dispensing controlled substances, how to dispense to addicts, habitual users and treatment programs, keeping reports and records and dealing with materials like syringes and toxic vapors. We’ll give you a description of each section but we’ll be focusing on the security concerns.
The first section of the document, (which can be found here in its entirety), is called General Provisions. First off, it gives you a list of definitions for terms like the GSA and automated dispensing system, (which means a system approved by the department that performs operations or activities, other than compounding or administration, relative to storage, packaging, counting, labeling and dispensing controlled substances, and which collects controls and maintains all transaction information.) This section also gives a list of exemptions to the Public Health Law; a count of who is exempt from possession restrictions concerning controlled substances. People like government employees in the domain of their specific duties, common carrier and warehousemen in the course of their jobs and people who have been granted temporary leave to handled controlled substances.
The following part is about exceptions, reclassifications and exemptions of scheduled controlled substances. It gives several listings about substances that New York State has decided have either no potential for abuse, contains certain chemicals or is habit forming and which list they should be or have been moved to. The next section defines license classifications. There are many different classes of licenses; ones for out-of-state manufacturers, researchers, dispensers; licenses for treatment programs and instructional activities as well as hospital pharmacies and laboratories and importers/exporters. The section also explains which licenses (and in some cases, multiple licenses) are needed for different setups and situations.
The final section of General Provisions is about security and safeguarding controlled substances. Being on top of these regulations is about fulfilling the legal requirements, like making sure your controlled substances are being kept in the same place the DEA has on file and allowing them to be available for inspection at a government official’s convenience. This section also discusses access to substances, how the administrative head of each organizations is responsible for the proper safeguarding of said substances, operators in general are responsible for substances on or in the organization’s buildings/property. Basically, this section is here to make sure you’re aware that it is on you. You are responsible for the controlled substances in your possession.
Next up is Manufacturers, Distributors, Importers and Exporters; the first point is that you must register with the appropriate federal agencies concerning your licenses and the substances you handle. Then you must address the additional requirements for manufacturers and distributors; which include, having a good moral character, a required level of education, a clean legal record and the proper level of experience. There are also additional requirements for importers and exporters; which are mainly about license types.
The next part is about minimal security standards for non-practitioner handling of Schedule I and II controlled substances. A large concern is having a proper storage area and for that; you need a GSA approved Class 5 safe. That is a requirement that we can definitely help you out with. More on those safes toward the end of the article; but it’s not just safes and vaults. You have to have a proper room with day gates and tamper-proof alarms. Your vault must also have at least one of the following; sensitive ultrasonic equipment within the vault, complete electrical lacing in the floors/walls/ceiling or other devices designed to detect illegal entry. We can help you with electronic security as well.
The security requirement for Schedule III/IV/V substances complies with a lot from the previous sections with a few differences. They must be kept under constant surveillance; there must also be alarms on the outer perimeter of whatever building they’re stored in as well as additional security features like fences and guards. Codes for holding substances in multiple areas is also covered, primarily concerned with licenses and accessibility. Security standards for agents are also handled as well as standards for public warehouses, contract carriers and manufacturing areas. Good faith injury and response to theft/loss is also addressed with the dual issue of suspicious orders.
You must keep records of everything! Distributors, sales orders, shipping manifests, records of drugs manufactured/sold, the whole kit and caboodle. The best practice is to keep both paper and electronic records in safe, secure and separate locations. We can help you protect both your paper records and electronic records storage.
All controlled substances in your possession must be listed and identifiable. They must be labeled using an in-house filling system and a national drug code identification number. This will help you keep track of everything that comes and goes; protecting you and your customers. Check with your local law enforcement and government with laws and codes concerning having free drug samples on hand and whither you can hand them out to customers or receive them from suppliers.
Next we get into Research, Instructional Activities and Chemical Analysis. The first rule about these types of activities is clear and simple; no does any of them with an appropriate license and permission. If a person receives the right licenses and is approved by local and federal authorities; then they can start up their programs. Researchers must keep exact records of what they do and what materials they use.
Being an Institutional Dispenser is very important and cannot be done without a license. The rules and the requirements for being an institutional dispenser change depending on what substances you’re handling and what type of business/organization you’re a part of. To get these licenses, you’re going to have to go through local, state and federal government (DEA) agencies. Then you have to be concerned about detailed records; if you’re going to be dispensing controlled substances then you better be able to account for every milligram.
The next part is an important one; minimum security standards. It circles back to having the proper storage equipment; GSA approved Class 5 safes and the accompanying accessories. You need to have equipment like the Class 5 drawers and safes; which include IPS Containers for storing computer equipment and online records and we even hit the nail on the head with our Narcotics Safes which are rated for use by the U.S. Military. Safeandvault can also address your other security requirements by supplying you with items like the SCIF CDX-09 locks. The Class 5 safes come with 2-5 drawer design options, single X-O9 or S&G 2740 locks and they’re an excellent choice for clients who need to replace their older Hamilton or Mosler Safe products.
Another impressive group of products are our TL Rated Burglary Safes. A design like the NQA-1 PRO-Tector is a great choice because of its two hour fire rating, custom safe interiors, the ability to integrate with existing security systems and custom lock configurations. The TL 30x6 Safe is another great option because of its massive 4-way bolt work, the ability withstand 30 minutes of torch attacks and glass re-lockers. The TRTL 30 Safes meet the DEA requirements for the storage of narcotics. It does this with its 5” door, 3 ½” composite body and mechanical re-lockers. It is UL rated to withstand 30 minutes of attack from tools and torches. We also offer the multi-variable TL 30 and TL 15 Rated Safes; we can customize these items to fit your needs.
The rest of the Rules and Regulation document covers more about reports and records, dealing toxic vapors and disposable medical products and how to deal with offenses and enforcement. We suggest you go through the entire document and research how the codes may be different in your own area.
www.safeandvault.com can assist you in virtually any security situation; because we use the best products and safes available. We don’t just sale you a heavy metal box; we provide you with the right safe or secure cabinet for your products, company and clients. Let us provide those missing pieces.