DEA-Approved Vault Space Guidelines | Ensure the Proper Storage of Controlled Substances with UPM Pharmaceuticals
How to Ensure Proper Storage of Controlled Substances
The DEA has explicit guidelines that must be followed, but the security requirements that apply depend on what type of storage is being used. The rules for the storage of controlled substances in pharmacy settings and that of a drug vault in a production facility can be completely different.
The first step in complying with DEA controlled substance secure storage guidelines is determining what type of pharmaceuticals you'll be storing — Schedule I-V. From there, the federal requirements specify what type of controlled substance safe and other safety measures must be in place.
DEA-Approved Vault Space Requirements for Storage of Controlled Substances
There are many security requirements for the storage of controlled substances in pharmacy locations that are determined by the class of drugs.
Schedule I-V Drug Storage Requirements
There are two primary controlled substance safe storage options that apply to all classes of narcotics:
- Safe or Steel Cabinet - If a steel cabinet or controlled substance safe is used and weighs less than 750 pounds, it must be bolted down to prevent it from being easily removed. It also must be able to withstand ten minutes of attempted forced entry.
- Vault - Regulations regarding vaults include specified thicknesses, reinforcements, alarms, contact switches and detection devices. The door and frame unit must be able to withstand ten minutes of forced entry and 20 hours of both lock picking and using X-ray technology.
In addition, a self-closing and self-locking gate is required if frequent access to the vault is necessary during working hours, such as in a pharmacy narcotic safe.
Additional DEA Controlled Substance Secure Storage Guidelines for Schedule III, IV or V Narcotics
The building used for DEA-approved safe storage must include perimeter security that limits access during working hours. Other necessities include:
- An electronic burglar alarm system that transmits a signal directly to the police or a central station protection agency upon unauthorized entry.
- Secure doors; if the door doesn't close and lock automatically, it must be closed and locked at all times when not in use (or be observed at all times by a responsible employee when in use), and doors with hinges mounted on the outside must have the hinges welded to prevent removal.
- Locks, either with a multiple-position combination device or a keyed lock type with limited access.
Combinations must only be shared with a minimal number of employees and have the ability to be changed when said employees are terminated.
UPM DEA Vault Storage Capabilities
We offer the following options for the storage of controlled substances that we manufacture and package:
- On-Site Warehousing - 7,200 square feet of DEA-approved vault space
- Off-Site Warehousing - 8,300 square feet of DEA-approved vault space
How to Avoid DEA Vault Storage Penalties
Compliance and the documentation of compliance must be your top priorities in order to avoid disciplinary action. The consequences of not acting in accordance with the mandates can be severe, including loss of DEA registration and criminal prosecution. Audits make it imperative to prioritize proper record keeping.
DEA-Approved Vault Space Recordkeeping
The lack of proper records to substantiate compliance is the same as non-compliance in the eyes of the DEA. Every organization that is registered with the DEA must maintain precise recordkeeping practices for the storage and disposal of narcotics. Unannounced inspections can derail your operations if your records aren't in order.
Benefits of Choosing UPM as Your DEA-Approved Vault Storage Partner
UPM has award-winning expertise in the production of DEA-controlled substances while following secure storage guidelines. As a respected narcotics manufacturing CDMO, we safely develop your product while negotiating the DEA regulatory complexities on your behalf.
We provide the following benefits:
- Experience - more than 20 years of experience in controlled substance manufacturing — and in the storage of controlled substances in the pharmacy manufacturing arena.
- Manufacturing Capabilities - the ability to accommodate the unique needs of controlled substance manufacturing.
- DEA-Approved Vault Space - 15,800 square feet of drug vault storage for controlled substances.
For controlled substance safety and compliance, you can rely on the expertise of UPM. To learn more about how we can help manage an effective DEA compliance program and ensure that your facility satisfies the DEA controlled substance secure storage guidelines, send us a message or call (423) 989-8000 to speak to a partner.CONTACT US
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