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Labelers & Labeling Security for Prescription Drugs

Controlled substance security is critical in every stage, and labeling is no exception. With security controls in place, employees and patients are both safe.

Labelers, like other non-practitioners, handle substances in-process. All in-process substances should be returned to the correct storage area at the termination of the workday if incomplete. And the processing area, tanks, vessels, bins and containers should be locked in an adequately secured area.

Labeling, for ultimate security, should take place in a limited-access area with comprehensive employee surveillance. Employees responsible for surveillance must be able to provide continuous oversight of the substance handling area. Furthermore, access to the space can be limited physically with walls or partitions, traffic control lines or restricted space signage.

And during production, only those employees necessary for operation should be allowed in labeling areas. Should a non-authorized person pass through the area, like maintenance staff or a business guest, adequate written observation of the area must be made by an authorized employee.

Physical storage of small quantities of raw, bulk and finished materials differs based on the substance type. For proper storage of substances – before, during and after labeling -- labelers should select an Underwriters Lab (UL) listed burglary-resistant safe, steel cabinet or vault that can withstand:

  • 30 man minutes against surreptitious entry
  • 10 man minutes against forced entry
  • 20 man hours against lock manipulation
  • 20 man hours against radiological attack

Furthermore, for those weighing less than 750 pounds, safes or security containers should be bolted, strapped or secured to the floor or the wall. Depending on the quantity and type of substance being stored, an alarm system connected to police or other security agency is critical too.

Vaults must be equipped with an alarm system and, if operations require frequent access, a self-closing and self-locking day-gate. And no matter what security is in place, labelers should limit access to the controlled substance storage area to the minimum number of authorized employees.

Should a labeler store controlled substances in a public warehouse, select a facility, storage warehouse or terminal that meets the security requirements. It’s the responsibility of the registrant, not the warehouse, to keep substances secure.

The DEA evaluates security systems on both an element-by-element and overall basis. Each schedule requires differing operations; labelers are encouraged to consult their Field Division Office with questions. No matter you area of expertise in creating labels for controlled substances – be they Laser Labels, Thermal, Pinfed or standard prescription for the commercial pharmacy it is your responsibility to ensure compliance with security requirements where applicable. Controlled substances, no matter if they are Schedule I, II, III, IV or V each have specific DEA regulations that require compliance and proper planning.

A plan for reporting theft or loss of substances should be in place if the worst occurs. Within one business day of discovery of a theft or loss, the labeler should send written notification to the Field Division Office, including:

  • the quantity lost
  • the specific substance lost
  • whether the incident corresponds with a specific person
  • a pattern of losses (if any)
  • if the specific controlled substances are candidates for diversion
  • local trends or indicators

Safety is the ultimate goal for all parties in pharmaceutical operations. Labelers are significant in ensuring that substances are properly handled.  


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