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Manufacturers of Pharmaceuticals & Controlled Substances

For manufacturers, controlled substance security is crucial. With security controls in place, employees and patients are both safe, in every stage of pharmaceutical operations.

Manufacturers have the unique challenge of managing substances in-process. All in-process substances, materials and related items 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.

Manufacturing and compounding alike should take place in an area with limited access and robust employee surveillance. That designated employee must be able to provide continuous oversight of the area. Furthermore, access to the space with controlled substances can be limited physically with walls or partitions, traffic control lines or restricted space signage.

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

Physical storage of raw, bulk and finished materials differs based on the substance type. For proper storage of substances, manufacturers should choose an Underwriters Laboratories (UL) listed secure, 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. Each schedule of substance requires differing operations; manufacturers are encouraged to consult their Field Division Office with questions.

A system 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, 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. Manufacturers play a key role in ensuring the proper handling of substances. 


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