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Distributors & Distribution of Controlled Substances

Controlled substance security is critical in every stage, especially in distribution. With security controls in place, employees and patients are both safe.

Like other non-practitioners, distributors handle substances in-process. Distributors include manufacturers, repackers, private-label and own-label distributors, jobbers, brokers, warehouses, independent wholesale drug traders and retail pharmacies.

Distributors should return all in-process substances 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.

All facilities used for substance distribution should be secure from unauthorized entry. Only employees necessary for operation should be permitted, and access to the premises should be well controlled, with a well-lit exterior. 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.

Distribution facilities should be the right size for operations, have appropriate storage areas, be well-maintained and free of infestation by insects or rodents. Furthermore, distributors should have a quarantine area for storage of prescription drugs that are outdated, damaged, misbranded or unfit for sale.

As with all stages of pharmaceutical operations, security is critical at distribution facilities – with an alarm or secrutiy system, well-lit exterior and entry points for authorized personnel.

Physical storage of small quantities of raw, bulk and finished materials differs based on the substance type. For proper storage of substances, distributors 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.

The DEA evaluates security systems on both an element-by-element and overall basis. Each schedule requires differing operations; distributors are encouraged to consult their Field Division Office with questions.

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 distributor 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. Distributors are significant in ensuring that substances are properly handled. 

Always remember to check your state regulations as well and consult with your DEA agent. Handling, distributing or storing of legend or prescription pharmaceuticals , controlled substances, medical gases , transfilling of medical gases, or supplies and devices that contain  or are accompanied by legend/prescription drugs to persons other than a consumer or patient may categorize you as a distributor or Wholesale distributor, such as any person or entity engaged in wholesale distribution of prescription drugs.


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NarcoticsSafes.com, A Division of K.L. Security Enterprises, Inc.

928 Robinson Street

West Lafayette, IN 47906. USA

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