Packagers of Controlled Substances & Pharmaceuticals
From start to finish, handling controlled substances requires constant security, especially in the packaging stage. With security controls in place, employees and patients are both safe.
Like other non-practitioners, packagers 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, boxes, tanks, vessels, bins and containers should be locked in an adequately secured area.
For ultimate security, packaging should take place in a limited-access area equipped with comprehensive surveillance. Employees responsible for surveillance must provide continuous oversight of the substance packaging area. Furthermore, access to the space can be limited physically with walls, partitions or restricted space signage.
And during packaging, only those employees necessary for operation should be allowed in controlled substance areas. Should a non-authorized person pass through the area, like a business guest or maintenance, an authorized employee must make adequate, written observation of the area.
Physical storage of small quantities of raw, bulk and finished materials – whether packaged or unpackaged -- differs based on the substance type. For proper storage of substances in all stages of packaging, packagers 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; compounders are encouraged to consult their Field Division Office with questions.
While not required, additional packaging precautions are recommended. Securely wrapping and sealing packages containing controlled substances is encouraged. Plus, using unmarked or coded boxes or shipping containers helps protect against in-transit losses. Whether you are producing laser labels, prescription blanks, bags or other equipment related to DEA regulated controlled substance security, always remember that strict oversight is paramount.
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
For all parties in pharmaceutical operations, safety is the ultimate goal. Packagers and Controlled Substance Labelers play an important part in ensuring that substances are properly handled and security requirements are being met. As always, consult your local DEA Agent to ensure you are in compliance with regulations.
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