4/1/14 - What are the FDA issues around security?

A – The FDA does not have the same type of security regulations as the DOT. However, there are several security related issues.

Drug Storage
The 2003, Draft Guidance for Industry - Current Good Manufacturing Practice for Medical Gases summarizes the FDA thinking and regulations about medical gas security:

B.    Security

Medical gas manufacturers are wholesale distributors who are subject to the requirements of § 205.50 - Minimum requirements for the storage and handling of prescription drugs and for the establishment and maintenance of prescription drug distribution records.

All facilities used for medical gas distribution must be secure from unauthorized entry (§ 205.50(b)(1)).

Entry into areas where medical gases are held must be limited to authorized personnel (§ 205.50(b)(1)(iii)).  We recommend areas where nitrous oxide is held be especially secure.

The security requirements of § 205.50(b) apply to all facilities used for medical gas distribution.  FDA interprets this regulation to include all facilities where loaded medical gas delivery trucks are parked prior to making deliveries, including at an employee's home when a loaded medical gas delivery truck is driven there and parked overnight for early morning runs.

A manufacturer could use an alarm system to secure the building and keep loading docks secure, rather than open and easily accessible.

Keep in mind that the Draft Guidance does not carry the same authority as the underlying regulations. However, it does represent the last published agency thinking about security and medical gases.

Nitrous Oxide
The FDA does not define “especially secure” storage areas for nitrous oxide. The Compressed Gas Association has published excellent guidelines for storing and securing nitrous oxide. GAWDA members can sign up for free access to these CGA resources. For further details, see:
•    CGA G-8.3, Safe Practices for Storage and Handling of Nitrous Oxide
•    CGA P-50, Site Security Standard
•    CGA P-51, Transportation Security Standard for the Compressed Gas Industry
•    CGA P-52, Security Standard for Qualifying Customers Purchasing Compressed Gases

Though not all items will apply in all cases, consider the following:
•    Inventory control systems to detect theft or loss
•    Access controls
•    Property fencing
•    Secondary fencing for nitrous cylinders and bulk storage
•    Lockout devices to secure valves on bulk storage
•    Security systems, alarms, etc.
•    Procedure to determine if a customer is legitimate