Outsourcing Facilities and Security
An outsourcing facility combines pharmaceutical drugs to tailor meet the needs of an individual; a person may be allergic to a component of a medication or may need a solid drug transformed to liquid form for consumption. This compounding of drugs must be done by a pharmacist, physician, or under supervision of a pharmacist. The individual drugs are FDA approved, but the new combination of two drugs is not. There are two categories of facilities: 503A and 503B.
Facilities that fall under the 503A category are pharmacies licensed for operation under Federal and State Codes. Facilities that fall under the 503B category are pharmacies, or often manufacturers, that have applied for 503B licensing through the FDA. The 503B status gives a facility the license to compound drugs on a larger scale, save money by producing compounded drugs in bulk, and the ability to relay these savings on to a consumer.
Applying for status as a 503B facility is voluntary, but affords benefits. The facility may be able to qualify certain compounded drugs for FDA approval exemptions, but must still conform to current good manufacturing practice requirements and FDA regulations.
Regulations for security requirements of outsourcing facilities can be found within the Code of Federal Regulations. 21CFR13.01.72 outlines the specific guidelines of storage for each schedule of drug. Listed are a few key notes of interest taken directly from legislature:
Schedules I and II
- May suffice with safe or steel cabinet:
- Safe or cabinet must have following specifications: 30 man-minutes against surreptitious entry, 10 man-minutes against forced entry, 20 man-hours against lock manipulation, and 20 man-hours against radiological techniques.
Or if quantities require a vault:
Walls, floors, and ceiling are constructed of at least 8 inches of reinforced concrete or other substantial masonry, reinforced vertically and horizontally with ½ inch steel rods tied 6inches on center, or the structural equivalent to such reinforced walls, floors, and ceilings.
Following specifications: 30 man minutes against surreptitious entry, 10 man-minutes against forced entry, 20 man-hours against lock manipulation, and 20 man-hours against radiological techniques
One of the following: Electrical lacing of the walls, floor, and ceilings; sensitive ultrasonic equipment within the vault; a sensitive sound accumulator system; or such other device designed to detect illegal entry as may be approved by administration
Schedules III, IV and V
- Subject to the same storage security regulations as schedues I and II
- May utilize a building used specifically for storage of controlled substances providing the building:
- Has an electrical alarm system
- Perimeter security during working and non-working hours
- Etc.
- May store drugs in a DEA approved cage within a building on the premises
- Cage must have walls of no less than No. 10 gauge steel fabric mounted on steel posts
- Posts are at least one inch in diameter, set in concrete or installed with lag bolts that are pinned or brazed, and placed no more than ten feet apart with 1 and 1 ½ inch reinforcements every sixty inches
Etc.
Helpful Links:
https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers
https://www.fda.gov/drugs/human-drug-compounding/regulatory-policy-information
https://www.fda.gov/drugs/human-drug-compounding/regulatory-policy-information
https://www.klsecurity.com/index.php/products/vaults-and-doors/dea-approved.html
When you’re ready to begin the process of securing your facility, the consultants at KL Security are available to assist. Well versed in government regulations and recent legal mandates, we are prepared to ensure your business will pass requirements.
TOLL FREE 1-866-867-0306
Information has been gathered from sources deemed reliable but not guaranteed and is subject to change without notice. All license information and security measures taken directly from the Code of Federal Regulations: 21CFR13.01.72
