§ 27.17. Security for Schedule II controlled substances.

 (a)  From the time that a Schedule II controlled substance is received for storage in the prescription area until the time that controlled substance has been prepared and compounded into an individual prescription, no person except a licensed pharmacist or a licensed pharmacist intern or, in an institution, a licensed physician or registered nurse, may have access to the controlled substances or work in an area where open containers of the controlled substances are shelved or stored. The Board will consider the following measures as adequately controlling access to the controlled substances:

   (1)  A safe, vault or other storage facility in compliance with storage requirements for BNDD Schedule II drugs.

   (2)  A chest or cabinet of sound construction secured to a wall or floor and able to be securely locked.

   (3)  A wire cage with a door able to be securely locked.

 (b)  The Board may approve alternative security measures proposed by an applicant upon a showing that a degree of security would be provided equal to or greater than that set forth in subsection (a).

 (c)  The occasional entry of other persons into an area where the controlled substances are accessible in order to clean, deliver or perform other necessary functions shall be allowed only when a licensed person is present and supervising.

 (d)  The pharmacist manager shall be responsible for assuring that licensed persons, employes and others who enter the prescription area know and abide by the standards of security and that the other measures are taken as may be necessary to insure their enforcement.

Cross References

   This section cited in 6 Pa. Code §  22.62 (relating to conditions of provider participation); 28 Pa. Code §  113.15 (relating to locked storage); and 28 Pa. Code §  561.15 (relating to locked storage).



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