Investigational Drugs Requiring Double Lock System
(07/31/2009)

Question 1:

I need to know if it is required by the FDA that investigational drugs be under a double lock system. Our pharmacy is under a security system that only allows entry to employees after their badge has been verified by the security box. A Clinical Research Assistant that visited our pharmacy seems to think that a lock needs to be placed on the investigational drug room door inside the pharmacy also. The investigational drug room does not have a lock on it because access is needed by our pharmacists 24 hours a day to initiate or to make doses for studies that have patients enrolled in them. Please let me know the FDA requirements for this situation.

Answer 1:

In reference to your question concerning investigational drugs, only controlled substances are required by FDA regulation to be stored in a "...securely locked, substantially constructed cabinet or other securely locked, substantially constructed enclosure, access to which is limited, to prevent theft or diversion of the substance into illegal channels of distribution." [See 21 CFR 312.69].

While the regulations do not require locked cabinets for investigational drugs that are NOT controlled substances, the investigator is nevertheless still required to maintain control of the investigational drug:

"An investigator shall administer the drug only to subjects under the investigator's personal supervision or under the supervision of a subinvestigator responsible to the investigator. The investigator shall not supply the investigational drug to any person not authorized under this part to receive it." [See 21 CFR 312.61.]

"An investigator is required to maintain adequate records of the disposition of the drug, including dates, quantity, and use by subjects. If the investigation is terminated, suspended, discontinued, or completed, the investigator shall return the unused supplies of the drug to the sponsor, or otherwise provide for the disposition of the unused supplies of the drug under §312.59." [See 21 CFR 312.62(a).]

Certainly, limiting access to the investigational drug products is in keeping with good clinical practice. Because the regulations are fairly general, however, study sites and sponsors have the flexibility to develop their own procedures for handling, storing, and dispensing the investigational drugs.


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