Process Maps: Investigational Drug Pharmacy
According to 21 CFR 312.62(2), an investigator is required to maintain adequate accountability records for the investigational drug or biologic. At UCDHS all investigational drugs or biologics (also known as “test articles”) are handled by the Investigational Drug Services (IDS), a Division of the Pharmacy Department. IDS stores and dispenses drugs in accordance with Good Clinical Practice Guidelines, the study protocol requirements, and all applicable rules and regulations.
More information see IDS website or Contact IDS:
2315 Stockton Blvd, Rm DT 0762, Sacramento, CA 95817
Phone: (916) 703-4093
FAX: (916) 703-7048
For a thorough training on Investigational Drug Accountability at UCD Medical Center please see presentation:
IDS stores and dispenses drugs in accordance with Good Clinical Practice Guidelines, the study protocol requirements, and all applicable rules and regulations. IDS is responsible for:
The IDS maintains an inventory of each investigational drug stored in the pharmacy. This record (Drug Accountability Form or DARF) contains:
- Drug’s name, dosage form, strength, lot number and expiration date.
- Dispensing Information:
- Subject info (ID, initials, etc)
- Quantity dispensed/received/wasted
The IDS also maintains randomization codes of patients receiving the drug. As a rule, treatment should not be unblinded except under emergency conditions, which are typically described in the protocol. Before unblinding, the process should be discussed with the study sponsor.
At the conclusion of the study, the pharmacist returns, transfers or disposes of all unused investigational drugs according to the specific instructions provided by the sponsor or sponsor-investigator.
Prior to the pharmacy dispensing properly prepared study medication(s), they must verify that:
- The subject has signed the informed consent document
- The study protocol is available in the pharmacy
- The protocol is currently approved by the IRB
- Drug information is available in the pharmacy
- There is a valid and complete physician’s order for the investigational agent.
- The prescription label for an investigational drug will be marked “For Investigational Use Only”.
Only the PI and sub-investigators listed on the FDA Form 1572 may write orders for study agents, except for:
- “Authorized Prescribers List”
- Clinicians on “IRB Research Personnel List”
The prescription must contain ALL information currently required by state, federal and institutional laws and policies, including: name & address of patient; name & quantity of drug; date of issue; typed or printed name, address and phone# of prescriber; signature of prescriber.
UCDHS Policy and Procedure 1508 “Investigational Drug Distribution” (section III) defines the "administration" of the drug as "the direct application of the drug to the body of the patient or research subject by injection, inhalation, ingestion, or other means." Specifically, section IV, part H, states that "only physicians, nurses, and authorized licensed personnel will dispense and/or administer investigational drugs and biologics." In addition, teaching patients to administer (self-administer) a drug or biologic must be done by licensed personnel. Unlicensed personnel (CRCs) may pick up the investigational drug from the IDS in tamper-proof packaging and deliver it to the patient.
IDS follows written sponsor instruction for disposal/destruction documented in the Investigational Agent Disposition Record.
IDS may administer dietary supplements if the research involves the use of a supplement to treat a disease (intended for use in diagnoses, cure, relief, treatment, or prevention of disease or intended to affect the structure or function of the body), or involves significant risk to subjects. If any of the above criteria are met, the FDA requires submission of an IND (Investigational New Drug) Application. For studies under INDs, the supplement is treated as investigational drug. See IND Website for details.