CFR 312.59
The sponsor shall assure the return of all unused supplies of the
investigational drug from each individual investigator whose participation in the
investigation is discontinued or terminated. The sponsor may authorize
alternative disposition of unused supplies of the investigational drug provided this
alternative disposition does not expose humans to risks from the drug. The
sponsor shall maintain written records of any disposition of the drug in
accordance with 312.57.
CFR 312.61
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.
CFR 312.62a
Disposition of drug. 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 disposition of the unused supplies of the drug
under 312.59.
CFR 312.62c
Record retention. An investigator shall retain records required to be
maintained under this part for a period of 2 years following the date a marketing
application is approved for the drug for the indication for which it is being
investigated; or, if no application is to be filed or if the application is not approved
for such indication, until 2 years after the investigation is discontinued and FDA is
notified.
CFR 312.69
If the investigational drug is subject to the Controlled Substances Act, the
investigator shall take adequate precautions, including storage of the
investigational drug 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.
GCP 4.6.3
The investigator/institution and/or a pharmacist or other appropriate
individual, who is designated by the investigator/institution, should maintain
records of the product's delivery to the trial site, the inventory at the site, the use
by each subject, and the return to the sponsor or alternative disposition of
unused product(s). These records should include dates, quantities,
batch/serial numbers, expiration dates (if applicable), and the unique code
numbers assigned to the investigational product(s) and trial subjects.
Investigators should maintain records that document adequately that the subjects
were provided the doses specified by the protocol and reconcile all
investigational product(s) received from the sponsor.
GCP 4.6.4
The investigational product(s) should be stored as specified by the
sponsor (see 5.13.2 and 5.14.3) and in accordance with applicable regulatory
requirement(s).
GCP 4.6.5
The investigator should ensure that the investigational product(s) are used
only in accordance with the approved protocol.
GCP 5.13.2
The sponsor should determine, for the investigational product(s),
acceptable storage temperatures, storage conditions (e.g., protection from light),
storage times, reconstitution fluids and procedures, and devices for product
infusion, if any. The sponsor should inform all involved parties (e.g., monitors,
investigators, pharmacists, storage managers) of these determinations.
GCP 5.13.3
The investigational product(s) should be packaged to prevent
contamination and unacceptable deterioration during transport and storage.
GCP 5.14.3
The sponsor should ensure that written procedures include instructions
that the investigator/institution should follow for the handling and storage of
investigational product(s) for the trial and documentation thereof. The procedures
should address adequate and safe receipt, handling, storage, dispensing,
retrieval of unused product from subjects, and return of unused investigational
product(s) to the sponsor (or alternative disposition if authorized by the sponsor
and in compliance with the applicable regulatory requirement(s)).
GCP 5.14.5
The sponsor should:
(a) Take steps to ensure that the investigational product(s) are stable over
the period of use.
(b) Maintain sufficient quantities of the investigational product(s) used in
the trials to reconfirm specifications, should this become necessary, and
maintain records of batch sample analyses and characteristics. To the
extent stability permits, samples should be retained either until the
analyses of the trial data are complete or as required by the applicable
regulatory
requirement(s), whichever represents the longer retention period.
JCAHO Medication Management Standard 7.40
Investigational medications are safely controlled and administered.
JCAHO requires organizations to protect the safety of patients participating in
clinical studies. The organization should be sensitive to the use of particular
patient populations (e.g., children, patients with cognitive impairment) in such
studies and should review all investigational medications for safety. Procedures
for the use of investigational medications must be implemented and maintained,
including a written process for reviewing, approving, supervising, and monitoring
investigational medication use. When an investigational medication protocol is
conducted independent of the organization, the organization must review and
accommodate, as appropriate, the patient's continued participation in the
protocol. When pharmacy services are provided, the pharmacy (not the
researcher) must control the storage, dispensing, labeling, and distribution
of all investigational medications in the organization.
FDA 211.142
Written procedures describing the warehousing of drug products shall be
established and followed. They shall include:
(a) Quarantine of drug products before release by the quality control unit.
(b) Storage of drug products under appropriate conditions of temperature,
humidity, and light so that the identity, strength, quality, and purity of the
drug products are not affected.