21 CFR Section 1304 Flashcards
How long must inventory and other records be kept?
Two years from the date or such inventory or records
May financial and shipping records, such as invoices and packing slips, be kept at a central location?
Yes, if the registrant has notified the Administration of their intent to keep central records. Unless the registrant is informed that permission is denied, the registrant may main central records starting 14 days after receipt of the sent notification.
Which records cannot be kept at a central location?
Not executed order forms and inventories.
How quickly must a registrant be able to deliver records to the registered location, if kept at a central location?
Within two business days upon receipt of a written request from the Administration.
Do registrants need to notify the Special Agent in Charge to obtain approval to maintain records on an in-house computer system?
No
Where must be inventories be kept?
At the registered location.
What substances are deemed “on” hand, and thus included in the inventory?
In possession or under control of the registrant. Includes substances returned, ordered but not yet invoiced, stored in a warehouse on behalf of the registrant, and in possession of employees of the registrant and intended for distribution as complimentary samples.
What activities require separate inventories?
Separate registered locations and independent registered activities.
When in the day must inventory be taken?
The opening or close of business, which should be indicated on the inventory.
If controlled substances are stored in a location where the registrant is not registered, how is inventory handled?
Substances are included in the inventory of the registered location to which they are subject to control or to which the person possessing the substance is responsible.
When must initial inventory occur?
On the date the person first engages in the manufacture, distribution, or dispensing of controlled substances.
When must inventory take place?
At least every two years. Biennial inventory may be taken on any date which is within two years of the previous biennial inventory date.
If a previously non-controlled drug is made controlled, when must inventory be taken on the newly controlled drug stock?
On the effective date of a rule by the Administrator.
What information must be included in the inventory for each controlled substance in finished form?
Name of the substance, each finished form (Tablet or liquid concentration), number of units or volume of each finished form in each commercial container (100-tab bottle or 3-mL vial), and number of commercial containers of each finished form (four 100-tablet bottles)
What information must be included in the inventory for damaged, defective, or impure substances awaiting disposal?
Name, total quantity of the substance to the nearest metric unit weight or total number of units of finished form, and reason for the substance being maintained and whether it is capable of use in the manufacture of any controlled substance in finished form.
For dispensers and researchers making inventory, how are the number of units of each finished form of a controlled substance in a commercial container that has been opened determined?
Schedule I or II - Make an exact count or measure.
Schedule III,IV, or V - Estimated count or measure, unless the container holds more than 1000 tablets or capsules, in which case an exact count must be made.
