Controlled Substances Recordkeeping

Q. How long do controlled substance inventory records need to be kept?

A. Controlled substance inventory records including invoices must be kept for five years. KRS 218A.200


Q. How often must a controlled substance inventory be completed?    

A. The initial inventory shall be taken on the date the pharmacy first engages in dispensing.  After the initial inventory is taken, an inventory must be taken at least every two years, on any date which is within two years of the previous controlled substance inventory. Inventory for newly federally controlled substances must be inventoried on the effective date of the scheduling or rescheduling.  For Kentucky, when a non-controlled drug is moved to a schedule by Kentucky, it must be inventoried within 30 days of the effective date of the scheduling.  Title 21 CFR 1304.11 and KRS 218A.200(7)   


Q. Does a controlled substance inventory have to be completed when there is a change in pharmacist-in-charge?

A. No, but it is strongly encouraged.


Q. What information is required on the controlled substances inventory?

A. When the inventory was taken, as of opening of business or as of close of business and the date (if an audit is done, need a starting day).  CII drugs must be counted.  CIII-V drugs can be estimated if in stock bottles less than 1000.  The DEA strongly encourages the pharmacy to include the name, address and DEA registration of the pharmacy on the controlled substances inventory, along with the signature of the person(s) responsible for the inventory, however, this is not required.  Title 21 CFR 1304.11 and Pharmacist Manual Section VII


Q. Can a physician purchase stock bottles of controlled substances from a pharmacy for office use? 

A. Yes, a pharmacy may wholesale the controlled substances to the physician as long as the total number of dosage units wholesaled is not greater than 5% of the total number of dosage units of controlled substances dispensed in the previous 12 month period.  The request cannot be written as a prescription with the physician’s office as the patient because a prescription is for a legitimate patient with a legitimate medical need.  Information required:  if the drug is a CII, a DEA 222 form must be used; for CIII-V drugs the pharmacist must make an invoice and record the following information: name, address and DEA registration of the physician; name, address and DEA registration of the supplying pharmacy; drug name, strength, quantity and NDC number/manufacturer, lot number and expiration date; date of the transaction.  This invoice shall be stored with other controlled substances invoices. 902 KAR 55:060 and KRS 218A.200


Q. Can an ambulance service purchase stock bottles of controlled substances from a pharmacy?

A. Yes, an ambulance service has a medical director who is a physician who is responsible for the drugs on an ambulance.  A pharmacy may wholesale the controlled substances to the ambulance service in care of the medical director as long as the total number of dosage units is not greater than 5% of the total number of dosage units of controlled substances dispensed in the previous 12 month period.  The request cannot be written as a prescription with the physician’s office as the patient because a prescription is for a legitimate patient with a legitimate medical need.  Information required:  if the drug is a CII, a DEA 222 form must be used; for CIII-V drugs the pharmacist must make an invoice and record the following information: name, address and DEA registration of the ambulance service and physician; name, address and DEA registration of the supplying pharmacy; drug name, strength, quantity and NDC number/manufacturer, lot number and expiration date; date of the transaction.  This invoice shall be stored with other controlled substances invoices.902 KAR 55:060 and KRS 218A.200


Q. Can a pharmacy purchase stock bottles of controlled substances from another pharmacy?

A. Yes, a pharmacy may wholesale the controlled substances to another pharmacy as long as the total number of dosage units is not greater than 5% of the total number of dosage units of controlled substances dispensed in the previous 12 month period.  Information required:  if the drug is a CII, a DEA 222 form must be used; for CIII-V drugs the pharmacist must make an invoice and record the following information: name, address and DEA registration of the receiving pharmacy; name, address and DEA registration of the supplying pharmacy; drug name, strength, quantity and NDC number/manufacturer, lot number and expiration date; date of the transaction.  This invoice shall be stored with other controlled substances invoices. 902 KAR 55:060 and KRS 218A.200