this file a minimum of two years from the date the order was filled.
B.A distributor licensee handling controlled substances in Schedules III, IV, and V shall maintain complete and accurate records of all distributions for a minimum of two years from the date of each distribution. These records shall contain the full name, address, and registration number, if any, of the recipient, the common or established name of the controlled substance, its dosage, form, and strength, amount, and date of distribution.
C.A distributor shall not sell or distribute drugs or drug devices except to a person or facility authorized by law or regulation to procure or possess drugs or drug devices.
D.A distributor shall maintain and follow a written procedure to assure the proper handling and disposal of returned goods.
E.A distributor shall maintain a written policy for handling recalls and withdrawals of products due to:
1.any voluntary action on the part of the manufacturer;
2.the direction of the Food and Drug Administration, or any other federal, state, or local government agency; or
3.replacement of existing merchandise with an approved product with a new package design.
AUTHORITY NOTE:Promulgated in accordance with R.S. 40:972.
HISTORICAL NOTE:Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 34:2147 (October 2008).
A.Orders for Schedule I and II Controlled Substances
1.General Requirements. A licensee acquiring controlled substances in Schedules I and II shall maintain a file of the duplicate copies of all order forms used to obtain controlled substances within these schedules. Each duplicate copy of any order form used to order controlled substances shall be kept in this file a minimum of two years from the date the order form was completed. This file shall be kept separate from the licensee's other business or professional records. These records shall contain the full name, address and license number of the supplier, the common or established name of the controlled substance, its dosage form and strength, the amount, and the date of receipt.
2.DEA Form 222. Either a DEA Form 222 or its electronic equivalent is required for each distribution of a Schedule I or II controlled substance except for the following:
a.distributions to persons exempted from registration by federal or state law;
b.exports from the United States that conform to federal requirements;
c.deliveries to a registered analytical laboratory or its agent approved by DEA;
d.delivery from a central fill pharmacy to a retail pharmacy.
a.Electronic orders for Schedule I or II controlled substances shall comply with the federal requirements set forth in 21 CFR §1305.21 and §1311 or their successors.
i.To be valid, the purchaser shall sign an electronic order for a Schedule I or II controlled substance with a digital signature issued to the purchaser, or the purchaser's agent, by DEA as provided by federal law.
ii.The following data fields shall be included on an electronic order for Schedule I and II controlled substances:
(a).a unique number the purchaser assigns to track the order. The number shall be in the following 9-character format: the last two digits of the year, X, and six characters as selected by the purchaser;
(b).the purchaser's DEA registration number;
(c).the name of the supplier;
(d)the complete address of the supplier (may be completed by either the purchaser or the supplier);
(e).the supplier's DEA registration number (may be completed by either the purchaser or the supplier);
(f).the date the order is signed;
(g).the name (including strength where appropriate) of the controlled substance product or the National Drug Code (NDC) number (the NDC number may be completed by either the purchaser or the supplier);
(h).the quantity in a single package or container;
(i).the number of packages or containers of each item ordered.
iii.An electronic order may include controlled substances that are not in schedules I and II and non-controlled substances.
b.Procedure for Filling Electronic Orders
i.A purchaser shall submit the order to a specific supplier. The supplier may initially process the order (e.g., entry of the order into the computer system, billing functions, inventory identification, etc.) centrally at any location, regardless of the location's registration with DEA. Following centralized processing, the supplier may distribute the order to one or more registered locations maintained by the supplier for filling. The licensee shall maintain control of the processing of the order at all times.
ii.A supplier may fill the order for a Schedule I or II controlled substance, if possible and if the supplier desires to do so and is authorized to do so under federal law.
iii.A supplier shall do the following before filling the order.
(a).Verify the integrity of the signature and the order by using software that complies with federal law to validate the order.
(b).Verify that the digital certificate has not expired.
(c).Check the validity of the certificate holder's certificate by checking the DEA's Certificate Revocation List.
(d).Verify the licensee's eligibility to order the controlled substances by checking the certificate extension data.
iv.The supplier shall retain an electronic record of every order, and, linked to each order, a record of the number of commercial or bulk containers furnished on each item and the date on which the supplier shipped the containers to the purchaser. The linked record shall also include any data on the original order that the supplier completes. Software used to process digitally signed orders shall comply with DEA's requirements digital certificates for electronic orders.
v.If an order cannot be filled in its entirety, a supplier may fill it in part and supply the balance by additional shipments within 60 days following the date of
Louisiana Register Vol. 34, No. 10 October 20, 2008