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Pharmacy Guide: Meeting Controlled Substance Regulatory Requirements

Due to the country’s opioid crisis, it has become commonplace to read reports which show government enforcement actions asserted against pharmacies and their owners for both substantive and administrative violations of the Controlled Substances Act (CSA). Similarly, manufacturers and wholesale drug distributors can also implement restrictions on pharmacies, by way of Pharmacy Restriction Letters, that can impact a pharmacy’s ability to purchase controlled substances which can be detrimental to a pharmacy’s ability to provide routine care. Therefore, it is important for pharmacy owners and managers to think about the types of questions that a government inspector, auditor, or investigator might be trying to answer about a respective pharmacy meeting its controlled substance regulatory requirements. While not meant to be all inclusive, some of these questions are listed below.

To learn more about Frier Levitt’s ability to review your pharmacy’s adherence to controlled substances’ regulatory requirements, contact Frier Levitt to speak with an attorney.

Are pharmacy personnel aware of their Corresponding Responsibility requirements?

A prescription for a controlled substance must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice. The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is not a valid prescription and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances.

Are pharmacy personnel aware of the requirements to maintain an inventory on a biennial basis in accordance with its regulatory responsibilities?

A biennial inventory may be taken on any date which is within two years of the previous biennial inventory date.

Is the biennial inventory annotated with Beginning of Business (BOB) or Close of Business (COB)?

CSA regulations require the inventory date be indicated on the inventory. Inventory may be taken either as of opening of business or as of the close of business.

Are pharmacy personnel aware of the requirements to maintain a Power of Attorney for those individuals authorized to order controlled substances on behalf of the registrant?

If a registrant authorizes one or more individuals, to issue orders for Schedule I and II controlled substances on the registrant’s behalf, the registrant must execute a power of attorney for each such individual. The power of attorney must be available for inspection together with other order records.

Are pharmacy personnel aware of their requirements to maintain distribution records?

Inventory and other records are required to be kept and be available, for at least 2 years from the date of such inventory or records, for inspection and copying by authorized employees of the Drug Enforcement Administration.

Are pharmacy personnel aware of the requirement to report any theft or significant loss of any controlled substances?

A pharmacy must notify the Field Division Office of the Administration in his area, in writing, of any theft or significant loss of any controlled substances within one business day of discovery of the theft or loss and also complete, and submit to the Field Division Office in his area, DEA Form 106 regarding the theft or loss.

Are pharmacy personnel aware of the requirements regarding the disposal of controlled substances?

Controlled substance inventory may be disposed of in one of the following ways:

  • Promptly deliver that controlled substance to a reverse distributor’s registered location by common or contract carrier or by reverse distributor pick-up at the registrant’s registered location
  • Delivery by common or contract carrier or pick-up at the registrant’s registered location to: The registered person from whom it was obtained, the registered manufacturer of the substance, or another registrant authorized by the manufacturer to accept returns or recalls on the manufacturer’s behalf

Are pharmacy personnel aware of the responsibilities as provided for by the Combat Methamphetamine Epidemic Act (CMEA)?

Regulations require specific requirements for retail sales of scheduled listed chemical products to individuals for personal use.

Are pharmacy personnel aware of the requirement for annual CMEA self-certification and were they completed?

Any person who makes a sale at retail of a scheduled listed chemical product must submit to the DEA the self-certification. The certification is not effective unless the certification includes a statement that person understands each of the requirements that apply and agrees to comply with those requirements.

Are pharmacy personnel aware of the requirement that biennial inventory and other records be separated into Schedule II controlled substances (C2) and Schedules III, IV, and V (C3-C5)?

Inventories and records of all controlled substances listed in Schedule I and II must be maintained separately from all other records of the pharmacy. Additionally, inventories and records of Schedules III, IV, and V controlled substances shall be maintained either separately from all other records of the pharmacy or in a form that the information required is readily retrievable.

Are pharmacy personnel aware that Controlled Substance Ordering System (CSOS) receipts must be annotated with quantity and date received?

Upon receipt of a controlled substances shipment, the pharmacy must create a record of the quantity of each item received and the date received and the record must be electronically linked to the original order and archived.

Are pharmacy personnel aware that a CSOS Subscriber Agreement must be on file?

All CSOS certificate holders must maintain a copy of the subscriber agreement that the Certification Authority provides for the life of the certificate.

Are pharmacy personnel aware that DEA form 222s must be readily retrievable?

DEA Forms 222 must be maintained separately from all other records and are required to be kept available for inspection for a period of two years as well as all copies of unaccepted or defective forms with each statement attached.

Are pharmacy personnel aware that DEA 222s must have the ship quantity and date filled in?

Pharmacies must record on Copy 3 of the DEA Form 222 the number of commercial or bulk containers furnished on each item and the dates on which the containers are received.

Are pharmacy personnel aware that controlled substances invoices must be readily retrievable?

Inventory and other records required to be kept under the CSA must be kept be available, for at least 2 years from the date of such inventory or records, for inspection and copying by the DEA.

Are pharmacy personnel aware that C2 invoices must be filed separately from C3-C5 invoices?

Inventories and records of all controlled substances listed in Schedule I and II must be maintained separately from all other records of the pharmacy. Likewise, inventories and records of Schedules III, IV, and V controlled substances shall be maintained either separately from all other records of the pharmacy or in a form readily retrievable from ordinary business records of the pharmacy.

Are pharmacy personnel aware that controlled substance invoices have ship quantity and date filled in?

In recording dates of receipt other transfers, or destruction, the date on which the controlled substances are actually received otherwise transferred, or destroyed shall be used as the date.

Are pharmacy personnel aware that controlled substances prescriptions must be readily retrievable and separately filed?

A pharmacy’s paper prescriptions for Schedule II controlled substances must be maintained in a separate prescription file. However, paper prescriptions for Schedules III, IV, and V controlled substances may be maintained either in a separate prescription file or in such form that they are readily retrievable from the other prescription records of the pharmacy.