The Biennial Inventory

893.07 Records

(1) Every person who engages in the manufacture, compounding, mixing, cultivating, growing, or by any other process producing or preparing, or in the dispensing, importation, or, as a wholesaler, distribution, of controlled substances shall:

• On January 1, 1974, or as soon thereafter as any person first engages in such activity, and every second year thereafter, make a complete and accurate record of all stocks of controlled substances on hand. The inventory may be prepared on the regular physical inventory date which is nearest to, and does not vary by more than 6 months from, the biennial date that would otherwise apply. As additional substances are designated for control under this chapter, they shall be inventoried as provided for in this subsection.
• On and after January 1, 1974, maintain, on a current basis, a complete and accurate record of each substance manufactured, received, sold, delivered, or otherwise disposed of by him or her, except that this subsection shall not require the maintenance of a perpetual inventory.

Compliance with the provisions of federal law pertaining to the keeping of records of controlled substances shall be deemed a compliance with the requirements of this subsection.

(2) The record of controlled substances received shall in every case show:

• The date of receipt.
• The name and address of the person from whom received.
• The kind and quantity of controlled substances received.

(3) The record of all controlled substances sold, administered, dispensed, or otherwise disposed of shall show:

• The date of selling, administering, or dispensing.
• The correct name and address of the person to whom or for whose use, or the owner and species of animal for which, sold, administered, or dispensed.
• The kind and quantity of controlled substances sold, administered, or dispensed.

(4) Every inventory or record required by this chapter, including prescription records, shall be maintained:

• Separately from all other records of the registrant
• Alternatively, in the case of Schedule III, IV, or V controlled substances, in such form that information required by this chapter is readily retrievable from the ordinary business records of the registrant.

From the Pharmacists Manual on Controlled substances-

All required records concerning controlled substances must be maintained for at least two years for inspection and copying by duly authorized DEA officials. 21 U.S.C. 827(b) and 21 CFR 1304.04(a). Records and inventories of schedule II controlled substances must be maintained separately from all other records of the registrant. 21 CFR 1304.04(h)(1). All records and inventories of schedules III, IV, and V controlled substances must be maintained either separately from all other records or in such a form that the information required is readily retrievable from the ordinary business.

From the Code of Federal Regulations

General requirements. Each inventory shall contain a complete and accurate record of all controlled substances on hand on the date the inventory is taken, and shall be maintained in written, typewritten, or printed form at the registered location. An inventory taken by use of an oral recording device must be promptly transcribed. Controlled substances shall be deemed to be “on hand” if they are in the possession of or under the control of the registrant, including substances returned by a customer, ordered by a customer but not yet invoiced, stored in a warehouse on behalf of the registrant, and substances in the possession of employees of the registrant and intended for distribution as complimentary samples.

A separate inventory shall be made for each registered location and each independent activity registered, except as provided in paragraph (e) (4) of this section. In the event controlled substances in the possession or under the control of the registrant are stored at a location for which he/she is not registered, the substances shall be 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. The inventory may be taken either as of opening of business or as of the close of business on the inventory date and it shall be indicated on the inventory.

From 465-.015

It is unlawful for any pharmacist to knowingly fail to report to the sheriff or other chief law enforcement agency of the county where the pharmacy is located within 24 hours after learning of any instance in which a person obtained or attempted to obtain a controlled substance, as defined in s. 893.02, or at the close of business on the next business day, whichever is later, that the pharmacist knew or believed was obtained or attempted to be obtained through fraudulent methods or representations from the pharmacy at which the pharmacist practiced pharmacy. Any pharmacist who knowingly fails to make such a report within 24 hours after learning of the fraud or attempted fraud or at the close of business on the next business day, whichever is later, commits a misdemeanor of the first degree, punishable as provided in s. 775.082 or s. 775.083.

DEA Report of Significant Loss

A sufficient report of the fraudulent obtaining of controlled substances under this subsection must contain, at a minimum, a copy of the prescription used or presented and a narrative, including all information available to the pharmacist concerning the transaction, such as the name and telephone number of the prescribing physician; the name, description, and any personal identification information pertaining to the person who presented the prescription; and all other material information, such as photographic or video surveillance of the transaction.

Sheriff / Local Police Requirements

From 465.015

It is unlawful for any pharmacist to knowingly fail to report to the sheriff or other chief law enforcement agency of the county where the pharmacy is located within 24 hours after learning of any instance in which a person obtained or attempted to obtain a controlled substance, as defined in s. 893.02, or at the close of business on the next business day, whichever is later, that the pharmacist knew or believed was obtained or attempted to be obtained through fraudulent methods or representations from the pharmacy at which the pharmacist practiced pharmacy. Any pharmacist who knowingly fails to make such a report within 24 hours after learning of the fraud or attempted fraud or at the close of business on the next business day, whichever is later, commits a misdemeanor of the first degree, punishable as provided in s. 775.082 or s. 775.083. A sufficient report of the fraudulent obtaining of controlled substances under this subsection must contain, at a minimum, a copy of the prescription used or presented and a narrative, including all information available to the pharmacist concerning the transaction, such as the name and telephone number of the prescribing physician; the name, description, and any personal identification information pertaining to the person who presented the prescription; and all other material information, such as photographic or video surveillance of the transaction.

Pitfalls of Inaccurate DEA Documentation or Late CSOS

Inaccurate documentation, late receipt of controlled substances, and failures in saving electronic Controlled Substance Ordering System (CSOS) records are significant compliance violations that can lead to severe penalties.

Key pitfalls regarding DEA paper and CSOS receipt include:

1. Inaccurate Documentation (Paper and Electronic)

• Missing Information: Records that are incomplete, lack key information, or contain mathematical errors can result in suspension of licenses and DEA-imposed penalties.
• Discrepancies: Inability to produce required records, such as biennial inventory, or having logs that do not match physical inventory or patient records, constitutes an automatic fail in a DEA inspection
• Inaccurate CSOS Data: If a CSOS certificate or order is inaccurate, it must be addressed, and all electronic Schedule II orders must be maintained in an electronic format for two years.

2. Late or Failed CSOS Electronic Receipt/Record Saving

• Failure to Save/Record: Records must be "readily retrievable". Failure to save CSOS records (including unaccepted or defective orders) or not maintaining them for the required two-year period can lead to fines up to $18,759 per violation.
• Electronic Receipt Issues: Failure to record the exact date and quantity of Schedule II, III-V substances received can cause a failed audit, especially if the records are not immediately available.
• System Vulnerabilities: Criminals may hack CSOS systems or authentication credentials, and failing to maintain secure CSOS credentials can be a major source of non-compliance.
  
  

3. Consequences of Mismanagement

• Financial Penalties: DEA fines can escalate quickly, with potential penalties of over $18,000 for each individual missing line-item or documentation error.
• Legal Action: Violation of these regulations can lead to a letter of admonition, suspension/revocation of registration, or criminal charges.
• Operational Disruption: A failed DEA inspection can lead to an Immediate Suspension Order (ISO), which halts all controlled substance activity.

For optimal compliance, pharmacists must ensure that all records are accurately maintained, easily read, and retrievable, and to avoid sharing CSOS certificates.

Mid-Level Practitioners

Qualified Advanced Practice Registered Nurses (APRNs/NPs) in Florida with an autonomous practice license can prescribe controlled substances (CS), provided they have met specific educational requirements, hold a master's or doctoral degree in a clinical specialty, and follow the Florida Board of Nursing formulary. Autonomous NPs are limited to a 7-day supply for Schedule II controlled substances, unless it is a psychiatric medication prescribed by a psychiatric nurse.

Key Details on Controlled Substance (CS) Prescribing for Autonomous APRNs in Florida:

• Authority: Under HB 607 (2020), qualified APRNs can practice independently, including prescribing, without a physician supervision protocol.
• Requirements: To prescribe controlled substances, the APRN must have a master's or doctoral degree in a clinical nursing specialty, and comply with continuing education requirements.
• Registration: Autonomous NPs must register with the state and meet specific experience requirements (3,000+ hours in the last 5 years).

Limitations:

• Schedule II: Limited to a 7-day supply, except for psychiatric mental health controlled substances, as noted in the Florida Statute 464.012.
• Formulary: APRNs must adhere to a formulary established by a committee that lists controlled substances they cannot prescribe or that have restricted uses, as outlined in Florida HB 423.
• Scope: Autonomous practice is generally restricted to primary care (family medicine, general pediatrics, general internal medicine).

Physician Assistants (PAs): While PAs have increased autonomy, their authority to prescribe controlled substances is generally still tied to a supervision agreement or, as noted in CS/HB 607, restricted to specialized rules.

In Florida, a Board rule (agency rule) must have specific legislative reference. Under Florida’s Administrative Procedure Act Chapter 120.54, an agency must have both a specific statutory grant of rulemaking authority and a specific law to be implemented, meaning rules cannot be adopted without legal authority.

Key requirements include:

• Rulemaking Authority: The rule must be authorized by a statute, not just generally related to a purpose.
• Specific Reference: The notice of proposed rule development must include the specific legal authority (statutory citation) for the rule,
• Implementation: The rule must directly implement or interpret a specific statutory power or duty.
• School Boards: School board rules must be based on statutory authority.

While Chapter 120.54 generally mandates this for state agencies, specific statutory references are essential for validation, particularly if a rule is challenged as an invalid exercise of delegated authority.