Section 11.3: Controlled Substance Inventories

Section 11.3: Controlled Substance Inventories

In the state of Texas, controlled substance inventories are highly regulated and serve as a critical tool for identifying diversion, losses, and stock discrepancies. The Texas State Board of Pharmacy (TSBP) imposes inventory requirements that go far beyond federal DEA mandates, representing a frequent source of complex questions on the Texas MPJE.

Texas Annual Inventory vs. Federal Biennial Inventory

The most significant distinction between federal and Texas controlled substance inventory law is the frequency of the inventory.

• Federal DEA Rule: Requires an inventory of all controlled substances at least once every two years (biennially).
• Texas TSBP Rule: Requires an inventory of all controlled substances annually. Every Texas pharmacy must conduct a complete controlled substance inventory every year.

Inventory Date and Timing Rules

• The Annual Date: The annual inventory must be taken on the anniversary date of the initial inventory or within 4 days of that date.
• Timing: The inventory must be taken either at the opening of business or at the close of business on the inventory date.
• Documentation: The inventory record must explicitly state whether it was taken at the opening or close of business, along with the specific time and date.
• Business Hours Prohibition: An inventory cannot be taken during active business hours. If a pharmacy is open 24 hours, the inventory must be taken at a designated shift change or quiet period, and the exact time must be recorded.

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Counting Rules for Controlled Substances

When taking an inventory, the rules for whether a pharmacist must perform an exact physical count or can estimate the quantity depend on the schedule of the drug and the container size.

Example Scenarios

• An opened bottle of Hydrocodone/APAP 10/325 (Schedule II) containing approximately 50 tablets: Must be exactly counted.
• An opened manufacturer bottle of Alprazolam 0.5mg (Schedule IV) with an original size of 500 tablets: May be estimated.
• An opened manufacturer bottle of Gabapentin 300mg (Schedule V, controlled in Texas since 2019) with an original size of 1,200 capsules: Must be exactly counted because the original container size is greater than 1,000.

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Notarization of the PIC Signature

A unique and heavily tested aspect of Texas pharmacy jurisprudence is the notarization requirement for controlled substance inventories.

• Signing Duty: The Pharmacist-in-Charge (PIC) is responsible for conducting the inventory, and they must sign and date the inventory document.
• Notarization Timeline: The signature of the PIC and the date of the inventory must be notarized within 72 hours (3 business days) of completing the inventory.
• Compliance Trap: If the inventory is signed by the PIC but not notarized, or if it is notarized 4 days after completion, the pharmacy is in violation of TSBP rules.

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Other Mandatory Inventory Occasions

In addition to the annual inventory, Texas law requires a complete controlled substance inventory on several specific occasions:

1. Initial Inventory: Taken on the first day the pharmacy opens for business. If there are no controlled substances on hand, the pharmacy must record a "zero" inventory.
2. Change of PIC Inventory: When a pharmacy changes its Pharmacist-in-Charge, a complete inventory of all controlled substances must be taken on the day of the change. This inventory must be signed by the incoming PIC and notarized within 72 hours. (If the outgoing PIC is available, they should also sign, but the incoming PIC's signature is mandatory).
3. Change of Ownership: Taken on the day the ownership is legally transferred.
4. Pharmacy Closure: A closing inventory must be taken on the final day the pharmacy is open for business.
5. Newly Scheduled Drugs: If a drug is newly scheduled by the DEA or the Texas Department of State Health Services (DSHS), the pharmacy must inventory that drug on the effective date of scheduling.

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Perpetual Inventory Requirements in Texas

While many pharmacies choose to maintain a perpetual inventory for all controlled substances as a best practice, Texas law only mandates it in specific practice settings.

Class C (Institutional/Hospital) Pharmacies

• Mandatory Schedule II Perpetual Inventory: All Class C pharmacies must maintain a perpetual inventory of Schedule II controlled substances.
• Reconciliation: The perpetual inventory must be reconciled with the physical stock regularly, and any discrepancies must be investigated.

Class A (Community) Pharmacies

• General Rule: Standard Class A pharmacies are not required by state law to maintain a perpetual inventory of Schedule II drugs.
• Exceptions: A perpetual inventory is required for Class A pharmacies if:
  • The pharmacy operates a remote dispensing site (telepharmacy).
  • The pharmacy is required to do so under a specific disciplinary Board Order from TSBP.

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Texas MPJE Exam Warnings & Legal Traps

[!WARNING] The 1,000-Count Bottle Trap: On the exam, pay close attention to the size of the bottle for Schedule III-V drugs. If a question states that a pharmacist estimated the contents of an opened bottle of Tramadol (Schedule IV) that originally held 1,000 tablets, this is legal. However, if the bottle originally held 1,001 or more tablets, an estimation is a violation; an exact count must be performed.

[!IMPORTANT] The PIC Change Handover: When a new PIC takes over, they cannot rely on the previous PIC's annual inventory. A new, complete, physical inventory of all controlled substances must be conducted on the day of the change and notarized within 72 hours.