5.1 Drug Procurement, DSCSA Track & Trace, & Storage

5.1 Drug Procurement, DSCSA Track & Trace, & Storage

Drug Procurement in California

In California, the procurement of dangerous drugs and dangerous devices is highly regulated to ensure the integrity of the supply chain and protect public health. Under California Business and Professions Code (B&P) § 4169, pharmacies, wholesalers, and other licensees may only purchase, trade, sell, or transfer dangerous drugs and devices with entities that are licensed by the California State Board of Pharmacy. This means that if a pharmacy in California orders medications from an out-of-state wholesaler, that wholesaler must hold a valid nonresident wholesaler license issued by the California Board.

Furthermore, dangerous drugs must be kept in a secure, board-licensed location. It is unlawful for a pharmacist to store pharmacy inventory at their home or any unlicensed facility. Whenever a delivery of dangerous drugs is received, it must be signed for and received by a licensed pharmacist. In a hospital setting, a designated receiving area may accept deliveries, but the drugs must be delivered to the pharmacy within one working day, and a pharmacist must immediately inventory them.

The entire drug supply chain involves numerous steps and stakeholders. From the manufacturer producing the active pharmaceutical ingredient (API) to the final dispensing by the pharmacist, every transaction must be rigorously tracked. Pharmacies are required to establish robust standard operating procedures (SOPs) to ensure that only authorized personnel are involved in the procurement process. These SOPs must outline the steps for verifying the licensure of new suppliers, managing the receipt of goods, resolving discrepancies in orders, and maintaining all associated records.

Moreover, the procurement process must also account for specialized drug products. For instance, cold chain products require meticulous attention from the moment they are ordered. The receiving personnel must verify that the cold chain was maintained during transit, often using temperature data loggers included in the shipment. Any deviation must be immediately reported, and the affected products quarantined until their viability can be determined. Similarly, the procurement of controlled substances requires strict adherence to DEA regulations, utilizing the Controlled Substance Ordering System (CSOS) or physical DEA Form 222s, which add another layer of complexity to the supply chain management.

Drug Supply Chain Security Act (DSCSA)

The Drug Supply Chain Security Act (DSCSA), enacted by Congress as part of the Drug Quality and Security Act (DQSA) of 2013, establishes a national system for tracing prescription drugs through the supply chain. The primary goal of the DSCSA is to prevent counterfeit, falsified, stolen, contaminated, or otherwise harmful drugs from entering the U.S. market.

The "3Ts": Transaction Information, History, and Statement

Under the DSCSA, trading partners (manufacturers, wholesalers, repackagers, and dispensers/pharmacies) must provide and receive product tracing information when a drug changes ownership. This tracing information consists of three components, often referred to as the "3Ts":

1. Transaction Information (TI): Includes the proprietary or established name of the product, strength, dosage form, National Drug Code (NDC), container size, number of containers, lot number, expiration date, transaction date, and the names and addresses of the businesses transferring and receiving the product.
2. Transaction History (TH): A paper or electronic statement that includes the transaction information for each prior transaction going back to the manufacturer of the product.
3. Transaction Statement (TS): A statement, in paper or electronic form, that the entity transferring ownership is authorized as required by the DSCSA, received the product from an authorized person, did not knowingly ship a suspect or illegitimate product, had systems and processes to comply with verification requirements, did not knowingly provide false transaction information, and did not knowingly alter the transaction history.

Record Retention: Pharmacies must retain the DSCSA tracing information (TI, TH, and TS) for six (6) years from the date of the transaction. This aligns with many FDA record-keeping requirements, though it differs from the standard 3-year retention rule for general pharmacy prescription records in California.

Suspect and Illegitimate Products

Pharmacies must have processes in place to identify suspect products. A "suspect product" is one that the pharmacy has reason to believe is potentially counterfeit, diverted, stolen, intentionally adulterated, or otherwise unfit for distribution. If a pharmacy identifies a suspect product, it must quarantine the product and conduct an investigation. If the investigation confirms the product is "illegitimate," the pharmacy must notify the FDA (using Form FDA 3911) and all trading partners within 24 hours.

Storage Conditions (USP <659>)

Proper storage is critical to maintaining the stability and efficacy of medications. The United States Pharmacopeia (USP) General Chapter <659> Packaging and Storage Requirements defines specific temperature ranges that pharmacies must strictly adhere to. In California, the Board of Pharmacy rigorously inspects temperature logs and storage conditions.

Note: Controlled room temperature allows for temporary excursions between 15°C and 30°C (59°F to 86°F) that are experienced in pharmacies, hospitals, and warehouses.

Temperature Monitoring and Excursions

Pharmacies are required to monitor and document the temperatures of their refrigerators, freezers, and room temperature storage areas daily, either manually or using an automated continuous temperature monitoring system. The logs must be reviewed and maintained.

If a temperature excursion occurs (i.e., temperatures deviate outside the acceptable ranges), the pharmacy must have a written protocol to address it. The protocol typically involves quarantining the affected drugs, contacting the manufacturer to determine if the drugs are still safe and effective, and documenting the event and the outcome. If the manufacturer cannot guarantee the stability of the product after the excursion, the drugs must be discarded.

Reverse Distributors and Expired Drugs

Pharmacies periodically accumulate expired, damaged, or recalled medications. These drugs must be promptly removed from the active dispensing inventory to prevent accidental dispensing. In California, pharmacies typically use a licensed reverse distributor to process and dispose of these items.

For non-controlled dangerous drugs, the reverse distributor receives the drugs, processes them for return to the manufacturer for credit, and handles the destruction of non-returnable items according to EPA and state environmental regulations.

For controlled substances, the process is more stringent. A pharmacy may transfer expired Schedule II-V controlled substances to a reverse distributor who is registered with the DEA.

• When transferring Schedule II drugs to a reverse distributor, the reverse distributor must issue a DEA Form 222 to the pharmacy.
• For Schedule III-V drugs, the transfer must be documented with an invoice.

The reverse distributor is then responsible for completing the DEA Form 41 (Registrants Inventory of Drugs Surrendered) when the controlled substances are destroyed. The pharmacy transferring the drugs does not fill out DEA Form 41; the entity actually destroying the drugs (the reverse distributor) does.

Maintaining a rigorous and compliant supply chain is fundamental to modern pharmacy practice. By strictly adhering to procurement laws, product tracing requirements, and environmental storage standards, pharmacies protect patients from the significant hazards posed by adulterated, counterfeit, or subpotent medications. The use of electronic systems for logging, tracing, and verifying product legitimacy has become an indispensable part of pharmacy operations in the 21st century.