11.4 Drug Acquisition & Distribution, Office-Use Sales, and Delivering Prescriptions to Patients

11.4 Drug Acquisition & Distribution, Office-Use Sales, and Delivering Prescriptions to Patients

Blueprint items 4.1 (ordering, acquisition, and distribution) and 4.3 (delivery of drugs) are covered here. Schedule II ordering (Form 222 and CSOS) is in Section 11.1, and the DEA 5% distribution rule is in Section 8.2.

Where a pharmacy may buy drugs

• Licensed sources only. Under R156-17b-615, a manufacturer or wholesaler may furnish prescription drugs only to a person licensed by DOPL (or another state) to possess, dispense, or administer them. It must deliver only to the licensee's business address on the license, or to an authorized agent whose identity and authority are established.
• Controlled substances may be distributed only by a licensee, and only on an order form under DOPL rules or a lawful federal order (§ 58-37-105(6)). Manufacturers and wholesalers may provide them only on an order from an appropriately licensed person, with records of the purchaser, drug, quantity, and dates (§ 58-17b-617(2)(b)).
• Samples and patient assistance. Non-controlled drugs may be distributed as samples to persons licensed to sell, prescribe, administer, or research legend drugs, or supplied through a manufacturer's patient assistance program to qualifying patients (§ 58-17b-617(2)(a)). Buying or selling samples remains unlawful (§ 58-17b-501(4)), and federal PDMA rules limit sample distribution to practitioners and to health care entity pharmacies at a practitioner's request.
• Supply-chain documentation. Under the federal DSCSA, the pharmacy deals only with authorized trading partners and keeps transaction information and statements for six years. Utah's wholesale rule adds pedigree requirements for drugs that have left the normal distribution channel, kept five years (R156-17b-615(10)).
• Stock labeling. Manufacturers and wholesalers may sell only stock containers labeled with the manufacturer's (and any packer's or distributor's) name and place of business, with tablets and capsules marked with an identification code, and each package bearing an expiration date and lot number (§ 58-17b-616).

Sales outside the normal course of business (§ 58-17b-615)

Prescription drugs sold in bankruptcy, at public auction, at freight liquidation, or in any other sale outside the normal course of business are subject to special rules:

• The seller must be licensed as a prescription drug distributor or wholesaler, with a regular license or a temporary license for that sale, and must retain a Utah-licensed pharmacist to verify proper transport, storage, and condition. The seller gives DOPL written notice before the sale.
• A pharmacy may acquire such drugs only if they come with a certificate signed by the seller's pharmacist that they were not adversely affected, and a qualified pharmacist employed by the buyer determines they pose no greater threat than drugs bought through normal channels.
• The verifying pharmacist (and any pharmacy or wholesaler employing or connected to that pharmacist) may not buy from that seller.

Sales to practitioners for office use (§ 58-17b-624; R156-17b-624)

A licensed pharmacy may repackage or compound a prescription drug for sale to a practitioner if:

• the drug is not a compounded drug, or it is compounded but not a controlled substance;
• the pharmacy labels it "for office use only";
• the practitioner administers it in the office or facility; and
• the practitioner does not dispense it to the patient (except a DMP under Part 8).

R156-17b-624 requires compliance with all state and federal law, including the FDCA. Under federal law, compounding without patient-specific prescriptions can take a pharmacy outside the section 503A exemptions (Section 12.1).

Pharmacy-to-pharmacy and intracompany distribution

• A chain pharmacy warehouse performs intracompany sales or transfers to chain pharmacies under common ownership (R156-17b-102(8)). It is licensed in the appropriate class.
• Transfers of controlled substances between separately registered locations, even under the same owner, require DEA records (Form 222 or CSOS for Schedule II, invoices for Schedules III–V) and fall under the 5% rule unless the pharmacy is registered as a distributor (21 CFR 1307.11).

Delivering dispensed prescriptions to patients

The statute (§ 58-17b-602(9))

A pharmacy may deliver a prescription drug to a patient or the patient's agent only:

• in person at the pharmacy; or
• by the U.S. Postal Service, a licensed common carrier, or supportive personnel, if the pharmacy takes reasonable precautions to make sure the drug is delivered to the patient or agent, or returned to the pharmacy.

The rule (R156-17b-608(1))

A pharmacy that delivers by USPS, common carrier, or supportive personnel must:

1. use shipping containers and processes that keep the drug stable, potent, and at appropriate temperatures throughout delivery, using packaging the manufacturer or USP <1079> recommends;
2. seal containers so opening or tampering is evident;
3. have policies and procedures for accountability, safe delivery, temperature compliance, late arrivals, and replacing compromised drugs;
4. provide an electronic, telephone, or written way to offer counseling; and
5. tell the patient what to do if the package or drug was compromised in shipment.

Supportive personnel may deliver a pre-filled prescription without a pharmacist in the immediate area (R156-17b-607). Counseling for delivered prescriptions is covered in Section 5.1. Undeliverable returns may be redistributed only if they come back within 14 days and meet the other conditions in R156-17b-608(2) (Section 7.3). A Class D pharmacy delivering into Utah must provide a toll-free counseling number and notify patients of substitutions.

Controlled substances

Registrants may ship dispensed controlled substances to patients by mail or common carrier in compliance with federal and carrier rules. Filling or advertising the filling of prescriptions for Utah residents without a Utah license or a license in the dispensing state is unlawful and a third degree felony (§§ 58-17b-501(7), -504(1)).

Scenario

A liquidation company offers a pharmacy pallets of prescription drugs from a bankrupt distributor at deep discounts. The pharmacy may buy only if the seller is licensed (at least temporarily), a seller-retained Utah pharmacist certifies that the drugs were not adversely affected, and the pharmacy's own pharmacist determines they pose no added risk. Otherwise, it must decline.