7.3 Returned Drugs, Consumer Disposal & the Charitable Prescription Drug Recycling Program
Key Takeaways
Accepting back and redistributing an unused drug after it has left the pharmacy is unprofessional conduct unless an exception in Utah Code § 58-17b-503 applies (Utah Code § 58-17b-502(1)(e)).
A Utah pharmacist may redistribute a drug returned from a nursing care facility, jail, prison, or state hospital if it was stored under licensed supervision, is in a unit pack or sealed container, and returns to the original dispensing pharmacy.
A drug from a failed delivery may be redistributed if returned by the same carrier within 14 days of shipping and the pharmacist confirms its integrity, and a controlled substance's CSD report must be corrected (R156-17b-608(2)).
Utah's Charitable Prescription Drug Recycling Program excludes controlled substances except buprenorphine for medication-assisted treatment, compounded drugs, and REMS patient-registry drugs.
An eligible Utah recycling pharmacy may charge $0–$10 when accepting and $0–$5 when dispensing a donated drug (R156-17b-901(3)).
7.3 Returned Drugs, Consumer Disposal & the Charitable Prescription Drug Recycling Program
Blueprint item 2.4 covers "returning or reusing drugs." Utah's rules are §§ 58-17b-502(1)(e), 58-17b-503, 58-17b-623, Part 9 of the Pharmacy Practice Act (§§ 58-17b-901 to -907), R156-17b-608 and -901, and the federal disposal rules in 21 CFR Part 1317.
The general rule
"Except as provided in Section 58-17b-503, accepting back and redistributing any unused drug, or a part of the unused drug, after the unused drug has left the premises of a pharmacy" is unprofessional conduct (§ 58-17b-502(1)(e)). DOPL's fine schedule sets $1,000–$5,000 for a first offense and $10,000 for a subsequent one.
What is prohibited is redistribution, meaning putting the drug back into stock and dispensing it to someone else. A pharmacy may still take a patient's unwanted drug for disposal (§ 58-17b-623; see below). The drug cannot return to inventory unless an exception applies.
The three exceptions (§ 58-17b-503(2))
| Exception | Conditions |
|---|---|
| (a) Charitable recycling | Donated and redispensed under Part 9 (below) |
| (b) Institutional unit-pack returns | Prescribed to a patient in a nursing care facility, licensed ICF for people with an intellectual disability, state prison, county jail, or state hospital; stored under a licensed health care provider's supervision per manufacturer recommendations; in a unit pack (tamper-resistant, nonreusable, single-dose, single-drug package showing lot number and expiration) or the manufacturer's sealed container; returned to the original dispensing pharmacy; originally dispensed by a licensed pharmacist or intern; and the return complies with FDA and DEA rules |
| (c) Failed delivery | The pharmacy tried to deliver by USPS, licensed common carrier, or supportive personnel; the same person or carrier returned it; and a pharmacist determines under FDA rules and DOPL rule that it was not adversely affected |
For failed deliveries, R156-17b-608(2) requires the pharmacist to verify the drug came back within 14 days of the ship date, use clinical judgment that the drug and its packaging are intact and uncompromised, and, for a controlled substance, correct the CSD report.
Note
Drugs dispensed in ordinary amber vials to community patients, or returned by a patient who has taken them home, fit none of these exceptions. They may be accepted only for disposal.
Consumer drug disposal
- Utah: a pharmacy may accept unused prescription drugs for disposal as federal law allows (§ 58-17b-623). Licensees disposing of controlled substances must follow 21 CFR Part 1317 and keep disposal records five years (R156-37-606).
- DEA authorized collectors (21 CFR Part 1317): a retail or hospital pharmacy may modify its DEA registration to become a collector. Key requirements:
- The collection receptacle is securely fastened to a permanent structure, locked, and has a small opening that allows contents to be added but not removed.
- It is placed where employees can see it, in the immediate proximity of where controlled substances are stored.
- Only ultimate users put their own drugs in the receptacle. Staff may not count, sort, inventory, or otherwise handle the contents.
- Inner liners are waterproof, tamper-evident, tear-resistant, and opaque, with a unique ID number. They are installed and removed by two employees and sealed immediately.
- Sealed liners are destroyed on site or transferred for destruction (for example, by a reverse distributor) so that the contents are non-retrievable.
- Controlled and non-controlled drugs may be mixed in the receptacle.
Utah's Charitable Prescription Drug Recycling Program (Part 9; R156-17b-901)
The program lets eligible donors and individuals transfer eligible drugs to eligible pharmacies for dispensing to medically indigent individuals.
| Element | Rule |
|---|---|
| Eligible donors | Nursing care facilities, assisted living facilities, licensed ICFs, manufacturers, wholesale distributors, eligible pharmacies, and physicians' offices. Individuals may donate to an eligible pharmacy, or to a physician's office that is an eligible donor. |
| Eligible pharmacies | Registered with DOPL as eligible, and either a licensed Class A or B pharmacy or operated by a county, county health department (or its contractor), DHHS, or a charitable clinic |
| Eligible drugs (§ 58-17b-904) | In a unit pack or manufacturer's sealed container, or an injectable; unopened (or a cancer drug in an unopened single-unit dose removed from a multidose package); accepted and dispensed before the beyond-use or manufacturer expiration date; not adulterated or mislabeled |
| Excluded | Controlled substances, except buprenorphine for opioid use disorder (medication-assisted treatment); compounded drugs; drugs dispensable only to patients registered with the manufacturer under FDA requirements (R156-17b-901(5)) |
| Recipients | A medically indigent individual in Utah with a practitioner's prescription: uninsured without reasonable means to buy the drug, or insured but unable to afford their share |
| Fees | Handling fees of $0–$10 before accepting and $0–$5 before dispensing (R156-17b-901(3)) |
| Pharmacy duties | Inspect every drug for eligibility; follow DSCSA; label to show the drug was dispensed under the program; keep written procedures; create a special training program for pharmacists and technicians and keep training records two years |
| Liability | Absent bad faith or gross negligence, participants are not civilly or criminally liable solely for manufacturing, donating, accepting, or dispensing eligible drugs (§ 58-17b-906) |
Utah's statute sets no fixed minimum remaining shelf life. The drug just has to be accepted and dispensed before its expiration or beyond-use date. Refrigerated injectables such as sealed insulin pens are not excluded by category.
A patient returns to the drive-through five minutes after pickup with an unopened bottle of atorvastatin, saying her doctor switched her medication. Under Utah law, what may the pharmacy do with the drug?
Return it to active stock if the seal is intact
Accept it for disposal, but not return it to stock or redispense it, because none of the § 58-17b-503 exceptions applies
Transfer it to another pharmacy for resale
Redispense it to a Medicaid patient to avoid waste
A pharmacy's courier cannot deliver a package and brings it back to the pharmacy eight days after it was shipped. What must the pharmacist do before redistributing the drug under R156-17b-608(2)?
Confirm it came back within 14 days of shipping, determine its integrity and packaging are intact, and correct the CSD report if it is a controlled substance
Redistribute it without inspection, because the courier is pharmacy staff
Hold it for 30 days before returning it to stock
Destroy it, because any drug that leaves the pharmacy may never be redistributed
An eligible pharmacy in Utah's Charitable Prescription Drug Recycling Program receives several donated items. Which one may it accept?
An unopened bottle of zolpidem (Schedule IV)
A manufacturer-sealed carton of insulin glargine pens expiring in 10 months
A compounded omeprazole suspension prepared two weeks ago
An opened patient vial of lisinopril tablets
What handling fees may an eligible Utah pharmacy charge in the Charitable Prescription Drug Recycling Program?
No fees of any kind
The drug's average wholesale price
A flat $25 per prescription
$0–$10 before accepting a drug and $0–$5 before dispensing it
Sections you finish are checked off in the contents.