10.5 Drug Product Conditions That Prohibit Dispensing: Adulterated, Misbranded, Outdated, Recalled & Suspect Products
Key Takeaways
Selling, distributing, or dispensing an outdated, misbranded, or adulterated drug or device is unprofessional conduct in Utah (Utah Code § 58-17b-502(1)(c)).
Dispensing a medication the FDA has discontinued is unprofessional conduct under R156-17b-502(19).
A Utah pharmacy must remove out-of-date legend drugs and controlled substances from inventory at regular intervals according to the labeled dates (R156-17b-605(1)).
During an inspection, DOPL may temporarily seize, or box and seal, drugs suspected of being adulterated, misbranded, or outdated (Utah Code § 58-17b-103(3)).
Under the federal DSCSA, a dispenser that finds an illegitimate product must quarantine it and notify FDA and its trading partners within 24 hours.
10.5 Drug Product Conditions That Prohibit Dispensing: Adulterated, Misbranded, Outdated, Recalled & Suspect Products
Before dispensing, a pharmacist must confirm that the product itself may lawfully be dispensed, not just that the prescription is valid.
Adulteration and misbranding (federal FDCA)
| Adulterated (21 U.S.C. § 351), examples | Misbranded (21 U.S.C. § 352), examples |
|---|---|
| Contains filthy, putrid, or decomposed substance | Labeling is false or misleading |
| Prepared, packed, or held under insanitary conditions, or not made or held according to current good manufacturing practice | Missing required information, such as name and place of business or quantity of contents |
| Container is made of a poisonous or harmful substance | Lacks adequate directions (for an OTC drug) or the required "Rx only" statement (for a prescription drug) |
| Strength, quality, or purity differs from the official compendium or its labeling | Dangerous when used as the label suggests |
| Mixed or substituted with another substance | Imitation, or sold under another drug's name |
A drug stored outside its labeled conditions (for example, a vaccine left at room temperature overnight) may be adulterated because it was held in violation of good practices. A drug dispensed without a proper label is misbranded.
Utah rules
| Provision | Rule |
|---|---|
| § 58-17b-502(1)(c) | Misbranding or adulterating a drug or device, or selling, distributing, or dispensing an outdated, misbranded, or adulterated drug or device, is unprofessional conduct ($1,000–$5,000 for a first offense) |
| R156-17b-502(19) | Dispensing a medication discontinued by the FDA is unprofessional conduct |
| R156-17b-605(1) | Authorized staff must remove out-of-date legend drugs and controlled substances from inventory at regular intervals, according to the labeled beyond-use or expiration date |
| § 58-17b-602(5)(a)(viii) | The label must show a beyond-use date, and the patient should be counseled on the date after which the drug should not be used (R156-17b-610(3)(k)) |
| § 58-17b-103(3) | DOPL inspectors may take samples for analysis, temporarily seize, or box and seal drugs suspected of being adulterated, misbranded, or outdated, pending a hearing |
| § 58-17b-614(3) | The pharmacy must immediately report in writing any disaster, accident, or emergency that may affect drug purity or labeling |
| § 58-17b-501(4); § 58-17b-502(1)(d) | Buying or selling drugs marked "sample" or "not for resale" is unlawful and unprofessional conduct |
| § 58-17b-503 | Dispensed drugs returned from outside the pharmacy may not be redistributed except under the listed exceptions (Section 7.3) |
| R156-17b-615(7)(d), (11)(b) | Wholesalers must quarantine outdated, damaged, deteriorated, misbranded, adulterated, or opened products until they are destroyed or returned |
Recalls and market withdrawals
FDA classifies recalls by risk:
- Class I: reasonable probability of serious adverse health consequences or death.
- Class II: temporary or medically reversible effects, or a remote probability of serious harm.
- Class III: unlikely to cause adverse health consequences.
A pharmacy's recall procedure should:
- identify affected lots in inventory and any dispensed prescriptions;
- quarantine and stop dispensing affected stock;
- notify patients when the recall reaches the patient level; and
- return the product or document its destruction.
Class C wholesalers must have written procedures for recalls and withdrawals (R156-17b-615(15)(b)). The PIC is responsible for procurement policies and for drug disposal and distribution (R156-17b-603(3)(f)–(g)).
Suspect and illegitimate products (DSCSA)
Under the federal Drug Supply Chain Security Act (21 U.S.C. § 360eee et seq.), a dispenser must:
- buy and sell only with authorized trading partners (licensed or registered);
- receive the required transaction information and statements (and, under enhanced requirements, product identifiers), and keep them six years;
- when it has a suspect product (for example, counterfeit, diverted, stolen, or intentionally adulterated), quarantine it and promptly investigate; and
- if the product is illegitimate, notify FDA (Form FDA 3911) and immediate trading partners within 24 hours of that determination, and dispose of it appropriately.
Utah's rules define a counterfeit prescription drug by reference to federal law (R156-17b-102(15)). Utah's Charitable Prescription Drug Recycling Program requires eligible pharmacies to follow the DSCSA (§ 58-17b-905(2)(b)).
Decision checklist before dispensing
- Is the product within date, and will its beyond-use date cover the course of therapy?
- Was it stored within its labeled conditions? Check temperature logs for refrigerated items.
- Is it recalled, discontinued by FDA, or on hold?
- Did it come from an authorized trading partner with DSCSA documentation? Is anything suspect about the packaging?
- Is it a sample or labeled "not for resale"?
- Was it returned from outside the pharmacy without meeting an exception?
If any answer disqualifies the product, do not dispense it. Quarantine it and document what was done.
During an inspection, a DOPL investigator finds several stock bottles past their expiration dates on the dispensing shelf. What authority does the investigator have under Utah Code § 58-17b-103?
The investigator may temporarily seize, or box and seal, the suspect outdated drugs pending an adjudicative proceeding
The investigator must ignore expired stock unless a patient was harmed
The investigator may immediately destroy the pharmacy's entire inventory
The investigator may seize the drugs only with a DEA warrant
A pharmacist dispenses a product that FDA had discontinued from the market. How does Utah classify this?
Unlawful conduct punishable as a felony in every case
Unprofessional conduct under R156-17b-502(19)
Permissible if the patient signs a waiver
Not a violation if the product is still within its expiration date
A pharmacy's refrigerator failed overnight, and insulin sat above 8 °C for 14 hours. How should the pharmacist treat the affected insulin?
Sell it at a discount with a verbal warning to the patient
Dispense it normally, because insulin is stable at any temperature
Return it to active stock after it cools back down
Quarantine it, document the excursion, and consult the manufacturer's stability data before any dispensing, because a drug held outside proper storage conditions may be adulterated
A pharmacy determines that a product it received is illegitimate (counterfeit). Under the federal DSCSA, what must the dispenser do?
Notify only the Utah Board of Pharmacy within 30 days
Dispense the remaining units and report at the end of the month
Quarantine the product and notify FDA and immediate trading partners within 24 hours of the determination
Return the product to the wholesaler without any notice
Sections you finish are checked off in the contents.