8.6 Prescription Labeling: Oregon Elements, Physical Description, Expiration Dating & Med Paks

Why this matters

Area 3.5 covers labeling of dispensed drugs. Oregon's label requirements come from ORS 689.505, ORS 689.515 and OAR 855-041-1130. Oregon requires a physical description of the drug on most labels and limits expiration dating in specific ways. Federal law adds the controlled-substance warning.

Required label elements for drugs dispensed to a patient (OAR 855-041-1130)

A prescriber may direct that the label not state the drug's name and quantity per unit (ORS 689.505(6)). The pharmacy then labels as the prescriber intended (ORS 689.515(8)).

Expiration dating (OAR 855-041-1130(10)–(11))

The expiration date on the label may not exceed:

• The date on the manufacturer's container, if the drug is dispensed in the manufacturer's container; or
• Otherwise, the earlier of the manufacturer's expiration date or one year from the date the drug was repackaged and dispensed.

A drug that will expire before the expected course of therapy ends must not be dispensed.

Federal controlled-substance labeling

For Schedule II–IV drugs dispensed to a patient, federal law requires the warning "Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed" (21 CFR 290.5). The label must also show the pharmacy name and address, serial number, date of initial filling, patient name, prescriber name, directions and cautionary statements (21 CFR 1306.14, 1306.24). Oregon's elements already cover most of these.

Dual-language and accessible labels

On request of the prescriber, patient or agent, the label must be in English plus one of Oregon's 14 languages, and must be compatible with any prescription reader provided (section 7.2).

Labels for repackaged drugs and patient med paks

• Repackaged drugs for later dispensing (OAR 855-041-1135) must show:
  • The brand name, or the generic name and manufacturer.
  • The strength and the lot number.
  • The manufacturer's expiration date, or an earlier date the pharmacist judges preferable. An internal control number may link to the manufacturer and lot. Containers must meet USP standards. A technician or intern who labels repackaged drugs, or returns drugs to stock, needs pharmacist verification documented.
• Customized patient medication packages ("med paks," OAR 855-041-1140) hold several solid oral drugs for one patient. The label shows:
  • The patient's name and a serial number.
  • For each drug: its name, strength, physical description and quantity, plus its directions, cautionary statements and prescriber.
  • Storage instructions, and the date of preparation and beyond-use date, which may be no later than 60 days from preparation.
  • The dispenser's name, address and phone. Med paks use Class B moisture-permeation containers, meet PPPA requirements and come with package inserts or educational material. The pharmacist checks the drugs' compatibility.

Other labeling situations

• Generic substitution: the label names the drug dispensed, or the generic name plus the manufacturer (ORS 689.515(7)).
• Nasal opioid antagonists dispensed by a pharmacist prescriber are exempt from some labeling requirements (ORS 689.813; OAR 855-115-0350).
• Compounded preparations: labels follow USP 795/797 and OAR 855-183 for preparation, and OAR 855-041 for dispensing.
• Practitioner dispensing: NPs, CNSs and PAs who dispense must label like pharmacies (ORS 678.390(5); ORS 677.511).

Exam scenario

An Oregon pharmacy dispenses 30 amlodipine 5 mg tablets from a bulk bottle expiring in 8 months, as a generic, in a new amber vial. The label must include all the elements above, the manufacturer's name (generic dispensed), a physical description such as "white, round, imprint ABC 5," and an expiration date no later than the manufacturer's date 8 months out (earlier than one year). If the same drug were dispensed in unit-dose blister packaging, the physical description could be omitted.