ORS 689.515
Regulation of generic drugs

  • substitutions
  • rules

(1)

As used in this section unless the context requires otherwise:

(a)

“Brand name” means the proprietary or trade name selected by the manufacturer and placed upon a drug, its container, label or wrapping at the time of packaging.

(b)

“Dosage form” means the physical formulation or medium in which the product is intended, manufactured and made available for use, including but not limited to tablets, capsules, oral solutions, aerosols, ointments, inhalers and suppositories, and the particular form of which utilizes a specific technology or mechanism to control, enhance or direct the release, targeting, systemic absorption or other delivery of a dosage regimen in the body.

(c)

“Generic name” means the official title of a drug or drug ingredients published in the latest edition of the official Pharmacopoeia, Homeopathic Pharmacopoeia or Formulary.

(d)

“Substitute” means to dispense without the prescriber’s express authorization a different drug product in place of the drug ordered or prescribed.

(e)

“Therapeutically equivalent” means drugs that are approved by the United States Food and Drug Administration for interstate distribution and the Food and Drug Administration has determined that the drugs will provide essentially the same efficacy and toxicity when administered to an individual in the same dosage regimen.

(2)

Except as limited by subsections (3) and (5) of this section, unless the purchaser instructs otherwise, a pharmacist may substitute as follows:

(a)

A drug product with the same generic name in the same strength, quantity, dose and dosage form as the prescribed drug which is, in the pharmacist’s professional opinion, therapeutically equivalent.

(b)

When the prescriber is not reasonably available for consultation and the prescribed drug does not utilize a unique delivery system technology, an oral tablet, capsule or liquid form of the prescribed drug so long as the form dispensed or administered has the same strength, dose and dose schedule and is therapeutically equivalent to the drug prescribed.

(3)

A practitioner may specify in writing, by a telephonic communication or by electronic transmission that there may be no substitution for the specified brand name drug in a prescription.

(4)

A pharmacy shall post a sign in a location easily seen by patrons at the counter where prescriptions are dispensed or administered stating that, “This pharmacy may be able to substitute a less expensive drug which is therapeutically equivalent to the one prescribed by your doctor unless you do not approve.” The printing on the sign must be in block letters not less than one inch in height. If the pharmacist has reasonable cause to believe that the purchaser cannot read the sign or comprehend its content, the pharmacist shall endeavor to explain the meaning of the sign.

(5)

A pharmacist may substitute a drug product under this section only when there will be a savings in or no increase in cost to the purchaser.

(6)

If the practitioner prescribes a drug by its generic name, the pharmacist shall, consistent with reasonable professional judgment, dispense or administer the lowest retail cost, effective brand which is in stock.

(7)

Except as provided in subsection (8) of this section, when a pharmacist dispenses a substituted drug as authorized by subsection (2) of this section, the pharmacist shall label the prescription container with the name of the dispensed drug. If the dispensed drug does not have a brand name, the pharmacist shall label the prescription container with the generic name of the drug dispensed along with the name of the drug manufacturer.

(8)

A prescription dispensed by a pharmacist must bear upon the label the name of the medication in the container or shall be labeled as intended by the prescriber.

(9)

The substitution of any drug by a pharmacist or the pharmacist’s employer pursuant to this section does not constitute the practice of medicine.

(10)

A substitution of drugs made by a pharmacist or the pharmacist’s employer in accordance with this section and any rules that the State Board of Pharmacy may adopt thereunder does not constitute evidence of negligence if the substitution was made within reasonable and prudent practice of pharmacy or if the substituted drug was accepted in a generally recognized formulary or government list.

(11)

Failure of a practitioner to specify that no substitution is authorized does not constitute evidence of negligence unless the practitioner knows that the health condition of the patient for whom the practitioner is prescribing warrants the use of the brand name drug product and not the substituted drug. [1979 c.777 §35; 1983 c.402 §4; 1985 c.565 §110; 1987 c.108 §5; 1989 c.706 §22; 1991 c.734 §76; part renumbered 689.854 (Civil penalty for violation of ORS 689.515) and 689.857 in 1991; 1993 c.534 §1; 1993 c.571 §14; 1999 c.350 §5; 2001 c.589 §1; 2001 c.623 §7a; 2009 c.326 §4]

Source: Section 689.515 — Regulation of generic drugs; substitutions; rules, https://www.­oregonlegislature.­gov/bills_laws/ors/ors689.­html.

689.005
Definitions
689.025
Policy
689.035
Short title
689.045
Severability
689.115
Membership
689.135
General powers of board
689.139
State Board of Pharmacy Account
689.145
Enforcement powers of board
689.151
Board control over licensing, standards and discipline
689.153
Continuing authority of board upon lapse, suspension, revocation or voluntary surrender of license or certificate
689.155
Authority of board over medications, drugs, devices and other materials
689.165
Officers
689.175
Compensation of board members and executive director
689.185
Meetings
689.195
Employees
689.205
Rules
689.207
Authority of board to require fingerprints
689.225
License requirement
689.255
Qualifications for licensure by examination
689.265
Qualifications for licensure by reciprocity
689.275
Renewal of licenses
689.285
Continuing education
689.295
Practice of clinical pharmacy
689.305
Registration of drug outlets
689.315
Application
689.325
Required reports
689.335
Certificate required
689.405
Grounds for discipline
689.445
Penalties and reinstatement
689.455
Duty to report suspected violations and prohibited conduct
689.486
When license required
689.490
Board to establish licensing system
689.495
Provision of licensing information
689.497
Report required upon termination of pharmacy technician
689.499
Pharmacy technician specialized education program
689.503
Licensing of pharmaceutical representatives
689.505
Labeling requirements
689.508
Prescription records
689.515
Regulation of generic drugs
689.522
Substitution of biological products for prescribed biological products
689.524
Approval of coverage for biological product
689.525
Out-of-state prescriptions
689.527
Prohibited practices
689.532
Complimentary samples
689.555
Agricultural drugs and certain other substances
689.557
Disposal of marijuana item left at retail drug outlet
689.561
Prescription readers
689.564
Language requirements for prescription drug labels
689.605
Power to dispense drugs from hospital pharmacies, drug rooms and penal institutions
689.615
Display of certificate or license
689.635
Dispensing according to naturopathic formulary
689.645
Vaccines, patient care services, drugs and devices
689.649
Public Health and Pharmacy Formulary Advisory Committee
689.655
Power to administer drugs and devices
689.661
Power to perform tests and examinations related to federally cleared analytes
689.681
Opiate overdose
689.682
Prescription of naloxone
689.684
Administration of naloxone by certain persons
689.686
Notice of availability of naloxone
689.689
Prescription and administration or dispensation of certain contraceptives
689.692
Dispensation of prescription drug containing cannabinoids
689.696
Prescription and dispensation of emergency refills of insulin
689.700
Telepharmacy
689.704
Preexposure and post-exposure antiretroviral therapies
689.770
Definitions for ORS 689.770 to 689.780
689.772
Establishment of program
689.774
Rules
689.776
Inspection
689.778
Eligibility
689.780
Immunity
689.832
Civil penalties
689.854
Civil penalty for violation of ORS 689.515
689.995
Criminal penalties
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