ORS 689.522
Substitution of biological products for prescribed biological products

  • rules

(1)

A pharmacy or pharmacist filling a prescription order for a biological product may not substitute a biological product for the prescribed biological product unless:

(a)

The substitute biological product has been determined by the United States Food and Drug Administration to be interchangeable with the prescribed biological product;

(b)

The prescribing practitioner has not designated on the prescription that substitution is prohibited;

(c)

The patient for whom the biological product is prescribed is informed of the substitution in a manner reasonable under the circumstances; and

(d)

The pharmacy or pharmacist retains a record of the substitution for a period of not less than three years.

(2)

The State Board of Pharmacy shall, on a website maintained by the board, maintain a link to the current list, if available, of biological products determined by the United States Food and Drug Administration to be interchangeable.

(3)

Intentionally left blank —Ed.

(a)

For purposes of this section, the board shall adopt by rule definitions for the terms “biological product” and “interchangeable.”

(b)

The rule defining the term “biological product” must be consistent with 42 U.S.C. 262(i)(1).

(c)

The rule defining the term “interchangeable” must:

(A)

For biological products licensed under the Public Health Service Act, define the biological products that may be substituted for other biological products as having been determined by the United States Food and Drug Administration as meeting the standards in 42 U.S.C. 262(k)(4); and

(B)

For biological products approved by the United States Food and Drug Administration under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 301 et seq., define the biological products that may be substituted for other biological products as having been determined by the United States Food and Drug Administration as therapeutically equivalent as set forth in the latest edition or supplement of the Approved Drug Products with Therapeutic Equivalence Evaluations. [2013 c.342 §2; 2013 c.342 §4; 2016 c.43 §§1,2]

Source: Section 689.522 — Substitution of biological products for prescribed biological products; 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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