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
Green check means up to date. Up to date

Current through early 2024

§ 689.522’s source at oregon​.gov