If a doctor or veterinarian is allowed to dispense drugs to their patients without a pharmacy license, does the office or clinic where they dispense still need to register as a 'drug outlet' with the Oregon Board of Pharmacy?
Subject
Health Boards
Plain-English summary
Seven Oregon health licensing boards (Pharmacy, Nursing, Medicine, Naturopathic Examiners, Dentistry, Veterinary Medical Examining, and Optometry) jointly asked the AG a single question: if practitioners are exempt from needing a pharmacy license to dispense drugs to their patients (under ORS 689.225(1)), does the place where they dispense those drugs still have to register as a "drug outlet" with the Board of Pharmacy under ORS 689.305?
The AG separated the two questions and concluded the answer is yes.
ORS 689.225(1) is about who can practice pharmacy. It says you cannot practice pharmacy without a license, but it carves out physicians, dentists, veterinarians, osteopaths, and other healing-arts practitioners whose own licensing laws authorize them to dispense and administer drugs. That exemption only affects whether the practitioner needs a pharmacy license. It does not say anything about whether the office or clinic where the practitioner dispenses must register as a drug outlet.
ORS 689.305 separately requires "all drug outlets" to register annually with the Board of Pharmacy. ORS 689.335(1) prohibits operating an unregistered drug outlet. There are no exemptions in either provision.
So the AG turned to the harder question: are dispensing practitioners' offices "drug outlets"? The statutory definition in ORS 689.005(12) lists pharmacies, nursing homes, hospitals, retail stores, and similar facilities, and ends with "or other establishment with facilities located within or out of this state that is engaged in dispensing, delivery or distribution of drugs within this state." The AG concluded "establishment" was broad enough to cover a dispensing practitioner's office, especially when read alongside the 2005 amendment that added the same "or other establishment" language to the definition of "shopkeeper" in ORS 689.005(34) to clarify that nonprofits qualified as shopkeepers.
For the registration classification, the AG concluded these clinics fit the "retail drug outlet" classification (ORS 689.305(2)(a)). The definition (ORS 689.005(33)) covers "a place used for the conduct of the retail sale, administering or dispensing or compounding of drugs or chemicals." The AG read "retail" to apply to all the listed activities, meaning transfer for consideration to an ultimate consumer. A practitioner dispensing drugs to a patient for a fee fits.
The AG noted that a 2012 statute on physician assistant dispensing (Senate Bill 1565) explicitly required supervising physician organizations to register the dispensing facility as a drug outlet, which confirmed the legislature's understanding of how ORS 689.305 worked.
Currency note
This opinion was issued in 2013. Subsequent statutory amendments, court decisions, or later AG opinions may have changed the analysis. Treat this page as historical context, not current legal advice. Verify current law before relying on any specific rule, deadline, or remedy mentioned here.
Common questions
What is "the practice of pharmacy" in Oregon?
ORS 689.005(28)(b) defines it to include "the compounding, dispensing and labeling of drugs and devices." That is what triggers the pharmacy licensing requirement. ORS 689.225(1) carves practitioners out of the licensing requirement when their own licensing laws (medical, dental, veterinary, etc.) authorize them to dispense and administer drugs. So a doctor giving a patient a sample bottle of medicine does not need a pharmacist license, even though dispensing technically falls within "the practice of pharmacy."
Why register the office if the doctor is already separately licensed?
The drug outlet registration system serves a different purpose from individual licensing. Registration lets the Board of Pharmacy track every place where prescription drugs are dispensed, inspect facilities, regulate storage and security, and audit compliance with controlled-substance laws. The AG noted that "all drug outlets" must register and "no" outlet may operate without a certificate. The legislature did not write any exemption for dispensing practitioner sites.
What if drugs are given out for free?
The AG's analysis of "retail drug outlet" turned in part on transfer for consideration. A facility that dispensed drugs without consideration would not fit "retail," though it might still fall under another classification (such as a nonprofit "shopkeeper" or "nonprescription drug outlet"). The opinion reached only the registration requirement for places that dispensed for consideration.
Did the legislature ever say what "establishment" means?
No. The AG worked from the dictionary, the structure of ORS 689.005(12), and the parallel use of "establishment" in ORS 689.005(34)'s shopkeeper definition. The 2005 amendment that added "other establishment" to both provisions was tied to a specific concern (letting the Oregon Food Bank register as a drug outlet for donated nonprescription drugs), but the AG noted "the language that was enacted into law is much broader" than what the witness described. Citing Halperin v. Pitts: "[T]here is no more persuasive evidence of the intent of the legislature than the words by which the legislature undertook to give expression to its wishes."
What did the 2012 physician assistant law tell the AG?
Senate Bill 1565 (2012) required the supervising physician or physician organization to "register the facility from which the physician assistant will dispense drugs as a drug outlet with the State Board of Pharmacy under ORS 689.305." The AG noted that later statutes do not illuminate earlier intent, but cited the provision as showing the legislature's understanding that ORS 689.305 already required such facilities to be registered.
Are pharmacies still treated differently from clinic dispensaries?
Yes. The AG read ORS 689.005(33) as having two clauses. The first applies to all places used for retail sale, administering, dispensing, or compounding of drugs. The second applies to places "for the administering or dispensing of prescriptions and licensed by the board as a place wherein the practice of pharmacy may lawfully occur." Only the latter has to be a licensed pharmacy. A clinic dispensary fits the first clause without needing pharmacy licensure, but it still must register as a retail drug outlet.
Background and statutory framework
Oregon's pharmacy code sits in ORS chapter 689. ORS 689.151 gives the Board of Pharmacy authority to regulate the practice of pharmacy and issue licenses. ORS 689.225(1) prohibits anyone from practicing pharmacy without a license but exempts physicians, dentists, veterinarians, osteopaths, and other healing-arts practitioners when their own licensing laws authorize them to dispense and administer drugs.
ORS 689.305 is the drug outlet registration regime. ORS 689.305(1) requires "all drug outlets" to register annually. ORS 689.305(2)(a) lists five classifications: retail, institutional, manufacturing, wholesale, and nonprescription drug outlets. ORS 689.335(1) prohibits operation without a certificate.
Definitions are in ORS 689.005. "Drug outlet" (subsection 12) covers pharmacies, nursing homes, hospitals, family planning clinics, retail stores, wholesalers, manufacturers, mail-order vendors, and "other establishment with facilities located within or out of this state that is engaged in dispensing, delivery or distribution of drugs within this state." "Retail drug outlet" (subsection 33) is "a place used for the conduct of the retail sale, administering or dispensing or compounding of drugs or chemicals or for the administering or dispensing of prescriptions and licensed by the board as a place wherein the practice of pharmacy may lawfully occur."
The 2005 legislative amendment (Or Laws 2005, ch 313, § 11) added the "other establishment" language to both ORS 689.005(12) and ORS 689.005(34) (shopkeeper definition).
The interpretive method follows PGE v. BOLI (text and context first) and State v. Gaines (legislative history when useful). Tharp v. PSRB supplies the canon that the same word in related statutes is presumed to carry the same meaning.
Citations
- ORS 689.005(8), (10), (12), (20), (22), (26), (28)(b), (33), (34), (36)
- ORS 689.151; 689.225(1); 689.305; 689.315(4)(a); 689.335(1)
- Or Laws 2005, ch 313, § 11
- 2012 Senate Bill 1565
- PGE v. BOLI, 317 Or 606, 859 P2d 1143 (1993)
- State v. Gaines, 346 Or 160, 206 P3d 1042 (2009)
- Tharp v. PSRB, 338 Or 413, 110 P3d 103 (2005)
- Halperin v. Pitts, 352 Or 482, 287 P3d 1069 (2012)
Source
- Landing page: https://www.doj.state.or.us/oregon-department-of-justice/office-of-the-attorney-general/attorney-general-opinions/
- Original PDF: https://www.doj.state.or.us/wp-content/uploads/2013/02/op2013-1.pdf
Original opinion text
ELLEN F. ROSENBLUM
MARY H. WILLIAMS
Attorney General
Deputy Attorney General
DEPARTMENT OF JUSTICE
GENERAL COUNSEL DIVISION
February 6, 2013
[Addressed to the Executive Directors of the Boards of Nursing, Medicine, Pharmacy, Naturopathic Examiners, Dentistry, Veterinary Medical Examining, and Optometry]
Re: Opinion Request OP-2013-1
Dear Executive Directors:
Among other things, the State Board of Pharmacy (board) is responsible for regulating the practice of pharmacy in Oregon, which includes issuing licenses to persons to engage in the practice of pharmacy. ORS 689.151. The board is also responsible for issuing "certificates of registration" to "drug outlets." ORS 689.305. Pursuant to ORS 689.225(1), physicians, dentists, veterinarians, osteopaths and "other practitioners of the healing arts" do not need to obtain a license to engage in the practice of pharmacy to administer and dispense drugs to their patients if their own licensing laws authorize them to do so.
The pharmacy, nursing, dentistry, medical, naturopathic, and veterinary boards ask the following question concerning whether the exemption in ORS 689.225(1) affects the drug outlet registration requirement in ORS 689.305.
QUESTION
Are the practice sites of dispensing practitioners who are exempt from the requirement to obtain a license to practice pharmacy under ORS 689.225(1) subject to the "drug outlet" registration requirement imposed by ORS 689.305?
SHORT ANSWER
We conclude that ORS 689.225(1) does not exempt those practice sites from the drug outlet registration requirement. We also conclude, although the answer is not free from all doubt, that those sites are "drug outlets" subject to the registration requirement if drugs are dispensed for consideration from them.
DISCUSSION
A. Methodology
To answer the question, we must interpret several statutes in ORS chapter 689. The Oregon Supreme Court has established the following methodology for interpreting statutes: The goal is to determine the intent of the legislature by first examining the statute's text, in context, and, where appropriate, we also may also consult legislative history to the extent that it is helpful. PGE v. Bureau of Labor and Industries, 317 Or 606, 610, 859 P2d 1143 (1993); State v. Gaines, 346 Or 160, 171-73, 206 P3d 1042 (2009).
B. Scope of exception in ORS 689.225(1)
ORS 689.225(1) provides that:
A person may not engage in the practice of pharmacy unless the person is licensed under this chapter. Nothing in this section prevents physicians, dentists, veterinarians, osteopaths or other practitioners of the healing arts who are licensed under the laws of this state from dispensing and administering prescription drugs to their patients in the practice of their respective professions where specifically authorized to do so by law of this state.
ORS 689.151 gives the board authority to regulate and control the practice of pharmacy, including issuing licenses. A qualified applicant may obtain a license to practice pharmacy either by taking an examination or through reciprocity. ORS 689.151(1).
ORS 689.005 contains the definitions as used in chapter 689. Subsection (28)(b) of that statute defines the "practice of pharmacy" to include "[t]he compounding, dispensing and labeling of drugs and devices, except labeling by a manufacturer, packer or distributor of nonprescription drugs and commercially packaged legend drugs or devices." ORS 689.005(28)(b). "Dispense" or "dispensing" means "the preparation and delivery of a prescription drug pursuant to the lawful order of a practitioner in a suitable container appropriately labeled for subsequent administration to or use by a patient or other individual entitled to receive the prescription drug." ORS 689.005(8).
Read in that context, ORS 689.225(1) generally prevents a person from dispensing drugs unless the person has obtained, through examination or reciprocity, a license to engage in the practice of pharmacy under ORS 689.151(1). But ORS 689.225(1) specifies "[n]othing in this section prevents" Oregon-licensed practitioners of the healing arts who are authorized by their own licensing laws to dispense drugs from dispensing drugs in accordance with their own licensing laws. "Nothing in this section prevents" means nothing in ORS 689.225(1). ORS 689.225(1) prevents only engaging in the practice of pharmacy without having obtained a license and that license is obtained through examination or reciprocity under ORS 689.151(1). Stated another way, this language merely clarifies that ORS 689.225(1) does not require practitioners whose own licensing laws authorize them to dispense and administer prescription drugs to obtain a license under ORS 689.151(1).
ORS 689.225(1) does not say that the practice sites of those practitioners are exempt from registration. ORS 689.225(1) is concerned solely with the professional licensing of pharmacists. Other provisions in ORS 689 govern the registration of drug outlets. Specifically, ORS 689.305(1) provides that "[a]ll drug outlets shall annually register with the State Board of Pharmacy." ORS 689.335(1) states that "[n]o drug outlet designated in ORS 689.305 shall be operated until a certificate of registration has been issued to said facility."
We conclude that the legislature did not intend the exemption in ORS 689.225(1) to exempt the practice sites of dispensing practitioners from the drug outlet registration requirement.
The drug outlet registration requirement applies to "all" drug outlets and "no" outlet may operate without a certificate of registration. There are no exceptions. We turn to whether the practice sites of dispensing practitioners are "drug outlets" for purposes of the registration requirement.
C. Definition of drug outlet
ORS 689.005(12) defines a "drug outlet" as:
[A]ny pharmacy, nursing home, shelter home, convalescent home, extended care facility, drug abuse treatment center, penal institution, hospital, family planning clinic, student health center, retail store, wholesaler, manufacturer, mail-order vendor or other establishment with facilities located within or out of this state that is engaged in dispensing, delivery or distribution of drugs within this state.
There is no question that nursing homes, shelter homes, convalescent homes, extended care facilities, drug abuse treatment centers, penal institutions, hospitals, family planning clinics and student health centers are "drug outlets" subject to the registration requirement regardless of whether practitioners who are exempt from the licensing requirement under ORS 689.225(1) dispense drugs at those places. "Dispensing practitioner's offices" or "dispensing practitioner's clinics," however, are not specifically listed and, therefore, must fit within one of the more general types of listed "drug outlet."
The most general of those is "[a]ny * * * other establishment with facilities located within or out of this state that is engaged in dispensing, delivery or distribution of drugs within this state." The practice sites of dispensing practitioners are engaged in dispensing drugs in Oregon. The question is whether they are "establishments" for purposes of the statute. "Establishment" is not defined for purposes of ORS chapter 689 so we give it its plain meaning.
There are three potentially pertinent plain meanings of "establishment": (1) "something that has been established"; (2) "a more or less fixed and usually sizable place of business or residence together with all the things that are an essential part of it (as grounds, furniture, fixtures, retinue, employees)"; and, (3) "a public or private institution (as a school or hospital)." WEBSTER'S THIRD NEW INT'L DICTIONARY at 778 (2d ed 2002).
Another piece of relevant context is the use of the word "establishment" in a related statute in ORS chapter 689. Generally, when the legislature uses the same word in a related statute, we presume that it intends the same meaning. Tharp v. PSRB, 338 Or 413, 110 P3d 103 (2005). The legislature uses the term "establishment" in ORS 689.005(34), which defines "shopkeeper." A shopkeeper is defined as "a business or other establishment, open to the general public, for the sale or nonprofit distribution of drugs." That use of "establishment" is particularly pertinent not only because it is used in a related statute, but because the legislature added "other establishment" in that provision at the same time that it added "other establishment" to the definition in ORS 689.005(12). Or Laws 2005, ch 313, section 11.
In short, it is not possible to tell precisely what the legislature intended by "other establishment" as used in ORS 689.005(12), except that it appears to have been intended to encompass both businesses and nonprofit organizations. Although not free from doubt, we conclude that the legislature most likely used the term consistently with ORS 689.335(1), the provision imposing the prohibition on operating a drug outlet without a certificate, in the sense of a facility. Accordingly, "other establishment" most likely includes the facility from which a business or nonprofit organization dispenses, delivers or distributes drugs to Oregonians. The practice sites of dispensing practitioners fit within that definition and, therefore, are "drug outlets," and must annually register with the board pursuant to ORS 689.305(1).
D. Outlet Classification
ORS 689.305(2)(a) requires "[e]ach drug outlet" to apply for a certificate of registration in one or more of five listed classifications: (1) retail drug outlet; (2) institutional drug outlet; (3) manufacturing drug outlet; (4) wholesale drug outlet; or, (5) nonprescription drug outlet. Drug outlets must meet criteria established by the board to qualify for registration in a particular classification. ORS 689.305(3).
The only applicable classification is "retail drug outlet," which is defined as:
[A] place used for the conduct of the retail sale, administering or dispensing or compounding of drugs or chemicals or for the administering or dispensing of prescriptions and licensed by the board as a place wherein the practice of pharmacy may lawfully occur.
A dispensing practitioner's office or clinic fits within a place "used for the conduct of * * * dispensing * * * drugs" and also "for * * * dispensing prescriptions."
The AG concluded that "retail" applies to all the activities in the first clause for the purpose of imposing two requirements: (1) transfer for consideration; (2) and transfer directly to the ultimate consumer. That interpretation is consistent with the purpose of the provision, which is intended to distinguish a "retail drug outlet" from other types of drug outlets, such as "manufacturing" and "wholesale" drug outlets.
We conclude that the text and context suggest that "retail drug outlet" as defined in ORS 689.005(33) most likely includes all places used for dispensing drugs to an ultimate consumer for consideration, including the places where dispensing practitioners dispense medications to their patients for consideration.
E. Legislative History
Finally, we have examined the legislative history, but the history does not change our conclusions based on the text and context. The drug outlet registration requirement was enacted in 1979 as part Senate Bill 866 (1979), which was an overhaul and recodification of the pharmacy code.
The language "other establishment with facilities within or out of this state that is engaged in dispensing, delivery or distribution of drugs within this state" was not part of the original definition of "drug outlet", but was added to the definition in 2005 as a –A4 amendment to Senate Bill 512. One non-legislator witness testified before a House Committee that the amendment was a "technical amendment" needed to ensure that the Oregon Food Bank could be registered as a drug outlet. As discussed, the definition of "shopkeeper" also was amended at that time to include establishments other than businesses and the nonprofit distribution of drugs.
Although according to the testimony of one non-legislator witness, the reason for requesting the amendment was to ensure that the Oregon Food Bank qualified as a drug outlet, the language that was enacted into law is much broader. The Oregon Supreme Court recently reiterated that "[t]here is no more persuasive evidence of the intent of the legislature than the words by which the legislature undertook to give expression to its wishes." Halperin v. Pitts, 352 Or 482, 486, 287 P3d 1069 (2012).
Finally, we note that, in 2012, the legislature enacted Senate Bill 1565, concerning physician assistant dispensing. Section 2(2)(b)(D) of that bill requires the board to adopt rules that require "[t]he supervising physician or supervising physician organization that applies for dispensing authority for a physician assistant to * * * [s]ubmit to the board documentation showing that the supervising physician or supervising physician organization has registered the facility from which the physician assistant will dispense drugs as a drug outlet with the State Board of Pharmacy under ORS 689.305." Although that is a later-enacted statute and does not illuminate the intent of earlier enactments, we point it out merely to demonstrate that our conclusion that ORS 689.305 requires such facilities to be registered is consistent with the legislature's understanding of what ORS 689.305 requires.
F. Conclusion
We conclude that the practice sites of practitioners who dispense drugs for consideration to their patients in accordance with their own professional licensing laws, but who are not required under ORS 689.225(1) to obtain a license to engage in the practice of pharmacy from the board to do so, are "drug outlets" under ORS 689.005(12) and subject to the drug outlet registration requirement in ORS 689.305.
Sincerely,
[Steven A. Wolf]
Steven A. Wolf
Chief Counsel
General Counsel Division
SAW:nog/JUSTICE-#3968819