AGO 1987 No. 2 - Jan 12 1987
STATE BOARD OF PHARMACY ‑- AUTHORITY TO REGULATE ‑- REGISTRATION AND LICENSING REQUIREMENTS OF DRUG MANUFACTURERS, REPRESENTATIVES OR AGENTS REGARDING LEGEND DRUGS AND CONTROLLED SUBSTANCES
(1) The Washington State Board of Pharmacy has the statutory authority to regulate the distribution of legend drugs and controlled substance samples by drug manufacturers or their representatives.
(2) The State Board of Pharmacy may require the registration or licensing of drug manufacturers alone with regard to the distribution of controlled substances. Similarly, drug manufacturers of legend drugs within the state and wholesalers alone are required to obtain a license from the State Board of Pharmacy.
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January 12, 1987
Ms. Barbara A. Vanderkolk
Chair, State Board of Pharmacy
319 East Seventh Avenue, FF-21
Olympia, Washington 98504
Cite as: AGO 1987 No. 2
Dear Ms. Vanderkolk:
By letter previously acknowledged, you asked for our opinion on two questions which we paraphrase as follows:
1. Does the Washington State Board of Pharmacy have statutory authority to regulate the distribution of legend drug and controlled substance samples by drug manufacturers or their representatives?
2. May the Washington State Board of Pharmacy require the registration or licensing of drug manufacturers or their representatives or agents, prior to their distribution of legend drug or controlled substance samples in this state?
We answer your first question in the affirmative and the second question in the manner set forth in our analysis. [[Orig. Op. Page 2]]
It is our understanding that it is a common practice for drug manufacturers to employ representatives who visit health care practitioners, such as physicians and dentists, for the purpose of promoting the health care practitioner to utilize or prescribe the manufacturer's drug products in the treatment of patients. This promotion can include providing the health care practitioner with a free supply of the drug product for administration or dispensing to patients. These drugs are intended to be given to patients without charge and can include drugs that can be sold without a prescription as well as drugs that require a prescription or are controlled substances. These drugs are generally packaged as "physician's samples" and are the sample drugs referred to in your questions.
Your first question inquires about the authority of the Washington State Board of Pharmacy (Board) as it relates to regulation of the distribution of legend drugs and controlled substances by drug manufacturers or their salespeople. The general statutory authority of the Board is contained in chapter 18.64 RCW. Additionally, the Legislature has enacted separate statutes dealing specifically with "legend drugs" (chapter 69.41 RCW) and with "controlled substances" (chapter 69.50 RCW, the Uniform Controlled Substances Act).1/ By way of general powers, the Board is empowered to "[r]egulate the practice of pharmacy and administer and enforce all laws placed under its jurisdiction." RCW 18.64.005(1). The definition of "practice of pharmacy" at RCW 18.64.011(11)2/ deals [[Orig. Op. Page 3]] specifically with the regular work performed by pharmacists and not with manufacture or distribution of drugs by companies producing drugs for sale in this state. We turn, therefore, to the laws placed under the jurisdiction of the board to determine if they authorize the regulation of distribution of drug samples.
There is no statutory provision under chapters 18.64, 69.41, or 69.50 RCW that specifically grants the Board authority to regulate the distribution of sample drugs by drug manufacturers. If the Board has the authority to so regulate, it must be gained from statutes dealing with its general regulatory powers.
RCW 18.64.005(11) authorizes the Board to adopt rules for:
the dispensing,distribution, wholesaling, and manufacturing of drugs and devices and the practice of pharmacy for the protection and promotion of the public health, safety, and welfare.
"Distribute" means the delivery of a drug or device other than by administering or dispensing. RCW 18.64.011(17). "Delivery" means the transfer from one person to another of a drug. RCW 18.64.011(15). The distribution of drug samples to health care practitioners by drug manufacturers or their representatives falls within the statutory definitions of "distribute" and "deliver." Therefore, we conclude that the Board has statutory [[Orig. Op. Page 4]] authority, under RCW 18.64.005(1) and (11), to promulgate rules regarding the distribution of drug samples by drug manufacturers or their representatives.3/ Additional statutory provisions pertaining to the authority of the Board are found in chapters 69.41 RCW and 69.50 RCW. Regarding specific rulemaking authority, RCW 69.50.301 provides:
The state board of pharmacy may promulgate rules and charge reasonable fees of not less than ten dollars or more than fifty dollars relating to the registration and control of the manufacture, distribution, and dispensing of controlled substances within this state.
This statute also allows the promulgation of rules regarding the distribution4/ of drugs, specifically controlled substances.
In a previous opinion, this office recognized the authority of the Board to "adopt rules concerning the dispensing of both legend drugs and controlled substances by whatever persons, pharmacists or otherwise, as are authorized to do so." AGO 1983 No. 12, at 7. As we noted in that opinion, "[r]ule‑making authority properly delegated to a state agency is to be liberally construed." AGO 1983 No. 12, at 7, (citing Spry v. Miller, 25 Wn.App. 741, 745, 610 P.2d 931 (1980)).
The provisions of RCW 18.64.005(11) and 69.50.301 delegate authority to the Board to promulgate rules regarding the distribution and delivery of legend drugs and controlled substances within this state. Liberally construing that power, it is our opinion that such authority extends to the regulation of the distribution of legend drug and controlled substance samples by [[Orig. Op. Page 5]] drug manufacturers or their representatives and, accordingly, we answer your first question in the affirmative.5/ We turn now to your second question, which is repeated here for ease of reference:
May the Washington State Board of Pharmacy require the registration or licensing of the drug manufacturers or their representatives or agents prior to their distribution of legend drug or controlled substance samples in this state.?
Turning first to that portion of your question dealing with "controlled substances," we note that chapter 69.50 RCW, the Uniform Controlled Substances Act, contains specific statutory provisions regarding registration. RCW 69.50.302(a) provides:
Every person who manufactures, distributes, or dispenses any controlled substance within this state or who proposes to engage in the manufacture, distribution, or dispensing of any controlled substance within this state, must obtain annually a registration issued by the state board of pharmacy in accordance with its rules.
It is clear that every controlled substance manufacturer and distributor must register annually with the Board in accordance with rules the Board adopts governing such registration.
Your question, however, also deals with the distribution of controlled substance samples by manufacturers' representatives. RCW 69.50.302(c)(1) states:
The following persons need not register and may lawfully possess controlled substances under this chapter; [[Orig. Op. Page 6]]
(1) an agent or employee of any registered manufacturer, distributor, or dispenser of any controlled substance if he is acting in the usual course of his business or employment: PROVIDED, That this exemption shall not include any agent or employee distributing sample controlled substances to practitioners without an order;
This statute provides that agents or employees of registered manufacturers or distributors need not register with the Board. The exception in the proviso requires registration if samples of controlled substances are distributed without an order. Chapter 69.50 RCW does not contain a definition of the word "order." However, RCW 69.50.307 requires that certain controlled substances shall be distributed only pursuant to an "order form." It is a generally recognized principle of statutory construction that the language of a statute must be read in context with the entire statute and construed consistently with its general purpose. Wilson v. Lund, 74 Wn.2d 945, 447 P.2d 718(1968). Therefore, we believe that the term "order" referred to in RCW 69.50.302(c)(1) refers to an order form completed by the physician or health care practitioner requesting samples of controlled substances from a manufacturer's representative. Consistent with this conclusion, RCW 69.50.308(d) requires that an order form from a practitioner must be issued in good faith for a legitimate medical purpose.
We conclude that the Board does not have statutory authority to require registration of agents or employees of registered manufacturers or distributors who distribute samples in the course of their employment, unless such samples are to be distributed without an order of a practitioner. Conversely, registration may be required if the salesperson distributes sample controlled substances without a practitioner's order.
We now turn to the second portion of your question dealing with the distribution of legend drugs. Chapter 69.41 RCW, governing legend drugs, does not contain any registration or licensing requirements. RCW 18.64.045 does require manufacturers, who manufacture drugs within the state of Washington, to obtain a license issued by the Board. Further, RCW 18.64.046 requires the owner of each place of business that sells legend drugs and nonprescription drugs at wholesale to obtain a license from the Board. The only statutes that deal specifically with registration are in the Controlled Substances Act. Except for the Controlled Substances Act, none of these statutes require licensing or registration of manufacturers' or wholesalers' agents or employees. [[Orig. Op. Page 7]]
As we stated in our answer to your first question, the Board does have statutory authority to promulgate rules regarding distribution and delivery of drugs within this state. To determine legislative intent as to a portion of a statute, that portion must be considered in relation to the entire statute and in light of the purpose and objectives of the entire enactment. Crippen v. Pulliam, 61 Wn.2d 725, 380 P.2d 475 (1963). In determining the intent of a statute all statutes relating to the same subject should be read as one law and given a harmonious interpretation. In re Estates of Donnelly, 81 Wn.2d 430, 502 P.2d 1163 (1972).
It is our opinion that the general statutory authority of the Board to adopt regulations regarding the distribution and delivery of drugs does not give the Board the authority to adopt rules requiring the registration or licensing of out-of-state drug manufacturers, their employees or agents.6/
When enacting chapter 18.64 RCW, the Legislature did not expressly require the licensing of agents and employees, as it did for manufacturers and wholesalers. Where a statute specifically designates things or classes of things on which it operates, the inference arises that all things or classes omitted from it were intentionally omitted by the legislature. Washington Natural Gas Co. v. Public Util. Dist. 1, 77 Wn.2d 94, 459 P.2d 633 (1969). Thus, we infer that the Legislature intentionally omitted agents and employees from licensing requirements.
Our opinion is strengthened by the fact that chapter 69.50 RCW, enacted in 1971, specifically addresses the registration of agents and employees distributing controlled substances. Chapter 69.41 RCW, governing legend drugs, was enacted in 1973. When creating a new statute, the legislature is presumed to be familiar with its prior enactments. Hopp v. Oroville Sch. Dist. 410, 31 Wn.App. 184, 639 P.2d 872 (1982). Had the legislature wished to require registration of out-of-state manufacturers, their agents and employees, prior to distribution of sample legend drugs, we believe that it would have so stated. We therefore conclude that the Board may not require the registration or licensing of out-of-state drug manufacturers, their agents or representatives prior to their distribution of legend drug samples.
We therefore answer your second question as set forth in the foregoing analysis. [[Orig. Op. Page 8]]
We trust that the foregoing will be of assistance to you.
Very truly yours,
KENNETH O. EIKENBERRY
MEREDITH WRIGHT MORTON
Assistant Attorney General
*** FOOTNOTES ***
1/"'Legend drugs' means any drugs which are required by any applicable federal or state law or regulation to be dispensed on prescription only or are restricted to use by practitioners only." RCW 18.64.011(6). The term "legend drugs" is also defined in RCW 69.41.010(8) (in the chapter governing legend drugs) as "any drugs which are required by state law or regulation of the state board of pharmacy to be dispensed on prescription only or are restricted to use by practitioners only." RCW 18.64.011(7) defines "controlled substance" as "a drug or substance, or an immediate precursor of such drug or substance, so designated under or pursuant to the provisions of chapter 69.50 RCW."
2/"'Practice of pharmacy' includes the practice of and responsibility for: Interpreting prescription orders; the compounding, dispensing, labeling, administering, and distribution of drugs and devices; the monitoring of drug therapy and use; the initiating or modifying of drug therapy in accordance with written guidelines or protocols previously established and approved for his or her practice by a practitioner authorized to prescribe drugs; the participating in drug utilization reviews and drug product selection; the proper and safe storing and distributing of drugs and devices and maintenance of proper records thereof; the providing of information on legend drugs which may include, but is not limited to, the advising of therapeutic values, hazards, and the uses of drugs and devices."
3/In so concluding, we note that any such rules promulgated by the Board must be for the protection and promotion of the public health, safety and welfare as required by RCW 18.64.005(11).
4/The terms "distribute" and "delivery" are again defined in chapter 69.50 RCW and are virtually identical to the definitions contained in chapter 18.64 RCW except that "delivery" under RCW 69.50.101(f) relates specifically to the delivery of controlled substances.
5/ It should be noted that there is a proviso in RCW 69.41.030 which renders this statute (which prohibits the sale, delivery or possession of a legend drug without a prescription or order) inapplicable to drug wholesalers, manufacturers, their agents and employees. This statute only removes drug manufacturers, wholesalers, and their representatives from potential criminal liability under RCW 69.41.070, and, in our opinion, does not preclude the Board from regulating distribution and delivery.
6/Drug manufacturers manufacturing within this state may be licensed under RCW 18.64.045.