______________________________________ 

______________________________________________________________________________ 

OFFICE OF THE ATTORNEY GENERAL
 State of California
 

JOHN K. VAN DE KAMP
 Attorney General
 

OPINION : 

: No. 89-1101 

of : 

: APRIL 18, 1990 

JOHN K. VAN DE KAMP : 

Attorney General : 

: 

CLAYTON P. ROCHE : 

Deputy Attorney General : 

: 

THE CALIFORNIA BOARD OF PHARMACY has requested an opinion on the

following questions concerning Business and Professions Code section 4046, subdivision (c)(1),

which provides that neither the California Pharmacy Law nor any other law shall be construed to

prohibit a registered pharmacist from furnishing to a prescriber a reasonable quantity of compounded

medication for prescriber office use: 

(1) Does "reasonable quantity" mean any quantity requested by the prescriber as long

as there is some medical basis for the use? 

(2) Does "compounded medication" include medication which the pharmacy

repackages but does not reformulate or admix? 

(3) Does "prescriber office use" include drugs which the prescriber dispenses to

patients for administration outside the prescriber's office or clinic? 

CONCLUSIONS 

As used in Business and Professions Code section 4046, subdivision (c)(1), which

provides that neither the California Pharmacy Law nor any other law shall be construed to prohibit

a registered pharmacist from furnishing to a prescriber a reasonable quantity of compounded

medication for office use: 

(1) "Reasonable quantity" means the amount of medication an ordinarily prudent

pharmacist would believe likely to be used or dispensed by a physician in the particular

circumstances of that physician, based on all the facts known to or which should reasonably be

known to the pharmacist. 

(2) "Compounded medication" does include medication which the pharmacy

repackages but does not reformulate or admix. 

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(3) "Prescriber office use" does include drugs which the prescriber dispenses to

patients for administration outside the prescriber's office or clinic. 

ANALYSIS 

The California Pharmacy Law is found in section 4000 et seq. of the Business and

Professions Code.1 In this opinion we are asked to construe section 4046 of that law. That section 

was added to the Pharmacy Law in 1981 by Chapter 989, Statutes of 1981. Specifically we are 

asked to interpret subdivision (c)(1) thereof, which provides: 

"(c) Neither this chapter nor any other provision of law shall be construed to

prohibit a registered pharmacist from: 

"(1) Furnishing to a prescriber a reasonable quantity of a

compounded medication for prescriber office use." 

Specifically we are asked (1) whether a "reasonable quantity" of a medication as used in this

subdivision is determined solely by the medical needs of the prescriber's patients or is otherwise

limited; (2) whether a "compounded medication" is solely one which is reformulated or admixed,

or whether it also may include medications which are repackaged by a pharmacist for the prescriber;

and (3) whether "for prescriber office use" is to be restricted to the administration of supplied

medications in the prescriber's office or clinic, or whether it also may include medications which are

dispensed to the prescriber's patients for home use. 

Preliminarily we note that the introductory language to subdivision (c) is cast in

negative terms giving rise to two possible interpretations. One is that subdivision (c) is merely a rule

of construction and as such is intended to merely clarify the law that the acts enumerated therein

were already allowed in 1981 under then existing law. The second is that the subdivision (c) was

intended to be substantive in nature and accordingly the section was intended to affirmatively

authorize the acts enumerated therein. We believe that the later construction is the one which 

comports with legislative intent.2 

Accordingly, in construing the meaning of subdivision (c) of section 4046 we look

to the language of the subdivision as indicative of what the Legislature intended. (Moyer v. 

1

All section references as to the Business and Professions Code unless otherwise indicated. 

2

Although a reasonable argument can be made that at least as to subdivision (c)(1) the Pharmacy

Law already allowed pharmacists to provide prescribers with a reasonable amount of any medication

for their office use when subdivision 4046 was enacted (see pre-1981 §§ 4034, 4050, 4051 and 4227

and § 26693 of the Health & Saf. Code, a provision of the Sherman Food, Drug And Cosmetics

Law), we reach our conclusion as to the construction of subdivision (c) of section 4046 for two main 

reasons. First, our examination of the legislative history of the law disclosed that the perception in

the Legislature appears to have been that affirmative authority was needed for all the pharmaceutical 

functions enumerated therein. Secondly, some of the additional enumerated functions in subdivision

(c) were clearly not authorized under the terms of the pre-1981 Pharmacy Law (e.g., monitoring

drug therapy by pharmacists in hospitals, including ordering and evaluating laboratory tests.) 

2. 89-1101
 
 

 

Workmen's Comp. Appeals Bd. (1973) 10 Cal.3d 22, 230; Brown v. Kelly Broadcasting Co. (1989)

48 Cal.3d 711, 724.)3 

1. "Reasonable Quantity" 

The first question presented for resolution is whether "reasonable quantity" as used

in section 4046, subdivision (c)(1) means any quantity requested by the prescriber as long as there

is some medical basis for the use. 

"Reasonable" is defined in Webster's Third New International Dictionary

(Unabridged Edition, 1976), at page 1892 as: 

". . . being in agreement with right thinking or right judgment: not conflicting

with reason: not absurd: not ridiculous . . . b: being or remaining within the bounds 

of reason: not extreme: not excessive . . ." 

In applying this definition to what constitutes a "reasonable quantity of a 

compounded medication for prescriber office use" we believe we must examine the question both

from the perspective of the prescriber and the pharmacist. 

As to the prescriber, we believe that section 4051 of the Pharmacy Law is most 

pertinent. That section presently reads as material herein: 

"(a) No prescriber shall dispense drugs or dangerous devices to patients in

his or her office or place of practice unless all of the following conditions are met: 

"(1) The drugs or dangerous devices are dispensed to the prescriber's own

patient and the drugs or dangerous devices are not furnished by a nurse or attendant. 

"(2) The drugs or dangerous devices are necessary in the treatment of the

condition for which the prescriber is attending the patient. 

"(3) The prescriber does not keep a pharmacy, open shop, drugstore,

advertised or otherwise, for the retailing of drugs or dangerous devices or poisons.[4

] 

3

A construction of section 4046 as an affirmative authorization for subdivision (c) pharmaceutical

functions also nullifies any suggestion that this subdivision constitutes an exception to the other

provision of the Pharmacy Law and as such should by narrowly construed. (See, e.g., City of

National City v. Fritz (1949) 33 Cal.2d 635, 636.) 

4

Pharmacy is defined in section 4035 of the Business and Professions Code as follows: 

"Pharmacy is an area, place, or premises in which he profession of pharmacy

is practiced and where prescriptions are compounded. 'Pharmacy' includes, but is not

limited to, any area, place, or premises described in a permit issued by the board by

reference to plans filed with and approved by the board wherein controlled

substances or dangerous drugs or dangerous devices, as they are herein defined, are

stored, possessed, prepared, manufactured, derived, compounded, or repackaged, and

from which the controlled substances or dangerous drugs or dangerous devices are

furnished, sold, or dispensed at retail. . . ." 

3. 89-1101
 
"(4) The prescriber fulfills all of the labeling requirements imposed upon

pharmacists by Section 4047.5, all of the recordkeeping requirements of good

pharmaceutical practice, including the use of child-proof containers. 

"(5) The prescriber does not use a dispensing device unless he or she

personally owns the device and the contents of it and personally dispenses the drugs

or dangerous devices to the patient packaged, labeled, and recorded in accordance

with paragraph (4). 

"(b) The Medical Board of California and the Board of Osteopathic

Examiners shall have authority with the Board of Pharmacy to assure compliance

with this section, and those boards are specifically charged with the enforcement of

this chapter with respect to their respective licensees. . . ." 

Although the term "dispense" is defined in section 4049 to mean "the furnishing of

drugs upon a prescription from a physician, dentist, podiatrist, or veterinarian", "dispense" as used

in this section would of necessity have a more general meaning, that is, to furnish. A physician

would not write a prescription for a drug that he or she was personally supplying a patient. (See also

prior version of § 4051 (Stats. 1965, ch. 1822, § 8) where the term "furnishing" was used.) 

Given the fact that section 4051 contemplates that a physician may furnish his or her

patients with drugs necessary to treat patients, with certain express limitations, we construe the term

"reasonable quantity" as used in section 4046, subdivision (c)(1) as follows. We believe that this 

subdivision requires a pharmacist who furnishes a prescriber with a "compounded medication" to

exercise his or her best judgment as to whether the quantity of the drug is appropriate considering

a number of factors. These include (1) the pharmacist's knowledge of the use of the compounded

medication by physicians generally in the area; (2) the size and nature of the physician's practice;

(3) the shelf life of the medication; and (4) the reserve supply a physician would need to have in his

or her office to supply his patients needs pending the time a new supply could be ordered and

delivered. 

From the pharmacist's perspective, we believe that experience and judgment will

indicate what is "reasonable" and conversely what is "extreme" or "excessive" as to particular

practitioners. Should the amount requested appear excessive to the pharmacist as to a particular

practitioner, then the pharmacist must inquire as to the reasons which would justify a need for the

quantity sought. If the pharmacist is not satisfied with the reasons given, he or she must decline to

furnish more than what his or her judgment dictates would be needed for the particular prescriber's

practice. (Cf. 16 Cal. Code Regs. § 1761, pharmacists not to compound or dispense uncertain or

erroneous prescriptions; see also, generally, Murphy v. E.R. Squibb & Sons, Inc. (1985) 40 Cal.3d

672, 677-679 regarding the professional role of a pharmacist, including that "on occasion he

provides doctors as well as patients with advice" regarding medications.) 

Accordingly, on the first question we conclude that "reasonable quantity" as used in

section 4046, subdivision (c)(1), means the amount of medication an ordinarily prudent pharmacist

would believe likely to be used or dispensed by a physician in the particular circumstances of that

physician, based on all the facts known to or which should reasonably be known to the pharmacist. 

The law does not define "open shop" or "drugstore." 

4. 89-1101
 
2. "Compounded Medication" 

The second question presented is whether "compounded medication" as used in

section 4046, subdivision (c)(1), includes medication which the pharmacy repackages but does not

reformulate or admix. We conclude that it does include such medications. 

It has been suggested that subdivision (c) does not include medication which a 

pharmacy merely repackages and then provides to a prescriber for office use. This suggestion arises

primarily from the fact that the verb to compound means ". . . 1: to put together (as elements, 

ingredients, or parts) to form a whole: COMBINE, UNITE 2a: to form or make up (as a composite

product) by combining different elements, ingredients, or parts (~a medicine) . . ." . (Webster's 

Third New International Dictionary, Unabridged Edition, 1976, page 466). Thus, compounding is 

different from repackaging. 

We reject the suggestion for two reasons. First, we return to the primary rule of

construction that legislative intent is determined from the words of the statute. Section 4046, 

subdivision (c)(1) provides that nothing in the law shall be construed to prohibit a pharmacist from

"furnishing to a prescriber a reasonable quantity of a compounded medication." The language

nowhere says that it is the pharmacist who is to do the compounding. A medication containing

multiple elements is a "compounded medication" whether compounded by the pharmacist, or

compounded by a drug company earlier and later repackaged by the pharmacy. The word 

"compounded" merely modifies the word "medication" and does not state by whom or when or

where the compounding is accomplished. 

Secondly, "[w]here the provisions of a statute are subject to two or more reasonable

interpretations, that which will harmonize rather than conflict with other provisions thereof should

be adopted. (Spreckles v. Graham, 194 Cal. 516, 527 [228 p.1040.]) . . ." (People v. Kuhn (1963)

216 Cal.App.2d 695, 698.) As will be recalled, section 4051 of the Pharmacy Law, supra, provides

now (and also provided in 1981, when § 4046 was enacted) that a prescriber may dispense drugs 

directly to his or her patients. Additionally, section 4227 of the Pharmacy Law provides now (and

also provided in 1981 in all material respects) that a pharmacist is not prohibited from furnishing

a dangerous drug to a "prescriber." Thus section 4227 provides in part: 

"(a) No person shall furnish any dangerous drug or device except upon the

prescription of a physician, dentist, podiatrist, or veterinarian. 

"(b) This section shall not apply to the furnishing of any dangerous drug or 

device by a manufacturer or wholesaler or pharmacy to each other or to a physician, 

dentist, podiatrist, or veterinarian, or to a laboratory under sales and purchase records

that correctly give the date, the names and addresses of the supplier and the buyer,

the drug or device and its quantity. . . ." (Emphasis added.) 

Accordingly, sections 4227 and 4051 when read together contemplate, and have contemplated since

before 1981, that a pharmacist may be supplying "any dangerous drug[s]" directly to a "prescriber",

whether compounded or repackaged. We found nothing in the legislative history to section 4046

to indicate an intent to limit these sections. (See also, generally, section 26693 of the Health and

Safety Code, a provision in the Sherman Food, Drug and Cosmetic Law, to the same effect both in

1981 and presently.) 

We therefore conclude on question two that "compounded medication" as used in

section 4046, subdivision (c)(1), does include medications compounded by a manufacturer which

are merely repackaged, and not reformulated or admixed by the pharmacist. 

5. 89-1101
 
 

3. "Prescriber Office Use" 

The third and final question presented is whether the words "prescriber office use"

as used in section 4046 subdivision (c)(1) is limited to the administration of such drugs in the

prescriber's office, or whether it also includes drugs which the prescriber dispenses to patients for

use outside the prescriber's office or clinic. We conclude that it includes drugs which the prescriber

dispenses to patients for use outside the prescriber's office or clinic. 

Initially, we note that the terminology "prescriber office use" means that the "use"

is that of the prescriber, not the patient. A prescriber "uses" a drug in his or her office position, that

is, "employs" it, "utilizes" it, "applies" it or "avails" himself or herself of it5 whether it is 

administered in the office to the patient or is dispensed to the patient for later ingestion or

administration. Had the Legislature intended that "prescriber office use" be restricted to "office 

administration," it could have easily said so by using such words of limitation. 

Furthermore, as already noted in our response to question two, (1) section 4051 of

the Pharmacy Law permitted in 1981 when section 4046 was enacted, and still permits, a prescriber

to "dispense" drugs to his or her patients; and (2) section 4227 of the Pharmacy Law contemplated

in 1981, and still contemplates, that a pharmacist can legally "furnish" any dangerous drug to a

prescriber. Neither of these provisions contained in 1981 nor now contain any limitation that such

drugs can be used only for administration in the prescriber's office. 

Accordingly, harmonizing section 4046, subdivision (c)(1), as added in 1981, with

both prior and current law, we believe that the Legislature did not intend to limit the term "office

use" to "office administration" in section 4046 while other sections of the Pharmacy Law (and even

the Sherman Food, Drug and Cosmetic Law, Health & Saf. Code, § 26693) neither provide for nor

contemplate such a limitation. 

We therefore conclude that "prescriber office use" as used in section 4046, 

subdivision (c)(1) includes furnishing drugs for prescribers which can be dispensed for

administration outside the prescriber's office or clinic. 

* * * * * 

5

See Webster's Third New International Dictionary, Unabridged Edition, 1976, page 2524 setting

forth the quoted words as synonyms for the verb "use." 

6. 89-1101