Can the Texas pharmacy board satisfy a duty to list narrow therapeutic index drugs with an empty list?

Plain-English summary

A house committee chair asked a pointed question: section 562.014 of the Occupations Code tells the Texas State Board of Pharmacy to "establish a list of narrow therapeutic index drugs," but the Board adopted a rule saying no drugs go on the list. Did the Board satisfy the legislative mandate by deciding that "no list is a list"?

Some background makes the question concrete. A "narrow therapeutic index drug" is one where very small changes in dose can cause toxic effects, so safe use requires careful dosing and monitoring. Texas law generally lets a pharmacist substitute a cheaper, generically equivalent drug unless the prescriber says "dispense as written." Section 562.014 carves out special treatment for narrow therapeutic index drugs on refills, requiring the same product from the same manufacturer unless the physician agrees otherwise. To trigger that protection, the Board, consulting the medical board, was to build the list.

The opinion concluded the Board's empty-list rule is valid. Section 562.014 imposes a mandatory duty to consult the Board of Medical Examiners and adopt a rule, which the Board did. But the statute does not dictate what the rule must say or require that any particular drug end up on the list. The legislature delegated to the Board, using its own and the medical board's expertise, the judgment of which drugs deserve special refill rules, and nothing barred the Board from concluding that none did. The opinion found the rule in harmony with the statute's purpose of protecting patients, because the Board relied on the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations and the physician's power to forbid substitution, and consistent with the broader goal of saving consumers money through generic substitution. Deferring to the agencies' expertise in a technical area, the opinion held the rule reasonable and a valid exercise of the Board's authority.

Currency note

This opinion was issued in 2001. Subsequent statutory amendments, court decisions, or later Attorney General 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.

What the opinion meant for those who asked

The Board of Pharmacy and Board of Medical Examiners (what the opinion held for them): The opinion held that the Board satisfied its section 562.014 duty by consulting the medical board and adopting a rule, and that determining no drugs belong on the narrow therapeutic index list was within the discretion the legislature delegated.

Pharmacists and patients (what the opinion held for them): The opinion treated the empty-list rule as meaning the ordinary substitution rules apply to refills, so a pharmacist may substitute only FDA-rated therapeutically equivalent products, and a prescriber may block substitution by marking "dispense as written."

Common questions

What is a narrow therapeutic index drug?
The opinion described it, drawing on an FDA regulation and the medical board, as a drug where very small dosage changes can cause toxic results, so safe use requires careful dosing and monitoring.

Did the pharmacy board ignore the law by leaving the list empty?
The opinion concluded it did not. The statute required the Board to consult and adopt a rule, but left the content to the Board's expert judgment, which could be that no drugs need special refill rules.

What protects patients if there is no special list?
The opinion pointed to the FDA's therapeutic-equivalence evaluations, which limit what pharmacists may substitute, and to the prescriber's ability to require the brand-name product by writing "dispense as written."

Background and statutory framework

The Texas Pharmacy Act (Occupations Code subtitle J) governs pharmacy practice, and chapter 562, subchapter A allows substitution of generically equivalent drugs, with the stated purpose of saving consumers money. See Tex. Occ. Code Ann. § 562.002 (Vernon 2001). Section 562.014 makes that substitution authority inapplicable to refills of narrow therapeutic index drugs and directs the Board, in consultation with the Board of Medical Examiners, to establish the list by rule. See id. § 562.014. The opinion read "shall" as imposing a duty under Government Code section 311.016(2), drew the working definition of a narrow therapeutic index drug from 21 C.F.R. § 320.33(c) (2000), and applied the standard that an agency rule is valid if authorized by and in harmony with the statute and reasonable, citing Railroad Comm'n v. Arco Oil & Gas Co., 876 S.W.2d 473 (Tex. App.-Austin 1994, writ denied), Edgewood Indep. Sch. Dist. v. Meno, 917 S.W.2d 717 (Tex. 1995), and State v. Public Util. Comm'n of Tex., 883 S.W.2d 190 (Tex. 1994).

Citations

Statutory and regulatory provisions:

• Tex. Occ. Code Ann. §§ 562.002, 562.014 (Vernon 2001)
• Tex. Gov't Code Ann. § 311.016(2) (Vernon 1998)
• 21 C.F.R. § 320.33(c) (2000)
• 22 Tex. Admin. Code §§ 309.3(d), 309.7(b)

Cases:

• Railroad Comm'n v. Arco Oil & Gas Co., 876 S.W.2d 473 (Tex. App.-Austin 1994, writ denied)
• Edgewood Indep. Sch. Dist. v. Meno, 917 S.W.2d 717 (Tex. 1995)
• Railroad Comm'n v. Lone Star Gas Co., 844 S.W.2d 679 (Tex. 1992)
• State v. Public Util. Comm'n of Tex., 883 S.W.2d 190 (Tex. 1994)

Source

• Landing page: https://www.texasattorneygeneral.gov/opinions/john-cornyn/jc-0341
• Original PDF: https://www.texasattorneygeneral.gov/sites/default/files/opinion-files/opinion/2001/jc0341.pdf

Original opinion text

Best-effort transcription from the official scanned PDF. Minor character-level errors from the source OCR have been corrected; the linked PDF is authoritative.

OFFICE OF THE ATTORNEY GENERAL - STATE OF TEXAS

JOHN CORNYN

February 12, 2001

The Honorable Toby Goodman
Chair, Committee on Juvenile Justice and Family Issues
Texas House of Representatives
P.O. Box 2910
Austin, Texas 78768-2910

Opinion No. JC-0341

Re: Whether a Texas State Board of Pharmacy rule specifying that no drugs shall be included on a list of narrow therapeutic index drugs is consistent with section 562.014 of the Texas Occupations Code, which requires the Board, by rule, to "establish a list of narrow therapeutic index drugs" (RQ-0289-JC)

Dear Representative Goodman:

Section 562.014 of the Texas Occupations Code provides that the general statutory provisions authorizing a pharmacist to substitute a generically equivalent drug for a prescribed drug do not apply to the refill of a prescription for a "narrow therapeutic index drug" and charges the Texas State Board of Pharmacy to "establish a list of narrow therapeutic index drugs." TEX. OCC. CODE ANN. § 562.014 (Vernon 2001). You ask whether a Texas State Board of Pharmacy rule specifying that no drugs shall be included on a list of narrow therapeutic index drugs, see 22 T.A.C. § 309.3(d)(2) (2000) (Tex. State Bd. of Pharm., Prescription Drug Orders), is consistent with section 562.014.(1) We conclude that the rule is consistent with section 562.014.

(Footnote 1: See Letter from Honorable Toby Goodman, Chair, Committee on Juvenile Justice and Family Issues, to Honorable John Cornyn, Texas Attorney General (Sept. 25, 2000) (on file with Opinion Committee) [hereinafter Request Letter].)

Title 3, subtitle J of the Texas Occupations Code, the Texas Pharmacy Act, TEX. OCC. CODE ANN. chs. 551-566 (Vernon 2001), regulates the practice of pharmacy in this state. The Texas State Board of Pharmacy (the "Board") is charged with administering and enforcing the Act, see id. chs. 552, 554, including regulating the delivery and distribution of prescription drugs, id. § 554.005(a)(1), and is authorized to adopt rules consistent with subtitle J, see id. § 554.051(a).

Chapter 562, subchapter A, governs the authority of a pharmacist to dispense prescribed drugs and to substitute generically equivalent products. Under subchapter A, a "generically equivalent" drug means a drug that is pharmaceutically (i.e., chemically) and therapeutically equivalent to the drug prescribed. See id. § 562.001(1); see also id. § 562.001(2) ("'Pharmaceutically equivalent' means drug products that have identical amounts of the same active chemical ingredients in the same dosage form and that meet the identical compendial or other applicable standards of strength, quality, and purity according to the United States Pharmacopoeia or another nationally recognized compendium."); id. § 562.001(3) ("'Therapeutically equivalent' means pharmaceutically equivalent drug products that, if administered in the same amounts, will provide the same therapeutic effect, identical in duration and intensity."). If the physician's signature on the prescription form does not indicate that the prescription must be dispensed as written, the pharmacist may select a generically equivalent drug. See id. § 562.008. A pharmacist who selects a generically equivalent drug must inform the patient of the substitution and of his or her right to refuse the substitution or must display a sign providing notice regarding substitutions. See id. § 562.009. Subchapter A specifically provides that it is the legislature's intent "to save consumers money by allowing the substitution of lower-priced generically equivalent drug products for certain brand name drug products." Id. § 562.002.

You ask about a rule adopted under section 562.014 of the Occupations Code, which limits the authority of a pharmacist to refill a prescription using a generically equivalent drug as a substitute for the drug originally prescribed, if that drug is a "narrow therapeutic index drug." Section 562.014 states as follows:

Except as provided by this section, drug selection as authorized by this subchapter does not apply to the refill of a prescription for a narrow therapeutic index drug. The board, in consultation with the Texas State Board of Medical Examiners, shall by rule establish a list of narrow therapeutic index drugs to which this subsection applies. A prescription for a narrow therapeutic index drug may be refilled only by using the same drug product by the same manufacturer that the pharmacist last dispensed under the prescription, unless otherwise agreed to by the prescribing physician. If a pharmacist does not have the same drug product by the same manufacturer in stock to refill the prescription, the pharmacist may dispense a drug product that is generically equivalent if the pharmacist, before dispensing the generically equivalent drug product, notifies:

(1) the patient, at the time the prescription is dispensed, that a substitution of the prescribed drug product has been made; and

(2) the prescribing physician of the drug product substitution by telephone, facsimile, or mail, at the earliest reasonable time, but not later than 72 hours after dispensing the prescription.

Id. § 562.014.

The term "narrow therapeutic index drug" is not defined in the Texas Pharmacy Act or elsewhere in the laws of this state. A Federal Food and Drug Administration regulation indicates that a "narrow therapeutic index drug" is one that

exhibit[s] a narrow therapeutic ratio, e.g., there is less than a 2-fold difference in median lethal dose . . . and median effective dose . . . values, or [has] less than a 2-fold difference in the minimum toxic concentrations and minimum effective concentrations in the blood, and safe and effective use of the drug product[] requires careful dosage titration and patient monitoring.

21 C.F.R. § 320.33(c) (2000). A brief from the Texas State Board of Medical Examiners explains that narrow therapeutic index drugs "are those medications where very small changes in the dosage level could cause toxic results in patients."(2)

(Footnote 2: Brief from Ms. Michele L. Shackelford, General Counsel, Texas State Board of Medical Examiners, to Ms. Susan D. Gusky, Chair, Opinion Committee 1-2 (Nov. 16, 2000) (on file with Opinion Committee).)

Pursuant to section 562.014, the Board has adopted the following rule as a subpart to section 309.3 of title 22 of the Texas Administrative Code:

(d) Refills.

(1) Original substitution instructions. Refills shall follow the original substitution instructions unless otherwise indicated by the practitioner or practitioner's agent.

(2) Narrow therapeutic index drugs.

(A) The board, in consultation with the Texas State Board of Medical Examiners, has determined that no drugs shall be included on a list of narrow therapeutic index drugs as defined in § 562.013 [sic], Occupations Code. The board has specified in § 309.7 of this title (relating to dispensing responsibilities) that pharmacist[s] shall use as a basis for determining generic equivalency, Approved Drug Products with Therapeutic Equivalence Evaluations and current supplements published by the Federal Food and Drug Administration, within the limitations stipulated in that publication.

(i) Pharmacists may only substitute products that are rated therapeutically equivalent in the Approved Drug Products with Therapeutic Equivalence Evaluations and current supplements.

(ii) Practitioners may prohibit substitution either by signing on the "Dispense as Written" line of a written prescription drug order or by clearly indicating on an oral prescription drug order that the brand name product must be dispensed.

(B) The board shall reconsider the contents of the list if the Federal Food and Drug Administration determines a new equivalence classification which indicates that certain drug products are equivalent but special notification to the patient and practitioner is required when substituting these products.

22 T.A.C. § 309.3(d) (2000) (emphasis added); see also id. § 309.7(b) ("Pharmacists shall utilize as a basis for the determination of generic equivalency as defined in the Act, . . . Approved Drug Products With Therapeutic Equivalence Evaluations and current supplements published by the Federal Food and Drug Administration, within the limitations stipulated in that publication.").

In short, the Board has determined that there are no "narrow therapeutic index drugs" for which special rules should apply with respect to the use of generic substitutions in refills. As a result, the same rules that apply to the use of generic substitutions in the filling of an original prescription and refills generally apply to refills for narrow therapeutic index drugs. As with original prescriptions and all other refills, see id. §§ 309.3-.4, .7, pharmacists may substitute only products that are rated therapeutically equivalent in the Federal Food and Drug Administration's Approved Drug Products with Therapeutic Equivalence Evaluations, see id. § 309.3(d)(2)(i), and practitioners may prohibit substitution either by signing on the "Dispense as Written" line of a written prescription drug order or by clearly indicating on an oral prescription drug order that the brand name product must be dispensed, see id. § 309.3(d)(2)(ii).

You ask whether the Board "has met the legislative mandate of § 562.014 of the Occupations Code to adopt a list of NTI drugs by its determination that no list is a list." Request Letter, supra note 1, at 2. We conclude that the Board's rule on narrow therapeutic index drugs satisfies the legislature's mandate and is therefore valid.

Your query suggests that the Board's determination that there are no therapeutic index drugs for which special refill rules should apply conflicts with section 562.014. In reviewing the rule, we are guided by the maxim that "an agency can adopt only such rules as are authorized by and consistent with its statutory authority." Railroad Comm'n v. Arco Oil & Gas Co., 876 S.W.2d 473, 481 (Tex. App.-Austin 1994, writ denied). The critical factor in determining whether an administrative agency has exceeded its rule-making authority is whether the rule's provisions are in harmony with the general objectives of the statute involved. Edgewood Indep. Sch. Dist. v. Meno, 917 S.W.2d 717, 750 (Tex. 1995); Railroad Comm'n v. Lone Star Gas Co., 844 S.W.2d 679, 685 (Tex. 1992). A court will uphold an agency rule if it is reasonable.

The Board's rule is not in conflict with section 562.014. Again, section 562.014 provides that, "[e]xcept as provided by this section, drug selection as authorized by this subchapter does not apply to the refill of a prescription for a narrow therapeutic index drug. The board, in consultation with the Texas State Board of Medical Examiners, shall by rule establish a list of narrow therapeutic index drugs to which this subsection applies." TEX. OCC. CODE ANN. § 562.014 (Vernon 2001). Section 562.014 imposes a mandatory duty on the Board to consult with the Board of Medical Examiners and to enact a rule, see TEX. GOV'T CODE ANN. § 311.016(2) (Vernon 1998) ("'Shall' imposes a duty."), which it has done. On its face, however, section 562.014 does not dictate the substance of the rule or necessarily preclude the Board from determining that there are no narrow therapeutic index drugs to which special refill rules should apply. Rather, the legislature has delegated the authority to develop a list of narrow therapeutic index drugs to the Board, and specified that it do so in consultation with the Board of Medical Examiners. In enacting this provision, the legislature intended the Board, using its expertise and the expertise of the Board of Medical Examiners, to exercise judgment and discretion in selecting drugs the refill of which should be subject to special treatment. We do not believe it is inconsistent with this delegation of authority for the Board to determine that there are no narrow therapeutic index drugs to which special refill rules should apply.

Furthermore, we believe that the rule is in harmony with the general objectives of section 562.014. The purpose of section 562.014 appears to be to protect patients from adverse health consequences from the substitution of generic drugs. It is clear from the face of the rule that the Board has determined that use of the Federal Food and Drug Administration's Approved Drug Products with Therapeutic Equivalence Evaluations and physicians' option to prohibit the use of generic substitutions adequately protect patients. See 22 T.A.C. § 309.3(d)(2)(i), (ii) (2000) (Tex. State Bd. of Pharm., Prescription Drug Orders). In addition, we note that the purpose of subchapter A is to encourage the use of generic drugs "to save consumers money." TEX. OCC. CODE ANN. § 562.002 (Vernon 2001). The Board rule is in harmony with the general objectives of section 562.014 and the overall purpose of subchapter A.

As to whether the rule is reasonable, we defer, as we believe a court would, to the Board and the State Board of Medical Examiners' expertise in making judgments in this highly technical area. See generally State v. Public Util. Comm'n of Tex., 883 S.W.2d 190, 197 (Tex. 1994) ("When an administrative agency is created to centralize expertise in a certain regulatory area, it is to be given a large degree of latitude in the methods it uses to accomplish its regulatory function.").

In sum, the Board's rule is consistent with section 562.014 and is in harmony with both the general objectives of that statute and of subchapter A. We believe that a court would determine that the rule is reasonable. We conclude that the rule is a valid exercise of the Board's authority.

SUMMARY

A Texas State Board of Pharmacy rule, 22 T.A.C. § 309.3(d)(2) (2000) (Tex. State Bd. of Pharm., Prescription Drug Orders), which specifies that no drugs shall be included on a list of narrow therapeutic index drugs to which special refill rules should apply, is consistent with section 562.014 of the Texas Pharmacy Act, TEX. OCC. CODE ANN. § 562.014 (Vernon 2001).

JOHN CORNYN
Attorney General of Texas

ANDY TAYLOR
First Assistant Attorney General

CLARK KENT ERVIN
Deputy Attorney General - General Counsel

SUSAN D. GUSKY
Chair, Opinion Committee

Mary R. Crouter
Assistant Attorney General - Opinion Committee