delivered the opinion of the Court.
After suffering a severe adverse reaction to a compounded drug administered by her physician, Stacey Miller sued the compounding pharmacy and several of its licensed-pharmacist employees. We are asked whether Miller’s claims against these defendants are health care liability claims subject to the requirements of the Texas Medical Liability Act. If they are, then Miller’s failure to serve them with an expert report pursuant to the Act requires dismissal of her suit. Holding that Miller’s causes of action are not health care liability claims, the trial court denied the defendants’ motion to dismiss, and the court of appeals affirmed. We disagree and reverse the court of appeals’ judgment.
I. Background
In 2011, Dr. Ricardo Tan treated Miller for symptoms related to her previously diagnosed Hepatitis C. He prescribed and administered weekly intravenous injections of 200 mg/ml lipoic acid, an antioxidant supplement. According to Miller’s petition, she underwent nine weeks of treatment without incident. However, she suffered a severe adverse reaction while receiving a lipoic-acid treatment on December 5, 2011. She alleged that, as a result, she was hospitalized for several weeks, received multiple blood transfusions, and is now permanently blind in both eyes. Randol Mill Pharmacy, a licensed compounding pharmacy in Arlington, compounded the particular vial of li-poic acid to which Miller reacted. It was prepared as part of an order Dr. Tan had placed with Randol Mill for twenty-three 30-ml vials of lipoic acid for office use, without reference to any particular patient.
Taking the position that Miller had asserted health care liability claims governed by the Texas Medical Liability Act, see Tex. Civ. Prac. & Rem. Code §§ 74.001-.507, the pharmacist defendants moved to dismiss Miller’s claims with prejudice for failure to serve an expert report within 120 days of her filing suit, see id. § 74.351. The trial court denied the motion, and a divided court of appeals affirmed,
II. Analysis
This case presents issues of statutory interpretation, which we review de novo. Zanchi v. Lane,
A. Relevant Provisions of the Texas Medical Liability Act
The Texas Medical Liability Act provides a comprehensive statutory framework governing health care liability claims. Id. at 232. It is intended to strike “a careful balance between eradicating frivolous [health care liability] claims and preserving meritorious ones.” Leland v. Brandal,
The Act defines “health care liability claim” as
a cause of action against a health care provider or physician for treatment, lack of treatment, or other claimed departure from accepted standards of medical care, or health care, or safety or professional or administrative services directly related to health care, which proximately results in injury to or death of a claimant, whether the claimant’s claim or cause of action sounds in tort or contract.
Id. § 74.001(13). Thus, only claims brought against physicians or health care providers may qualify as health care liability claims. A “health care provider” is “any person, partnership, professional association, corporation, facility, or institution duly licensed, certified, registered, or chartered by the State of Texas to provide health care, including ... a pharmacist.” Id. § 74.001(12)(A)(iv). Employees and independent contractors of health care providers who are acting within the scope of the employment or contractual relationship also qualify as health care providers. Id. § 74.001(12)(B)(ii). Finally, the Act defines “pharmacist” as
one licensed under Chapter 551, Occupations Code, who, for the purposes of this chapter, performs those activities limited to the dispensing of prescription medicines which result in health care liability claims and does not include any other cause of action that may exist at common law against them, including but not limited to causes of action for the sale of mishandled or defective products.
Id. § 74.001(22).
B. General Definition of Health Care Provider vs. Specific Definition of Pharmacist
As an initial matter, we address the pharmacist defendants’ argument that they qualify as health care providers under the term’s general definition irrespective of the more specific definition of pharma
This argument has appeal when the Act’s definitions are viewed in isolation, but our well-settled rules of statutory interpretation require us to “examine the entire act to glean its meaning” and to “presume that ‘the entire statute is intended to be effective.’ ” Meritor Auto., Inc. v. Ruan Leasing Co.,
More specifically, Randol Mill’s interpretation renders the definition of pharmacist wholly superfluous because defendants who are licensed under chapter 551 of the Occupations Code — the first requirement to meet the pharmacist definition — automatically fall within the broader definition of health care provider. But the remainder of the pharmacist definition expressly narrows the circumstances in which such defendants may be considered health care providers, principally by limiting the qualifying activities to “the dispensing of prescription medicines that result in health care liability claims.” Tex. Civ. Prao. & Rem. Code § 74.001(22). And the referenced chapter 551 of the Occupations Code, which is the first chapter of the Texas Pharmacy Act, encompasses the licensing of both pharmacies like Randol Mill and individual pharmacists. See Tex. OCC. Code §§ 551.002(c), .003(3)-(7), (28). Accordingly, both Randol Mill and the individual defendants in this case qualify as health care providers under the Medical Liability Act only if they meet the Act’s definition of pharmacist.
C. The Defendants Are Pharmacists
This is our first opportunity to examine the Medical Liability Act’s application to claims against pharmacists in general and compounding pharmacists in particular. In the typical case against a pharmacy involving claims of misfilled prescriptions, the courts of appeals are generally in agreement — and often the parties do not dispute — that the Act applies and an expert report is required. See, e.g., Walgreen Co. v. Hieger,
1. Pharmacy Compounding
Generally, drug compounding is the process by which a pharmacist mixes or alters drugs to create a medication that is tailored to the needs of an individual patient and that is not otherwise commercially
Texas is one of “[m]any States” that “specifically regulate compounding practices as part of their regulation of pharmacies.” Thompson,
the preparation, mixing, assembling, packaging, or labeling of a drug or device:
(A) as the result of a practitioner’s prescription drug order based on the practitioner-patient-pharmacist relationship in the course of professional practice;
(B) for administration to a patient by a practitioner as the result of a practitioner’s initiative based on the practitioner-patient-pharmacist relationship in the course of professional practice;
(C) in anticipation of a prescription drug order based on a routine, regularly observed prescribing pattern; or
(D) for or as an incident to research, teaching, or chemical analysis and not for selling or dispensing, except as allowed under Section 562.154 or Chapter 563 [of the Occupations Code].,
Tex. Occ. Code § 551.003(9); 22 Tex. Admin. Code §§ 291.131(b)(3), .133(b)(14). Pertinent to this case, the Pharmacy Act permits a pharmacy to “dispense and deliver a reasonable quantity
2. Randol Mill Was Dispensing Prescription Medicines
As noted above, licensed pharmacists and pharmacies are health care providers for purposes of the Medical Liability Act with respect to “those activities limited to the dispensing of prescription medicines which result in health care liability claims.” Tex. Civ. Prac. & Rem. Code § 74.001(22). They are not considered health care providers with respect to “any other cause of action that may exist at common law against them, including but not limited to causes of action for the sale of mishandled or defective products.” Id. The parties dispute whether the pharmacist defendants’ act of compounding the injectable lipoic acid that Dr. Tan administered to Miller constituted “the dispensing of prescription medicines.” We hold that it did.
The Medical Liability Act does hot define the word “dispense,” but the Pharmacy Act does: “ ‘Dispense’ means to prepare, package, compound, or label, in the course of professional practice, a prescription drug or device for delivery to an ultimate user or the user’s agent under a practitioner’s lawful order.” Tex. Oco. Code § 551.003(16). An “ultimate user” is “a person who obtains or possesses a prescription drug ,... for the person’s own use.” Id. § 551.003(43). The court of appeals recognized that a doctor or nurse administering the drug to the ultimate user, such as Dr. Tan, may qualify as the “user’s agent.”
As noted above, a pharmacist may “dispense and deliver a reasonable quantity of a compounded drug to a practitioner for office use.” Tex. Occ. Code § 562.152. Because a “reasonable quantity” is an amount that the practitioner “anticipates may be used” before the drug’s expiration date, the Pharmacy Act specifically contemplates that a pharmacist may “dispense” a compounded drug to a practitioner without knowing the specific identity of the ultimate user. Further, and importantly, when a drug is dispensed for office use, it means that the practitioner will be administering the drug to the patient. Id. § 562.151(1) (defining “office use”). The limitations on this practice are thus designed to ensure that the compounded drug is administered in a health care set
Miller alternatively argues that the pharmacy defendants do not fall within the Medical Liability Act’s definition of pharmacist because the compounded lipoic acid that Randol Mill delivered to Dr. Tan is not a prescription medicine. Tex. Civ. Prac. & Rem. Code § 74.001(22) (defining “pharmacist” to extend to “activities limited to the dispensing of prescription medicines”). As with the term “dispense,” the Medical Liability Act does not define “prescription medicines.” Neither does the Pharmacy Act, although that Act does define the term “prescription drug” as
(A) a substance for which federal or state law requires a prescription before the substance may be legally dispensed to the public;
(B) a drug or device that under federal law is required, before being dispensed or delivered, to be labeled with the statement:
(i) “Caution: federal law prohibits dispensing without prescription” or “Rx only” or another legend that complies with federal law; or
(ii) “Caution: federal law restricts this drug to use by or on the order of a licensed veterinarian”; or
(C)a drug or device that is required by federal or state statute or regulation to be dispensed on prescription or that is restricted to use by a practitioner only.
Tex. Occ. Code § 551.003(36). The ordinary meaning of prescription drug — “a drug that can be bought only as prescribed by a physician” — is similar to subsection (A) of the statutory definition. WebsteR’s Third New Int’l Dictionary 1792 (2002). Miller argues that no evidence shows that lipoic acid, in any form, qualifies as a prescription drug.
We first note that the Legislature’s choice of the term “medicine” rather than “drug” in the Medical' Liability Act likely will not affect the statute’s application in most circumstances. The dictionary definition of medicine is “a substance or preparation used in treating disease.” Id. at 1402. The Pharmacy Act’s definition of drug is broader, but includes “a substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.” Tex. OCC. Code § 551.003(18)(B). The parties do not argue that the injecta-ble lipoic acid at issue meets the definition of drug but not medicine, or vice versa. They dispute only whether a prescription is required for patient use.
To that end, the Pharmacy Act’s provisions governing compounding confirm that compounded drugs may not be given to a patient absent a doctor’s order. Unless incident to research, “compounding” occurs only (1) as the result of a prescription drug order, (2) in anticipation of a prescription drug order, or (3) “for administration to a patient by a practitioner as the result of a practitioner’s initiative.” Id. § 551.003(9). The first two categories ex
The requirement that a compounded drug be prescribed by a practitioner is consistent with the purpose served by the practice, which is to supply a drug in a form or dose that is not commercially available, but that the practitioner has concluded will best meet her patient’s needs.
3. Miller’s Claims Are Health Care Liability Claims
Finally, we determine whether the pharmacist defendants’ complained-of “activities ... resulted] in health care liability claims.” Id. We thus consider whether Miller has asserted causes of action “for treatment, lack of treatment, or other claimed departure from accepted standards of medical care, or health care, or safety or professional or administrative services directly related to health care, which proximately resulted] in injury to [MiUer].”
' In this case, Dr. Tan ordered compounded injectable lipoic acid for office administration to his patients, and the pharmacist defendants compounded the lipoic acid for that purpose. Dr. Tan administered the lipoic acid to Miller in the course of her treatment for Hepatitis C symptoms. Miller asserts that the pharmacist defendants’ negligence in compounding the drug and their inclusion of inadequate warnings and instructions regarding its use proximately caused her injuries. Whether stated as negligence or breach of warranty, these claims rather clearly allege that the pharmacist defendants departed from accepted standards of health care. See Marks v. St. Luke’s Episcopal Hosp.,
Miller asserts, however, that her claims are in the nature of product-liability claims and are excluded from the Medical Liability Act’s umbrella because, while the Act defines pharmacist to include “activities limited to the dispensing of prescription medicines which result in health care liability claims,” it “does not include any other cause of action that may exist at common law against [pharmacists], including but not limited to causes of action for the sale of mishandled or defective products.” Tex. Civ. Prac. & Rem. Code § 74.001(22). We cannot construe this exclusion as broadly as Miller suggests because, so construed, it would swallow the Act’s application to causes of action involving negligent compounding that otherwise qualify as health care liability claims.
We note that subsection 74.001(22) references the “sale” of defective products. Presumably this would extend to a pharmacy’s liability as a “retailer or other member of the marketing chain” of a defective product, as well as its right to indemnity from the manufacturer where the pharmacy “is merely a conduit for the defective product.” Duncan v. Cessna Aircraft Co.,
At their core, Miller’s claims call into question Randol Mill’s compliance with professional standards of care applicable to pharmacies that perform compounding services, which implicates a host of complex regulations governing compounding practices in Texas. See generally 22 Tex. Admin. Code §§ 291.131, .133. Determining whether the pharmacist defendants complied with these standards will inevitably require the testimony of experts in the field. See Garland Cmty. Hosp. v. Rose,
III. Conclusion
In sum, we hold that the Medical Liability Act applies to Miller’s claims against the pharmacist defendants. Under the applicable version of that Act, she was required to serve the defendants with an expert report within 120 days of filing suit. Because it is undisputed that she failed to do so, her claims must be dismissed. Accordingly, we reverse the court of appeals’ judgment and remand the case to the trial court for further proceedings consistent with this opinion.
Notes
. The individual defendants are Gary G. Daley, John Wayne Bailey, James Robert For-sythe, Kevin Lynn Heide, Julie Knowlton Lubbert, and Cara Morrell. Defendant KVG Enterprises, Inc. is the corporation doing business as Randol Mill.
. Although a court of appeals' judgment is generally final in an interlocutory appeal, we have jurisdiction when that court’s justices “disagree on a question of law material to the decision.” Tex. Gov’t Code § 22.225(b)(3), (c).
.The version of the statute applicable to this case required the reports to be served "not later than the 120th day after the date the original petition was filed.” Act of May 18, 2005, 79th Leg., R.S., ch. 635, § 1, sec.
. Miller’s live pleading alleges that notice was sent to the pharmacist defendants pursuant to section 74.051 of the Act, which requires a person asserting a health care liability claim to send written notice "to each physician or health care provider against whom such claim is being made at least 60 days before” suit is filed. Citing our opinion in HoriZon/CMS Healthcare Corp. v. Auld,
. A "reasonable quantity” of a compounded drug "does not exceed the amount a practitioner anticipates may be used in the practitioner’s office before the expiration date,” "is reasonable considering the intended use of the compounded drug and the nature of the practitioner’s practice,” and does not exceed "an amount the pharmacy is capable of compounding in compliance with [applicable] pharmaceutical standards for identity, strength, quality, and purity” of the drug. Tex. Occ. Code § 562.151(3).
. "Office use” is defined in pertinent part as the "administration of a compounded drug to a patient by a practitioner in the practitioner's office or by the practitioner in a health care facility or treatment setting.” Id. § 562.151(1); 22 Tex. Admin. Code § 291.133(b)(32).
. The U.S. Pharmacopoeia is "an independent compendium of drug standards.” Med. Ctr. Pharmacy v. Mukasey,
. "Prescription drug order” is defined in pertinent part as "an order from a practitioner or a practitioner’s designated agent to a pharmacist for a drug or device to be dispensed.” Tex. Occ. Code § 551.003(37)(A).
. The regulations do allow compounding of commercially available products at a practitioner's request under narrow circumstances when the "product is not reasonably available from normal distribution channels in a timely manner to meet the patient’s needs.” 22 Tex Admin. ■ Code §§ 291.131(d)(1)(C), .133(d)(1)(C).
.The statutory language is somewhat circular because one of the elementó of a health care liability claim is that it is asserted against a health care provider, and one of the requirements for a defendant to qualify as a pharmacist — and thus as a health care provider — is that the conduct for which it is sued results in a health care liability claim. Tex. Civ. Prac. & Rem. Code § 74.001(13), (22).