Cal. Code Regs. Tit. 8, § 9792.27.1 - Medical Treatment Utilization Schedule (Mtus) Drug Formulary - Definitions

For purposes of sections 9792.27.1 through 9792.27.23, the following definitions shall apply:

(a) "Administer" means the direct application of a drug or device to the body of the patient by injection, inhalation, ingestion, or other means.

(b) "Authorization through prospective review" means authorization for proposed treatment obtained through the utilization review process set forth in section 9792.6.1 et seq.

(c) "Brand name drug" means a drug that is produced or distributed under an FDA original New Drug Application (NDA) or Biologic License Application (BLA) approved by the FDA. It also includes a drug product marketed by any cross-licensed producers or distributors operating under the same NDA or BLA.

(d) "Combination drug" means a fixed dose combination of two or more active drug ingredients into a single dosage form that is FDA-approved for marketing.

(e) "Compounded drug" means any drug subject to:

(1) Article 4.5 (commencing with section 1735) or article 7 (commencing with section 1751) of division 17 of title 16 of the California Code of Regulations, or

(2) Other regulation adopted by the State Board of Pharmacy to govern the practice of compounding, or

(3) Federal law governing compounding, including title 21, United State Code, sections 353 a, 353a-1, 353b.

(f) "Dispense" means:

1) the furnishing of a drug upon a prescription from a physician or other health care provider acting within the scope of his or her practice, or

2) the furnishing of drugs directly to a patient by a physician acting within the scope of his or her practice.

(g) "Executive Medical Director" means the medical director of the Division of Workers' Compensation.

(h) "Exempt drug" means a drug on the MTUS Drug List which is designated as being a drug that does not require authorization through prospective review prior to dispensing the drug, provided that the drug is prescribed in accordance with the MTUS Treatment Guidelines. The Exempt status of a drug is designated in the column with the heading labeled "Exempt / "Exempt / Non-Exempt."

(i) "Expedited review" means the expedited utilization review conducted prior to the delivery of the requested medical services, in accordance with Labor Code section 4610 and title 8, California Code of Regulations section 9792.6.1 et seq.

(j) "FDA" means the United States Food and Drug Administration within the United States Department of Health & Human Services.

(k) "FDA-approved drug" means a prescription or nonprescription drug that has been approved by the FDA under the federal Food, Drug, and Cosmetic Act, title 21, United States Code, section 301 et seq.

(l) "Generic drug" means a drug that is produced or distributed under an FDA Abbreviated New Drug Application (ANDA) approved by the FDA. A generic drug may be substituted for a therapeutic equivalent brand name drug pursuant to applicable state and federal laws and regulations.

(m) "MTUS Drug Formulary" means the MTUS Drug List set forth in section 9792.27.15 and the formulary rules set forth in sections 9792.27.1 through 9792.27.23.

(n) "MTUS Drug List" means the drug list and related information in section 9792.27.15, which sets forth the Exempt or Non-Exempt status of drugs listed by active drug ingredient(s).

(o) Non-Exempt drug" means a drug on the MTUS Drug List which is designated as requiring authorization through prospective review prior to dispensing the drug. The Non-Exempt Drug status of a drug is designated in the column labeled "Exempt / Non-Exempt."

(p) "Nonprescription drug" or "over-the-counter drug" (OTC drug) means a drug which may be sold without a prescription and which is labeled for use by the consumer without the supervision of a health care professional.

(q) "Off-label use" means use of a drug for a condition, or in a dosage or method of administration, not listed in the drug's FDA-approved labeling for approved use.

(r) "OTC Monograph" means a monograph established by the FDA setting forth acceptable ingredients, doses, formulations, and labeling for a class of OTC drugs.

(s) "Perioperative Fill" means the policy set forth in section 9792.27.13 allowing dispensing of identified Non-Exempt drugs without prospective review where the drug is prescribed within the perioperative period and meets specified criteria.

(t) "P&T Committee" means the Pharmacy and Therapeutics Committee established by the Administrative Director pursuant to Labor Code section 5307.29 to review and consult with the administrative director on available evidence of the relative safety, efficacy, and effectiveness of drugs within a class of drugs in the updating of the evidence-based drug formulary.

(u) "Physician": Notwithstanding the definition in Labor Code section 3209.3, for purposes of the MTUS Drug Formulary, "Physician" means a medical doctor, doctor of osteopathy, or other health care provider whose scope of practice includes the prescription of drugs. However, for purposes of membership on the P&T Committee, "physician" means a medical doctor or doctor of osteopathy licensed pursuant to the California Business and Professions Code.

(v) "Prescription drug" means any drug whose labeling states "Caution: Federal law prohibits dispensing without prescription," "Rx only," or words of similar import.

(w) "Prospective review" means the utilization review conducted prior to the delivery of the requested medical services, in accordance with Labor Code section 4610 and title 8, California Code of Regulations section 9792.6.1 et seq.

(x) "Special Fill" means the policy set forth in section 9792.27.12 allowing dispensing of identified Non-Exempt drugs without prospective review where the drug is prescribed or dispensed in accordance with the criteria set forth in subdivision (b) of section 9792.27.12.

(y) A "therapeutic equivalent" is a drug designated by the FDA as equivalent to a Reference Listed Drug if the two drugs are pharmaceutical equivalents (contain the same active ingredient(s), dosage form, route of administration and strength), and are bioequivalent (comparable availability and rate of absorption of the active ingredient(s).) Drugs that the FDA considers to be therapeutically equivalent products are assigned a Therapeutic Equivalence Evaluation Code beginning with the letter "A" in the FDA publication "Orange Book: Approved Products with Therapeutic Equivalence Evaluations" which is available on the FDA website and accessible via a link provided on the department's website.

(z) "Unlisted drug" means a drug that does not appear on the MTUS Drug List and which is one of the following: an FDA-approved or a nonprescription drug that is marketed pursuant to an FDA OTC Monograph. An "unlisted drug" does not include a compounded drug but does include a combination drug.

Notes

Cal. Code Regs. Tit. 8, § 9792.27.1

1. New section filed 12-7-2017; operative 1-1-2018 pursuant to Government Code section 11343.4(b)(3) (Register 2017, No. 49).

Note: Authority cited: Sections 133, 4603.5, 5307.3 and 5307.27, Labor Code. Reference: Sections 4600, 4604.5, 5307.27 and 5307.29, Labor Code.

1. New section filed 12-7-2017; operative 1/1/2018 pursuant to Government Code section 11343.4(b)(3) (Register 2017, No. 49).