Cal. Code Regs. tit. 17 § 10405

Current through Register 2024 Notice Reg. No. 25, June 21, 2024

Section 10405 - Directions for Use -Exemptions Thereto

(a) Adequate Directions for Use. "Adequate directions for use" means directions under which a layperson can use drug or device safely and for the purposes for which it is intended. Directions for use may be inadequate because (among other reasons) of omission, in whole or in part, or incorrect specification of:

(1) Statements of all conditions, purposes, or uses for which such drug or device is intended, including conditions, purposes, or uses for which it is prescribed, recommended, or suggested in its oral, written, printed, or graphic advertising, and conditions, purposes, or uses for which the drug or device is commonly used; except that such statements shall not refer to conditions, uses, or purposes for which the drug or device can be safely used only under the supervision of a practitioner licensed by law and for which it is advertised solely to such practitioner.

(2) Quantity of dose (including usual quantities for each of the uses for which it is intended and usual quantities for persons of different ages and different physical conditions).

(3) Frequency of administration or application.

(4) Duration of administration or application.

(5) Time of administration or application (in relation to time of meals, time of onset of symptoms, or other time factors).

(6) Route or method of administration or application.

(7) Preparation for use (shaking, dilution, adjustment of temperature, or other manipulation or process).

(8) Methods of application or use.

(b) Exemptions From Directions for Use. Drugs and devices subject to Section 26638 of the code, shall be exempt from the requirements under the following conditions:

(1) Exemptions for Drugs and Devices Shipped Directly to Licensed Practitioners, Hospitals, Clinics, or Public Health Agencies for Professional Use. Except as provided in subparagraph (3) of paragraph (b) of this section, a drug or device shipped directly to or in the possession of a practitioner licensed by law to administer the drug or to use or direct the use of the device, or shipped directly to or in the possession of a hospital, clinic, or public health agency, for use in the course of the professional practice of such a licensed practitioner, shall be exempt from Section 26638 of the code if its meets the conditions of Section 10410 (b) and (c), Section 10415 (a) (2) and (3) or Section 10415 (b) (2) and (3) of these regulations.

(2) Retail Exemption for Veterinary Drugs and Prescription Devices. A drug or device subject to Section 10410 or Section 10415 (b) of these regulations shall be exempt at the time of delivery to the ultimate purchaser or user from Section 26638 of the code if it is delivered by a licensed practitioner in the course of the practitioner's professional practice or upon a prescription or other order lawfully issued in the course of his professional practice, with labeling bearing the name and address of such licensed practitioner and the directions for use and cautionary statements, if any, contained in such order.

(3) Exemption for New Drugs or Devices. A new drug or device shall be exempt from Section 26638 of the code:

(A) To the extent to which such exemption is claimed in an effective application with respect to such drug or device under Section 26670 of the code; or

(B) If no application under Section 26670 of the code is effective with respect to such drug but it complies with Section 26679 of the code and Section 10440 of the regulations thereunder. No exemptions shall apply to any other drug or device which would be a new drug or device if its labeling bore representation for its intended uses.

(4) Exemption for Drugs or Devices When Directions Are Commonly Known. A drug or device shall be exempt from Section 26638 of the code insofar as adequate directions for common uses thereof are known to the ordinary individual.

(5) Exemptions for Inactive Ingredients. A harmless drug that is ordinarily used as an inactive ingredient, such as a coloring, emulsifier, excipient, flavoring, lubricant, preservative, or solvent, in the preparation of other drugs shall be exempt from Section 26638 of the code. This exemption shall not apply to any substance intended for a use which results in the preparation of a new drug, unless an effective new drug application provides for such use.

(6) Exemption for Diagnostic Reagents. A product intended for use in the diagnosis of disease and which is an in vitro diagnostic product shall be exempt from Section 26638 of the code if it meets the requirements of Section 809.10 of Title 21 of the Code of Federal Regulations.

(7) Exemption for Prescription Chemicals and Other Prescription Components. For use by registered pharmacists in compounding prescriptions or for dispensing in dosage unit form upon prescriptions shall be exempt from Section 26638 of the code if all the following conditions are met:

(A) The drug is an official liquid acid or official liquid alkali, or is not a liquid solution, emulsion, suspension, tablet, capsule, or other dosage unit form; and

(B) The label of the drug bears:

1. The statement "For prescription compounding"; and

2. If in substantially all dosage forms in which it may be dispensed it is subject to Section 26662 of the code, the statement "Caution: Federal law prohibits dispensing without prescription," or "Caution: Not to be dispensed without a prescription"; or,

3. If it is not subject to Section 26662 of the code and is by custom among retail pharmacists sold in or from the intrastate package for use by consumers, "Adequate directions for use" in the conditions for which it is so sold. Provided, however, that the information referred to in subdivision 3 of this subparagraph may be contained in the labeling on or within the package from which it is to be dispensed.

(C) This exemption shall not apply to any substance intended for use in compounding which results in a new drug, unless an effective new drug application covers such use of the drug in compounding prescriptions.

(8) Exemption for Processing, Repacking, or Manufacture. A drug in a bulk package (except tablets, capsules, or other dosage unit forms) or a device intended for processing, repacking, or use in the manufacture of another drug or device shall be exempt from Section 26638 of the code if its label bears the statement "Caution: For manufacturing, processing, or repacking"; and, if in substantially all dosage forms in which it may be dispensed it is subject to Section 26662, the statement "Caution: Federal law prohibits dispensing without prescription," or "Caution: Not to be dispensed without a prescription." This exemption and the exemption under paragraph (7) of this section may be claimed for the same article. But the exemption shall not apply to a substance, material, or device intended for use in manufacture, processing, or repacking which causes the finished article to be a new drug, unless:

(A) An effective new drug application held by the person preparing the dosage form or drug for dispensing covers the production and delivery to that person of such substance; or

(B) If no application is effective with respect to such new drug, the label statement "Caution: For manufacturing, processing, or repacking" is immediately supplemented by the words "in the preparation of a new drug limited by state law to investigational use," and the delivery is made for use only in the manufacture of such new drug limited to investigational use as provided in Section 10560 of these regulations.

(9) Exemption for Drugs and Devices for Use in Teaching, Research, and Analysis. A drug or device subject to Sections 10410 and 10415 (a) and (b) of these regulations shall be exempt from Section 26638 of the code if shipped or sold to, or in the possession of, persons regularly and lawfully engaged in instruction in pharmacy, chemistry, or medicine not involving clinical use, or engaged in law enforcement, or research not involving clinical use, or in clinical analysis, or physical testing, and is to be used only for such instruction, law enforcement, research, analysis, or testing.

(10) Expiration of Exemptions.

(A) If a shipment or delivery or any part thereof, of a drug or device which is exempt under the regulations in this section is made to a person in whose possession the article is not exempt or is made for any purpose other than those specified, such exemption shall expire, with respect to such shipment or delivery or part thereof, at the beginning of that shipment or delivery. The causing of an exemption to expire shall be considered an act which results in such drug or device being misbranded unless it is disposed of under circumstances in which it ceases to be a drug or device.

(B) The exemptions conferred by paragraphs (5), (6), (7), (8), and (9) of this section shall continue until the drugs or devices are used, for the purposes for which they are exempted, or until they are relabeled to comply with Section 26638 of the code. If, however, the drug is converted, compounded, or manufactured into a dosage form limited to prescription dispensing, no exemption shall thereafter apply to the article unless the dosage form is labeled as required by Section 26662 of the code and Sections 10410 and 10415 (a) and (b) of these regulations.

(c) Intended Uses. The words "intended uses" or words of similar import in paragraphs (a) and (b) of this section refer to the objective intent of the persons legally responsible for the labeling of drugs and devices. The intent is determined by such persons' expressions or may be shown by the circumstances surrounding the distribution of the article. This objective intent may, for example, be shown by labeling claims, advertising matter, or oral or written statements by such persons or their representatives. It may be shown by the circumstances that the article is, with the knowledge of such persons or their representative, offered and used for a purpose for which it is neither labeled nor advertised. The intended uses of an article may change after it has been introduced into intrastate commerce by its manufacturer. If, for example, a packer, distributor, or seller intends an article for different uses than those intended by the person from whom the packer distributor, or seller received the drug, such packer, distributor, or seller is required to supply adequate labeling in accordance with the new intended uses. But if a manufacturer knows, or has knowledge of facts that would give one notice, that a drug or device introduced into intrastate commerce by said manufacturer is to be used for conditions, purposes or uses other than the ones for which it is offered, the manufacturer is required to provide adequate labeling for such a drug which accords with such other uses to which the article is to be put.

Cal. Code Regs. Tit. 17, § 10405

1. Amendment filed 8-17-56; effective thirtieth day thereafter (Register 56, No. 16).
2. Amendment filed 6-27-60; effective 30th day thereafter (Register 60, No. 15).
3. Amendment filed 12-17-85; effective thirtieth day thereafter (Register 85, No. 51).

Note: Authority cited: Sections 208 and 26202, Health and Safety Code. Reference: Sections 26638 and 26662, Health and Safety Code.