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s 10377.4. Requirements for the Storage and Handling of Human Prescription Drugs.
(a) All facilities at which human prescription manufacturers manufacture, store, warehouse, handle, offer, market, display, or otherwise hold human prescription drugs shall be secure from unauthorized entry and shall have adequate security conditions, as follows:
(1) Access from outside the premises shall be kept to a minimum and be well-controlled;
(2) The outside perimeter of the premises shall be well-lighted; and
(3) Entry into areas where human prescription drugs are held shall be limited to authorized personnel.
(b) All such facilities shall be equipped with an alarm system to detect entry after hours.
(c) All such facilities shall be equipped with an alarm system that will provide suitable protection against theft and diversion. When appropriate, the security system shall provide protection against theft or diversion that is facilitated or hidden by tampering with computers or electronic records.
(d) Each outgoing shipment of human prescription drugs shall be carefully inspected for identity of the human prescription drugs and to ensure that there is no delivery of human prescription drugs that have been damaged in storage or held under improper conditions. Records of nonconforming drugs and their disposition shall be established and maintained, and shall include the name and label potency of the drug product, dosage form, lot number, quantity, reason for nonconformance, name of the inspector, date of inspection, and disposition.
(e) Human prescription drugs manufactured by the licensee, which are outdated, damaged, deteriorated, misbranded, or adulterated, shall be quarantined and physically separated from other prescription drugs until they are destroyed or brought into compliance with all applicable laws by reprocessing or relabeling. Records of drugs quarantined shall be established and maintained, and shall include the name and label potency of the quarantined drug product, dosage form, lot number, reason for the quarantine, name of the person responsible for the quarantine, location of quarantined drug product, date of disposition, and ultimate disposition of the quarantined drug product.
Note: Authority cited; Sections 102, 208, 26202 and 26209, Health and Safety Code. Reference: Sections 26611, 26612 and 26689, Health and Safety Code.
s 10377.5. Requirements for the Establishment and Maintenance of Human Prescription Drug Records.
(a) Human prescription drug manufacturers shall establish and maintain inventories and records of all transactions regarding the disposal of human prescription drugs. These records shall include the following information:
(1) The identity and quantity of the human prescription drugs disposed of; and
(2) The dates of disposal of the human prescription drugs.
(b) Inventories and records of receipt, distribution, disposal, and other disposition of human prescription drugs, including records described in Section 10377.4(d) and (e), shall be made available for inspection and photocopying by the Department or any authorized federal, state, or local law enforcement agency officials for a period of at least three years following distribution, disposal, or other disposition.
(c) Inventories and records of receipt, distribution, disposal, and other disposition of human prescription drugs, including records described in Section 10377.4(d) and (e), that are kept at the inspection site or that can be immediately retrieved by computer or other electronic means shall be readily available for authorized inspection during the retention period. Records kept at a central location apart from the inspection site and not electronically retrievable shall be made available for inspection as soon as possible, but no later than two working days after a request by an authorized official of a federal, state, or local law enforcement agency.
(d) Human prescription drug manufacturers shall establish and maintain lists of officers, directors, managers, and other persons in charge of human prescription drug manufacturing, distribution, storage, and handling, including a description of their duties and a summary of their qualifications.
Note: Authority cited; Sections 102, 208, 26202 and 26209, Health and Safety Code. Reference: Sections 26611, 26612 and 26689, Health and Safety Code.
s 10377.6. Written Policies and Procedures for the Handling of Human Prescription Drugs.
(a) Human prescription drug manufacturers shall establish, maintain, and adhere to written policies and procedures, which shall be followed for the security and disposition of human prescription drugs including policies and procedures for identifying, recording, and reporting losses or thefts, and for correcting all errors and inaccuracies in inventories.
(b) Human prescription drug manufacturers shall include in their written policies and procedures the following:
(1) A procedure to be followed for handling recalls and withdrawals of human prescription drugs. This procedure shall be adequate to deal with recalls and withdrawals due to:
(A) Any action initiated at the request of the Department, the federal Food and Drug Administration or other federal, state, or local law enforcement or other government agency;
(B) Any voluntary action by the manufacturer to remove defective or potentially defective human prescription drugs from the market; or
(C) Any action undertaken to promote public health and safety by replacing existing merchandise with an improved product or new package design;
(2) A procedure to ensure that the manufacturer is prepared for, protected against, and is ready to handle any crisis that affects security or op eration of any facility in the event of fire, flood, or other natural disaster, or strike or other situations of local, state or national emergency; and
(3) A procedure to ensure that any outdated human prescription drugs shall be segregated from other drugs and destroyed. This procedure shall provide for written documentation of the disposition of outdated human prescription drugs. This documentation shall be maintained for at least three years after disposition of the outdated human prescription drugs.
Note: Authority cited; Sections 102, 208, 26202 and 26209, Health and Safety Code. Reference: Sections 26611, 26612 and 26689, Health and Safety Code.
s 10377.7. Inspection by Federal, State, and Local Law Enforcement Officials.
Human prescription drug manufacturers shall permit authorized federal, state, and local law enforcement officials to enter and inspect their premises and delivery vehicles, and to audit their records and written operating procedures, during business hours or any other reasonable times and in a reasonable manner, to the extent authorized by law.
Note: Authority cited: Sections 102, 208 and 26202, Health and Safety Code. Reference: Section 26689, Health and Safety Code.
s 10377.8. Manufacturers of Active Ingredient Components of Human Prescription Drugs.
(a) In addition to the regulations in this article, manufacturers of any active ingredient component of a human prescription drug shall comply with the following sections of Code of Federal Regulations, title 21, part 211 (revised as of April 1, 1992), except that all references to "drug product" shall apply to active ingredient components: sections 211.25 (Personnel qualifications), 211.28 (Personnel responsibilities), 211.42 (Design and construction features), 211.44 (Lighting), 211.46 (Ventilation, air filtration, air heating and cooling), 211.48(a) [first sentence] and (b) (Plumbing), 211.50 (Sewage and refuse), 211.52 (Washing and toilet facilities), 211.56 (Sanitation), 211.58(Maintenance), 211.63 (Equipment design, size, and location), 211.65 (Equipment construction), 211.67 (Equipment cleaning and maintenance), 211.68 (Automatic, mechanical, and electronic equipment), 211.142 (Warehousing procedures), 211.150 (Distribution procedures), 211.180(a), (c), (d), and (f) (General requirements), 211.182 (Equipment cleaning and use logs), 211.196 (Distribution records), 211.204 (Returned drug products), and 211.208 (Drug product salvaging).
(b) In the event that it is impossible for a manufacturer of a biological drug to comply with both this section and the federal regulations for the manufacture of biologic drugs, this section shall not apply to the extent that it conflicts with a federal regulation specifically applicable to the biological drug product in question.
Note: Authority cited: Sections 102, 208, 26202 and 26209, Health and Safety Code. Reference: Sections 26611, 26612 and 26689, Health and Safety Code.
s 10380. Labeling, Misbranding (26240).
s 10381. Label Non-Prescription Drugs. Pregnancy/Nursing.
(a) Any drug not subject to Section 26660 of the Health and Safety Code which is intended for systemic absorption into the human body shall include on the label the following statement:
"Caution: If pregnant or nursing a baby, consult your physician or pharmacist before using this product."
(b) Section 10381(a) shall not apply if such drug:
(1) Is intended for poison control purposes.
(2) Is labeled with information regarding use in pregnancy and nursing which is substantially similar to the statement required by Section 10381(a).
(3) Meets both of the following:
(A) It is intended to benefit the embryo, fetus or nursing infant during the period of pregnancy or lactation.
(B) It is labeled with specific directions for use during the period of pregnancy or lactation pursuant to federal or state requirements.
(4) Is not intended to be systemically absorbed.
(5) Is oxygen intended for emergency use.
(c) Any drug manufactured and labeled after 11-18-82 shall be misbranded if the information required by this section is not disclosed on the label.
Note: Authority cited: Sections 208 and 26202, Health and Safety Code. Reference: Sections 26400, 26630 and 26638, Health and Safety Code.
s 10385. Labeling Requirements (26241).
s 10386. Manufacturer of Finished Dosage Form.
The intent of this section is to assure that the advertising and labeling required by Section 26636(c) of the code provides sufficient useful information to pharmacists, physicians, and other purchasers of prescription drugs that they may identify certain persons participating in the manufacturing of the finished dosage form of such drug(s). These regulations are in addition to the regulations of other sections of the Sherman Food, Drug, and Cosmetic Law regarding labeling and advertising requirements for drugs.
(a) For the purpose of this section the finished dosage form of a prescription drug is defined as that form of the drug which is or is intended to be dispensed or administered to the patient and requires no further manufacturing or processing other than packaging and labeling.
(b) For the purpose of this section only, the term "drug" shall include only those articles as defined in Section 26010 of the Act which achieve their principal intended purposes through chemical action within or on the body of man or other animals or which are metabolized in the achievement of these purposes.
(c) For the purpose of this section the term "manufacturer" means persons who "manufacture" as that term is defined by Section 26019 of the Health and Safety Code.
(d) For the purpose of this section the term advertisement shall have the same definition as Section 26002 of the Health and Safety Code.
(e) The labeling and advertising for any prescription drug, including those whose label states "distributed by . . ." or similar language, must contain the name and place of business of the manufacturer who mixed the final ingredients, and the manufacturer who encapsulated (if in capsule form) or tableted (if in tablet form) the finished dosage form, qualified by such phrases as "final ingredients mixed by . . .," "encapsulated by . . .," "tableted by . . .," or words of similar or like meaning that express the facts. The presence of the name and address of only one manufacturer shall mean that only the named firm mixed the final ingredients and encapsulated (if in capsule form) or tableted (if in tablet form) the finished dosage form.
(f) The requirement for declaration of the name of the manufacturer of the finished dosage form shall be deemed to be satisfied in the case of a corporation only by the actual corporate name which may be preceded or followed by the name of the particular division of the corporation. Abbreviations for "Company," "Incorporated," etc., may be used and "The" may be omitted. In the case of an individual, partnership, or association, the name under which the business is conducted shall be used. The statement of the place of business shall include the street address, city, state, and zip code; however, the street address may be omitted if it is shown in a current city directory or telephone directory.
(g) For the purposes of this section, all products subject to this section will be deemed to be misbranded if the name and place of business of each manufacturer as described in the foregoing subsections of this regulation is not included in the labeling on, or within the package from which the drug is dispensed and in all advertising of such product intended primarily for dissemination to California practitioners.
Note: Authority cited: Sections 208 and 26202, Health and Safety Code. Reference: Section 26636, Health and Safety Code.
s 10390. Forms of Making Required Statements (26242).
s 10395. Statements of Ingredients and Proportions (26243).
s 10400. Hoxsey Method for Treatment of Cancer.
(a) The Hoxsey method is a cancer treatment system which employs the use of the substances potassium iodide, lactated pepsin, red clover blossoms, cascara sagrada, licorice, burdock root, stillingia root, berberis root, poke root, echinacea root, prickly ash bark, and buckthorn bark, either singly or in combination with each other.
(b) The prescription, administration, sale or other distribution of Hoxsey agents, or any of the ingredients described in subsection (a) of this section, whether singly or in any combination, or in any dosage or guise whatever, in the diagnosis, alleviation, treatment or cure of cancer, or for treatment of any patient who has or who believes he or she has or who may have cancer is prohibited, except as provided by Section 1708 of the Health and Safety Code.
(c) No person shall, for the purpose of prescribing, administering, selling or otherwise distributing any or all ingredients of the Hoxsey formula, make any representation that said Hoxsey method for the treatment of cancer, or any of the ingredients described in subsection (a) of this section, whether singly or in any combination or in any guise whatever, has any value in arresting or curing cancer.
Note: Authority cited: Sections 208 and 1704, Health and Safety Code. Reference: Section 1704, Health and Safety Code.
s 10400.1. Beta-Cyanogenetic Glucosides ( "Laetriles") Agent for Treatment of Cancer.
(a) The Department of Public Health has carefully considered a document entitled "A Report on the Treatment of Cancer with Beta-Cyanogenetic Glucosides ('Laetriles')" dated May 20, 1963, and is satisfied beyond a reasonable doubt that the findings therein are true. The Department hereby ratifies and adopts said report as its own and a copy of same is on file with the California State Department of Public Health and is available for public inspection at its office located at 2151 Berkeley Way, Berkeley, California.
(b) The Department of Public Health hereby finds that beta-cyanogenetic glucosides including amygdalin (with or without the addition of diisopropyl ammonium iodide), and prunasin, commonly known as "Laetriles," are of no value in the diagnosis, treatment, alleviation or cure of cancer and that the use of one or more of these agents in early cancer to the exclusion of conventional treatment might well be dangerous since treatment with acceptable, modern, curative methods (surgery or radiation) would thereby be delayed potentially until such time as metastases had occurred and the cancer therefore might no longer be curable. In late disease palliative effect is lacking. The Department recommends that the public refrain from using any of the said agents or any agent, drug, medicine, compound or device substantially similar thereto in the diagnosis, alleviation, treatment or cure of cancer.
(c) Except as otherwise provided in Section 1708 of the California Health and Safety Code the prescription, administration, sale or other distribution of beta-cyanogenetic glucosides including amygdalin (with or without the addition of diisopropyl ammonium iodide) and prunasin, commonly known as "Laetriles" or, any substantially similar agent, drug, medicine, compound or device to any patient who has or who believes that he has or may have cancer is prohibited; and the Department shall upon learning of such prescription, administration, sale or other distribution take appropriate steps to cause such persons so doing to cease and desist therefrom.
(d) No person shall for the purpose of prescribing, administering, selling or otherwise distributing beta-cyanogenetic glucosides including amygdalin (with or without the addition of diisopropyl ammonium iodide) or prunasin, commonly known as "Laetriles," make any representation that said agents have any value in arresting, alleviating or curing cancer; and the Department shall upon learning of such representation take appropriate steps to cause such person to cease and desist from such re presentation and shall take such other and further steps as may be appropriate to cause such representation to be discontinued.
Note: Authority cited: Sections 102 and 208, Health and Safety Code. Reference: Section 1704, Health and Safety Code.
s 10400.2. Bolen Test for Diagnosis of Cancer.
(a) As used in this section, the Bolen test means the determination of malignancy by the clotting patterns of a drop of blood as described and defined in the report entitled REPORT, FINDINGS AND RECOMMENDATIONS of the CALIFORNIA CANCER ADVISORY COUNCIL to DIRECTOR, CALIFORNIA STATE DEPARTMENT OF PUBLIC HEALTH, 2151 Berkeley Way, Berkeley 4, California, with respect to the DIAGNOSIS OF CANCER WITH THE BOLEN TEST dated April 17, 1963.
(b) Except as otherwise provided in Section 1708 of the Health and Safety Code, the administration of the Bolen test or any substantially similar test for the diagnosis of cancer in any patient who has or who believes that he or she has or who may have cancer is prohibited.
(c) No person shall, for the purpose of administering the Bolen test make any representation that it has any value in diagnosing cancer.
Note: Authority cited: Sections 208 and 1704, Health and Safety Code. Reference, Section 1704, Health and Safety Code.
s 10400.3. Koch Agents for Treatment of Cancer.
(a) As used in this section, the Koch agents mean those agents described and defined in the report entitled REPORT, FINDINGS AND RECOMMENDATIONS of the CALIFORNIA CANCER ADVISORY COUNCIL to DIRECTOR, CALIFORNIA STATE DEPARTMENT OF PUBLIC HEALTH, 2151 Berkeley Way, Berkeley 4, California, with respect to THE TREATMENT OF CANCER WITH THE KOCH SYNTHETIC ANTITOXINS -(Malonide, Glyoxylide and Parabenzoquinone) dated April 17, 1963, which agents are commonly known as Malonide, Glyoxylide and Parabenzoquinone and are further commonly collectively known as the Koch agents.
(b) Except as otherwise provided in Section 1708 of the Health and Safety Code the prescription, administration, sale or other distribution of the three Koch agents, as defined in subsection (a) of this section, or any agents substantially similar thereto, whether singly or in any combination, or in any dosage or guise whatever, in the diagnosis, alleviation, treatment or cure of cancer, or for treatment of any patient who has or who believes that he or she has or who may have cancer is prohibited.
(c) No person shall, for the purpose of prescribing, administering, selling or otherwise distributing any or all of the Koch agents, make any representation that the Koch agents, whether singly or in any combination or in any guise whatever, have any value in arresting, alleviating, or curing cancer.
Note: Authority cited: Sections 208 and 1704, Health and Safety Code. Reference: Section 1704, Health and Safety Code.
s 10400.4. Lincoln Staphage Lysate Agent for Treatment of Cancer.
(a) As used in this section, Lincoln Staphage Lysate means that agent described and defined in the report entitled REPORT, FINDINGS AND RECOMMENDATIONS of the CALIFORNIA CANCER ADVISORY COUNCIL to DIRECTOR, CALIFORNIA STATE DEPARTMENT OF PUBLIC HEALTH, 2151 Berkeley Way, Berkeley 4, California, with respect to THE TREATMENT OF CANCER WITH LINCOLN STAPHAGE LYSATE, dated April 17, 1963, which agent consists of staphylococcus bacteriophage lysates, alpha and beta is commonly known as Lincoln Staphage Lysate.
(b) Except as otherwise provided in Section 1708 of the Health and Safety Code the prescription, administration, sale or other distribution of Lincoln Staphage Lysate, as defined in subsection (a) of this section, or any agent substantially similar thereto, in the diagnosis, alleviation, treatment or cure of cancer, or for the treatment of any patient who has or who believes that he or she has or who may have cancer is prohibited.
(c) No person shall, for the purpose of prescribing, administering, selling or otherwise distributing Lincoln Staphage Lysate, make any representation that it has any value in arresting, alleviating or curing cancer.
Note: Authority cited: Sections 208 and 1704, Health and Safety Code. Reference: Section 1704, Health and Safety Code.
s 10400.5. Mucorhicin Agent for Treatment of Cancer.
(a) As used in this section, Mucorhicin means that agent, consisting of a mold substrate containing generic forms of Mucor, Rhizopus and various strains of penicillium, as described and defined in the report entitled REPORT, FINDINGS, AND RECOMMENDATIONS of the CALIFORNIA CANCER ADVISORY COUNCIL to DIRECTOR, CALIFORNIA STATE DEPARTMENT OF PUBLIC HEALTH, 2151 Berkeley Way, Berkeley 4, California, with respect to THE TREATMENT OF CANCER WITH MUCORHICIN, dated April 17, 1963.
(b) Except as otherwise provided in Section 1708 of the Health and Safety Code the prescription, administration, sale or other distribution of Mucorhicin, as defined in subsection (a) of this section, or any agent substantially similar thereto, in any dosage or guise whatever, in the diagnosis, alleviation, treatment or cure of cancer, or for the treatment of any patient who has or who believes that he or she has or who may have cancer is prohibited.
(c) No person shall, for the purpose of prescribing, administering, selling or otherwise distributing Mucorhicin, make any representation that Mucorhicin in any dosage or in any guise whatever, has any value in arresting, alleviating or curing cancer.
Note: Authority cited: Sections 208 and 1704, Health and Safety Code. Reference: Section 1704, Health and Safety Code.
s 10400.6. Anthrone Test for Diagnosis of Cancer.
(a) As used in this section, the Anthrone test means the determination of the presence or degree of malignancy by the purported determination of the 24 hour level of chorionic gonadotropin excretion in urine as such method is described and defined in the report entitled in part REPORT, FINDINGS AND RECOMMENDATIONS of the CALIFORNIA CANCER ADVISORY COUNCIL with respect to the DIAGNOSIS OF CANCER WITH THE ANTHRONE TEST dated August 17, 1964.
(b) Except as otherwise provided in Section 1708 of the Health and Safety Code, the use of the Anthrone test, as described in subsection (a) of this section, or any test substantially similar thereto for the diagnosis of cancer in any patient who has or who believes that he has or who may have cancer is prohibited.
(c) No person shall, for the purpose of using the Anthrone test in any guise whatever, make any representation that it has any value in diagnosing cancer.
Note: Authority cited: Sections 208 and 1704, Health and Safety Code. Reference: Section 1704, Health and Safety Code.
s 10400.7. Krebiozen for Treatment of Cancer.
(a) As used in this section Krebiozen means that agent described and defined in the report entitled REPORT, FINDINGS AND RECOMMENDATIONS OF THE CANCER ADVISORY COUNCIL with respect to THE TREATMENT OF CANCER WITH KREBIOZEN dated May 27, 1964 and the supplementary report of said Council dated September 12, 1967.
(b) Except as otherwise provided in Section 1708 of the Health and Safety Code, the prescription, administration, sale or other distribution of Krebiozen, as defined in subsection (a) of this section, or any substantially similar agent, drug, medicine, compound or device to any patient who has or who believes he or she has or who may have cancer is prohibited.
(c) No person shall, for the purpose of prescribing, administering, selling or otherwise distributing Krebiozen, make any representation that said agent has any value in arresting, alleviating or curing cancer.
Note: Authority cited: Sections 208 and 1704, Health and Safety Code. Reference: Section 1704, Health and Safety Code.
s 10401. Drugs for Use in the Diagnosis, Treatment, Alleviation or Cure of Cancer in Human Beings.
Note: Authority cited: Sections 102, 208 and 1704(a), Health and Safety Code. Reference: Sections 1707.1-1707.7, Health and Safety Code.
s 10401.1. Investigation of Various Agents for the Diagnosis or Treatment of Cancer.
Experts wishing to investigate the value of drugs, medicines, compounds or devices in the diagnosis or treatment of cancer under the exemption provisions of Section 1708 of the Health and Safety Code shall provide the following information, in 20 copies, to the Department for approval prior to initiating the investigation.
(a) A sample of the labeling of the drug, medicine, compound or device which shall include the name, quantity, lot number of the agent and name of manufacturer and also a statement "Caution: New drug (or medicine or compound or device). Use in the diagnosis, treatment, alleviation or cure of cancer limited by law to investigational use."
(b) If the animal testing required by subsection (b) of 1708 has been done by or under the auspices of a person other than the applicant and the latter wishes to use the results of such testing as a part of his request for approval of the investigation, a signed authorization for use of the results from the person or persons responsible for such testing shall be provided.
(c) The written statement signed by the expert shall show what facilities the expert will use for the investigation to be conducted by him; that the drug, medicine, compound or device will be used solely by him or under his direction for the investigation; and shall contain information identifying any assistant or agent of the expert who uses the drug, medicine, compound or device under the direction of the expert. It shall also include a study plan for the investigation to show that a significant number of cases and controls are to be studied, the duration of the study and all other details of the plan; a sworn statement that the agent is to be used solely for investigational purposes without compensation or profit; and a detailed outline of the training and experience of the expert, this latter requirement being met by submission of a curriculum vitae and a list of publications. Criteria for evaluation of effect shall be those adopted by the Cancer Advisory Council on April 12, 1967.
(d) A copy of the consent form required by subsection (f) of 1708.
(e) An acknowledgment that complete records will be kept.
Note: Authority cited: Sections 208 and 1704(a), Health and Safety Code. Reference: Sections 1707.1 through 1707.5, Health and Safety Code.
s 10401.2. American Board of Oncology.
Note: Authority cited: Section 208, Health and Safety Code. Reference: Section 1708.5, Health and Safety Code (Chapter 1130, Statutes of 1980).
s 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.
Note: Authority cited: Sections 208 and 26202, Health and Safety Code. Reference: Sections 26638 and 26662, Health and Safety Code.
s 10409. Prescription Ophthalmic Devices.
The quality standards for prescription ophthalmic devices shall be the 1972 standards of the American National Standards Institute Z80.1 and Z80.2.
Note: Authority cited: Section 2541.3, Business and Professions Code; and Section 208, Health and Safety Code. Reference: Section 2541.3, Business and Professions Code.
s 10410. Exemption for Prescription Devices.
A device which, because of any potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, is not safe except under the supervision of a practitioner licensed by law to direct the use of such device, and hence for which "adequate directions for use" cannot be prepared, shall be exempt from Section 26638 of the code if all the following conditions are met:
(a) The device is in the possession of a person (or agents or employees of the person) regularly and lawfully engaged in the manufacture, transportation, storage, or wholesale or retail distribution of such device and is to be sold only to or on the prescription or other order of such practitioner for use in the course of the practitioner's professional practice.
(b) The label of the device (other than surgical instruments) bears:
(1) The statement "Caution: Federal law restricts this device to sale by or on the order of a ________," or "Caution sale of this device is restricted to sale by or on the order of a ________." The blanks to be filled with the word "physician," "dentist," "veterinarian," or with the descriptive designation of any other practitioner licensed by the law of the State of California; and
(2) The method of its application or use.
Note: Authority cited: Sections 208 and 26202, Health and Safety Code. Reference: Sections 26638 and 26643, Health and Safety Code.
s 10415. Exemption for Prescription Drugs and Veterinary Drugs.
(a) Exemption for Prescription Drugs. A drug subject to the requirements of Section 26660 of the code, shall be exempt from Section 26638 if all the following conditions are met:
(1) The drug is:
(A) In the possession of a person (or agents or employees of the person) regularly and lawfully engaged in the manufacture, transportation, storage, or wholesale distribution of prescription drugs; or
(B) In the possession of a pharmacy or a public health agency, regularly and lawfully engaged in dispensing prescription drugs; and is to be dispensed in accordance with Section 26662.
(2) The label of the drug bears:
(A) The statement "Caution: Federal law prohibits dispensing without prescription," or "Caution: Not to be dispensed without a prescription"; and
(B) The recommended or usual dosage; and
(C) The route of administration, if it is not for oral use; and
(D) If it is fabricated from two or more ingredients and is not designated conspicuously by a name recognized in an official compendium the quantity or proportion of each active ingredient and if it is not for oral use the names of all other ingredients. Provided, however, that the information referred to in subdivisions (B), (C), and (D) of this subparagraph may be contained in the labeling on or within the package from which it is to be dispensed, and, in the case of ampuls, too small or otherwise unable to accommodate a label but which are packaged in a container from which they are withdrawn for dispensing or use, the information referred to in subdivision (A) of this subparagraph may be placed on the outside container only.
(3) The labeling of the drug (which may include brochures readily available to licensed practitioners) bears information as to the use of the drug by practitioners licensed by law to administer it: provided, however, that such information may be omitted from the labeling if it is contained in scientific literature widely disseminated among practitioners licensed by law to administer the drug.
(b) Exemption for Veterinary Drugs. A drug intended solely for veterinary use which, because of toxicity or other potentiality for harmful effect, or the method of its use, is not safe for animal use except under the supervision of a licensed veterinarian, and hence for which "adequate directions for use" cannot be prepared, shall be exempt from Section 26638 of the code if all the following conditions are met:
(1) The drug is in the possession of a person (or agents or employees of the person) regularly and lawfully engaged in the manufacture, transportation, storage, or wholesale or retail distribution of veterinary drugs and is to be sold only to or on the prescription or other order of a licensed veterinarian for use in the course of the veterinarian's professional practice.
(2) The label of a drug bears:
(A) The statement "Caution: Federal law restricts this drug to sale by or on the order of a licensed veterinarian," or "Caution: To be sold only by or on the order of a licensed veterinarian"; and
(B) The recommended or usual dosage; and
(C) The route of administration if it is not for oral use; and
(D) The quantity or proportion of each active ingredient if it is fabricated from two or more ingredients and is not designated conspicuously by a name recognized in an official compendium. Provided, however, that the information referred to in subdivisions (B), (C), and (D) of this subparagraph may be contained in the labeling on or within the package from which it is to be dispensed.
(3) The labeling of the drug (which may include brochures readily available to licensed veterinarians) bears information as to use of the drug by licensed veterinarians; provided, however, that such information may be omitted from the labeling if it is contained in scientific literature widely disseminated among veterinarians licensed by law to administer such drug.
Note: Authority cited: Sections 208 and 26202, Health and Safety Code. Reference: Sections 26660 and 26662, Health and Safety Code.
s 10416. Exemptions for Drugs Dispensed by Licensed Practitioners.
Note: Authority cited: Sections 102, 208 and 26202, Health and Safety Code.
s 10417. Formulary of Inequivalent Generic Drug Types and Drug Products for Which Substitution Poses a Threat to Health and Safety.
(a) The generic drug types or drug products listed in the formulary below have been determined, pursuant to Business and Professions Code Section 4047.7, to have demonstrated clinically significant biological or therapeutic inequivalence and which, if substituted in accordance with Business and Professions Code Section 4047.6, would pose a threat to the health and safety of patients receiving such medications.
FORMULARY
(1) Generic Drug Types
(2) Drug Products
(b) Any person requesting the inclusion, addition, or deletion of any generic drug type or drug product to the formulary shall submit such re quest to the Department of Health Services in accordance with the following:
(1) Submissions supporting the inclusion, addition, or deletion of any generic drug type or drug product to the formulary shall consist of evidence of adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific training and experience, on the basis of which it could be fairly and responsibly determined by the Director that a generic drug type or drug product demonstrates, or does not demonstrate, clinically significant biological or therapeutic inequivalence and which, if substituted for another drug product under the provisions of Section 4047.6 of the Business and Professions Code would pose a threat to the health and safety of patients receiving prescription medication.
(2) Submissions shall adequately identify all drug products involved by name of manufacturer, lot number(s), and dosage form(s) and should demonstrate the condition(s) of use (e.g., duration, frequency, etc.) of any such drug product where substitution poses a threat to the health and safety of the patient.
(3) Submissions shall be made in triplicate to Food and Drug Branch, Department of Health Services, Sacramento, CA 95814.
(4) Any information submitted shall be considered to be public information.
Note: Authority cited: Section 4047.7, Business and Professions Code. Reference: Sections 4047.6 and 4047.7, Business and Professions Code.
s 10420. Label Requirements (26254).
s 10425. Applications.
(a) Each new drug application submitted for filing with the Department shall be in duplicate. If any part of the application is in a foreign language, an accurate and complete English translation shall be appended to that part.
(b) An application shall not be accepted for filing if only one copy is submitted or if it is incomplete on its face in that:
(1) It does not contain all the matter required by clauses (1), (2), (3), (4) and (6), of Section 26670 of the code.
(2) It does not state the conditions under which the drug or device is to be used; or
(3) The specimen of labeling proposed for use upon or within the retail package does not expressly or by reference to a brochure or other printed matter prescribe, recommend, or suggest the use of the drug or device under such conditions.
(c) The date on which an application is received by the Department shall be considered to be the date on which the application is filed, and the Department shall notify the applicant of such date. If the applicant withdraws the application, it shall be considered as not having been filed.
(d) The applicant may file an amendment to an application which has been filed and is pending before the Department, but in that case the unamended application shall be considered as having been withdrawn and the amended application shall be considered as having been filed on the date on which the amendment is received by the Department. The Department shall notify the applicant of such date.
(e) After an application has become effective with respect to a drug or device the applicant may file a supplemental application with respect thereto setting forth any proposed change in the conditions under which the drug or device is to be used in the labeling thereof, in any circumstance relating to its production, or in any other information contained in the effective application. Such supplemental application may omit statements in the effective application concerning which no change is proposed.
Note: Authority cited: Sections 208 and 26202, Health and Safety Code. Reference: Section 26670, Health and Safety Code.
s 10430. Notification of Applicant (26289).
s 10435. Insufficient Information in Application (26290). (continued)