reglab/statecodes huggingface dataset:
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 5 - Sanitation (Environmental) › Subchapter 1 - Engineering (Sanitary) › Group 11 - FOOD CROP GROWING AND HARVESTING SANITATION › Article 4 - SERVICING OF UNITS › Section 8010 - Toilets

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
It shall be the responsibility of the employer to insure
						  that toilets are serviced and maintained in a clean, sanitary condition and kept in
						  good repair at all times.
1. New NOTE
						  filed 8-9-84 (Register 84, No. 32).
Note: Authority cited: Sections
							 208 and
							 5474.29,
							 Health and Safety Code. Reference: Section
							 5474.25,
							 Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 5 - Sanitation (Environmental) › Subchapter 1 - Engineering (Sanitary) › Group 11 - FOOD CROP GROWING AND HARVESTING SANITATION › Article 5 - SUPPLIES › Section 8011 - Toilet Paperholder

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
Toilet paper shall be provided in a suitable holder in each
						  toilet unit.
1. Amendment
						  filed 8-6-85; effective thirtieth day thereafter (Register 85, No.
						  32).
Note: Authority cited: Sections
							 208 and
							 5474.29,
							 Health and Safety Code. Reference: Section
							 5474.25,
							 Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 5 - Sanitation (Environmental) › Subchapter 1 - Engineering (Sanitary) › Group 11 - FOOD CROP GROWING AND HARVESTING SANITATION › Article 6 - HANDWASHING FACILITIES › Section 8012 - Standards

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1.
						  Renumbering and amendment of Section T17-8012 to Section
						  8008 filed 8-6-85; effective thirtieth
						  day thereafter (Register 85, No. 32).
Note: Authority cited: Sections
							 208 and
							 5474.29,
							 Health and Safety Code. Reference: Section
							 5474.26,
							 Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 5 - Sanitation (Environmental) › Subchapter 1 - Engineering (Sanitary) › Group 11 - FOOD CROP GROWING AND HARVESTING SANITATION › Article 7 - WASTE WASH WATER DISPOSAL › Section 8013 - Water Flush Toilets and Handwashing Facilities

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
Water flush toilets and handwashing facilities shall conform
						  to the (Compiled) State Building Standards Code, Part 5, Title 24, California
						  Administrative Code.
1. Repealer
						  and new section filed 8-6-85; effective thirtieth day thereafter (Register 85, No.
						  32).
Note: Authority cited: Sections
							 208 and
							 5474.29,
							 Health and Safety Code. Reference: Section
							 5474.25,
							 Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 5 - Sanitation (Environmental) › Subchapter 1 - Engineering (Sanitary) › Group 12 - RECLAIMED WASTE WATER › Section 8025 - Intent

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. New Group 12
						(Sections 8025 through
						8050) filed 5-20-68; effective
						thirtieth day thereafter (Register 68, No. 20).
2. Repealer of Group 12
						(Sections 8025-8050) filed 4-2-75; effective
						thirtieth day thereafter (Register 75, No. 14).
Note: Authority cited for Group 12: Section
						  102,
						  Health and Safety Code. Reference: Section
						  13521, Water
						  Code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 5 - Sanitation (Environmental) › Subchapter 1.5 - Regulations for Implementation of the California Environmental Quality Act of 1970

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(Originally Printed 7-21-73)
1. New Subchapter
				  1.5 (Sections 8100-8113.5) filed 7-20-73; effective
				  thirtieth day thereafter (Register 73, No. 29).
2. Amendment filed
				  11-21-79; effective thirtieth day thereafter (Register 79, No. 47).
3.
				  Repealer of Subchapter 1.5 (Sections
				  8100-8113.5) filed 10-12-83; effective
				  thirtieth day thereafter (Register 83, No. 42).
Note: Authority cited: Section
					 208,
					 Health and Safety Code, and Section
					 21082,
					 Public Resources Code. Reference: Section
					 21000 et seq., Public Resources
					 Code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 5 - Sanitation (Environmental) › Subchapter 2 - Foods and Drugs › Group 1 - RULES AND REGULATIONS › Section 10101 - Order Promulgating Regulations

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
Under the authority of Sections
						200
						through
						208,
						26321,
						26542,
						28013,
						28153,
						28182,
						28243,
						28339,
						28440,
						28508,
						28663.5
						and
						28709 of
						the Health and Safety Code, and Section
						1147 of the Agricultural Code, the
						following regulations for the enforcement of Division 21 of the Health and Safety
						Code are hereby promulgated.
These regulations shall take effect on September 1,
						1954.
The regulations now in force are hereby repealed as of the
						date the new regulations herein promulgated shall become
						effective.
1. Originally
						printed August 15, 1945 (Title 17).
2. For repealers, added sections,
						amendments and revisions of former subchapter 2, refer to Registers 8, No. 3; 10,
						No. 6; 13, No. 2; 16, No. 5; 17, No. 2; 18, No. 4; 19, No. 2; 20, No. 1; and 26, No.
						3.
3. Repealer and new subchapter 2 filed 7-29-54; designated effective
						9-1-54 (Register 54, No. 16).
Note: Authority cited for subchapter 2 filed 7-29-54:
						  Sections
						  200
						  through
						  208,
						  26321,
						  26542,
						  28013,
						  28153,
						  28182,
						  28243,
						  28339,
						  28440,
						  28508,
						  28663.5,
						  28709,
						  Health and Safety Code, and Section
						  1147, Agricultural
						  Code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 5 - Sanitation (Environmental) › Subchapter 2 - Foods and Drugs › Group 1 - RULES AND REGULATIONS › Section 10102 - General Regulations [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. Repealer
						filed 9-1-78; effective thirtieth day thereafter (Register 78, No.
						35).
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 5 - Sanitation (Environmental) › Subchapter 2 - Foods and Drugs › Group 1 - RULES AND REGULATIONS › Section 10103 - Constitutionality

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
If any section, subsection, clause, sentence, or phrase of
						these regulations or standards is for any reason held to be invalid or
						unconstitutional, such decision shall not affect the remaining portions of these
						regulations or standards. The State Board of Public Health hereby declares that it
						would have adopted the remaining portions of these regulations or standards
						irrespective of the fact, that any such section, subsection, clause, sentence, or
						phrase of these regulations or standards be declared invalid or
						unconstitutional.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 5 - Sanitation (Environmental) › Subchapter 2 - Foods and Drugs › Group 1 - RULES AND REGULATIONS › Section 10150 - Cosmetic Regulations [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. Repealer
						filed 9-1-78; effective thirtieth day thereafter (Register 78, No.
						35).
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 5 - Sanitation (Environmental) › Subchapter 2 - Foods and Drugs › Group 1 - RULES AND REGULATIONS › Article 1 - DEFINITIONS › Section 10200 - Dietary Supplement

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a)
						"Dietary supplement"
(1) Means an article (other
						than tobacco) intended to supplement the diet that bears or contains one or more of
						the following dietary ingredients:
(A) A
						vitamin,
(B) A mineral,
(C) An herb or other botanical,
(D) An amino acid,
(E) A dietary substance for use by humans to
						supplement the diet by increasing the total dietary intake, or
(F) A concentrate, metabolite, constituent,
						extract, or combination of any ingredient described in clause (A), (B), (C), (D), or
						(E);
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 5 - Sanitation (Environmental) › Subchapter 2 - Foods and Drugs › Group 1 - RULES AND REGULATIONS › Article 2 - DRUGS AND DEVICES REGULATIONS › Drugs and Devices › Section 10350 - Labeling Defined (26207) [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. Repealer
							 filed 9-1-78; effective thirtieth day thereafter (Register 78, No.
							 35).
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 5 - Sanitation (Environmental) › Subchapter 2 - Foods and Drugs › Group 1 - RULES AND REGULATIONS › Article 2 - DRUGS AND DEVICES REGULATIONS › Drugs and Devices › Section 10355 - Truth of Labeling (26208) [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. Repealer
							 filed 9-1-78; effective thirtieth day thereafter (Register 78, No.
							 35).
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 5 - Sanitation (Environmental) › Subchapter 2 - Foods and Drugs › Group 1 - RULES AND REGULATIONS › Article 2 - DRUGS AND DEVICES REGULATIONS › Drugs and Devices › Section 10360 - New Drugs -Definition

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
Newness of a drug may arise by reason (among other
							 reasons) of:
(a) The newness for drug use
						  of any substance which composes such drug, in whole or in part, whether it be an
						  active substance or a menstruum, excipient, carrier, coating, or other
						  component;
(b) The newness for drug use
						  of a combination of two or more substances, none of which is a new drug;
(c) The newness for drug use of the proportion of
						  a substance in a combination, even though such combination containing such substance
						  in other proportion is not a new drug;
(d) The newness of use of such drug in diagnosing,
						  curing, mitigating, treating, or preventing a disease, or to affect a structure or
						  function of the body, even though such drug is not a new drug when used in another
						  disease or to affect another structure or function of the body; or
(e) The newness of a dosage, or method or duration
						  of administration or application, or other condition of use prescribed, recommended,
						  or suggested in the labeling of such drug, even though such drug when used in other
						  dosage, or other method or duration of administration or application, or different
						  condition, is not a new drug.
1.
							 Amendment filed 6-27-60; effective thirtieth day thereafter (Register 60, No.
							 15).
2. Amendment of section heading and repealer of subsection (f) filed
							 12-17-85; effective thirtieth day thereafter (Register 85, No. 51).
3.
							 Governor Newsom issued Executive Order N-68-20 (2019 CA EO 68-20), dated June 5,
							 2020, relating to the temporary registrations allowing entities to manufacture
							 over-the-counter drugs or medical devices, due to the COVID-19
							 pandemic.
Note: Authority cited: Sections
								208 and
								26202,
								Health and Safety Code. Reference: Section
								26021,
								Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 5 - Sanitation (Environmental) › Subchapter 2 - Foods and Drugs › Group 1 - RULES AND REGULATIONS › Article 2 - DRUGS AND DEVICES REGULATIONS › Drugs and Devices › Section 10365 - Drugs - Name (26230) [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. Repealer
							 filed 12-17-85; effective thirtieth day thereafter (Register 85, No.
							 51).
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 5 - Sanitation (Environmental) › Subchapter 2 - Foods and Drugs › Group 1 - RULES AND REGULATIONS › Article 2 - DRUGS AND DEVICES REGULATIONS › Drugs and Devices › Section 10370 - Poisonous Insecticides and Rodenticides, Use of (26234(2)) [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. Repealer
							 filed 9-1-78; effective thirtieth day thereafter (Register 78, No.
							 35).
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 5 - Sanitation (Environmental) › Subchapter 2 - Foods and Drugs › Group 1 - RULES AND REGULATIONS › Article 2 - DRUGS AND DEVICES REGULATIONS › Drugs and Devices › Section 10371 - Drugs: Current Good Manufacturing Practice in Manufacture, Processing, Packaging, Labeling or Holding (26234(3)) [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. New
							 section filed 1-3-66; effective thirtieth day thereafter (Register 66, No.
							 1).
2. Repealer filed 9-1-78; effective thirtieth day thereafter
							 (Register 78, No. 35).
Note: Authority cited: Sections
								102 and
								208,
								Health and Safety Code. Reference: Section
								26234(3),
								Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 5 - Sanitation (Environmental) › Subchapter 2 - Foods and Drugs › Group 1 - RULES AND REGULATIONS › Article 2 - DRUGS AND DEVICES REGULATIONS › Drugs and Devices › Section 10375 - Blending of Certified Coal Tar Colors (26235 (2)) [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1.
							 Amendment filed 8-17-56; effective thirtieth day thereafter (Register 56, No.
							 16).
2. Repealer filed 12-17-85; effective thirtieth day thereafter
							 (Register 85, No. 51).
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 5 - Sanitation (Environmental) › Subchapter 2 - Foods and Drugs › Group 1 - RULES AND REGULATIONS › Article 2 - DRUGS AND DEVICES REGULATIONS › Drugs and Devices › Section 10377 - Definitions

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) The definitions set
						  forth in this Section apply to Sections
						  10376 through
						  10377.8 only.
(b) Blood means whole blood collected from a
						  single donor and processed either for transfusion or further
						  manufacturing.
(c) Blood component means
						  that part of blood separated by physical or mechanical means.
(d) Controlled Substance means, unless otherwise
						  specified, a drug, substance, or immediate precursor which is listed in any schedule
						  in Health and Safety Code Sections
						  11054,
						  11055,
						  11056,
						  11057,
						  or
						  11058,
						  or which is regulated as a controlled substance under the Controlled Substances Act
						  (21 U.S.C. §
														801 et seq.) or the Controlled Substances Import
						  and Export Act (21 U.S.C. §
														951 et seq.).
(e) Drug sample means a unit of a human
						  prescription drug that is not intended to be sold and is intended to promote the
						  sale of the drug.
(f) Human prescription
						  drug means any drug intended for human use required by State law to be dispensed
						  only by a prescription, including finished dosage forms and active ingredients
						  subject to Section
						  26660 of
						  the Health and Safety Code.
(g) Active
						  ingredient means any component that is intended to furnish pharmacological activity
						  or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention
						  of disease, or to affect the structure of any function of the body of man, including
						  those components that may undergo chemical change in the manufacture of the drug
						  product and be present in the drug product in a modified form intended to furnish
						  the specified activity or effect.
(h)
						  Component means any ingredient intended for use in the manufacture of a drug
						  product, including those that may not appear in the drug product.
(i) Manufacturer means any person who prepares,
						  compounds, propagates, processes, or fabricates any drug. The term manufacturer
						  includes anyone who repackages or otherwise changes the container, wrapper, or
						  labeling of any drug in furtherance of the distribution of the drug. The term
						  manufacturer does not include:
(1) A retailer who
						  repackages from a bulk container at the time of sale to its ultimate consumer;
						  or
(2) Anyone who sells, purchases, or
						  trades blood or blood components intended for transfusion, provided that the blood
						  or blood components are prepared using physical or mechanical means, not chemical
						  processes.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 5 - Sanitation (Environmental) › Subchapter 2 - Foods and Drugs › Group 1 - RULES AND REGULATIONS › Article 2 - DRUGS AND DEVICES REGULATIONS › Drugs and Devices › Section 10377.1 - Qualifications

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) A license to
						  manufacture human prescription drugs may be denied on the ground that the license
						  applicant is not qualified by reason of the applicant's experience to manufacture
						  and distribute human prescription drugs in a safe manner and in compliance with
						  federal, state, and local drug laws. In the case of a partnership, association, or
						  corporation, an applicant's experience includes the experience of each person whose
						  name is required to be included in the license application. An applicant's
						  experience includes, but is not limited to, the following factors:
(1) Any conviction of the applicant under any
						  federal, state, or local laws relating to drugs, including drug samples, wholesale
						  or retail drug distribution, or distribution of controlled substances;
(2) Any felony conviction of the applicant under
						  federal, state, or local laws which is substantially or rationally related to the
						  qualifications, functions, and duties of a licensed human prescription drug
						  manufacturer; a crime shall be considered substantially or rationally related to
						  qualifications, functions, or duties of human prescription drug manufacturer if,
						  reasonably or to a substantial degree, it evidences present or potential unfitness
						  of a licensee to perform the functions authorized by the license in a manner
						  consistent with the public health, safety, or welfare.
(3) The applicant's past experience in the
						  manufacture or distribution of drugs, including controlled substances;
(4) The furnishing by the applicant of false or
						  fraudulent material in any application made in connection with drug manufacturing or
						  distribution;
(5) Suspension or
						  revocation by federal, state, or local government of any license or permit currently
						  or previously held by the applicant for the manufacture or distribution of any
						  drugs, including controlled substances;
(6) Compliance with licensing requirements under
						  drug or device licenses previously granted by the Department, if any;
(7) Compliance with requirements to maintain
						  and/or make available to the Department those records required under the Sherman
						  Food, Drug, and Cosmetic Law (Health and Saf. Code §
														26000 et seq.) and the regulations
						  adopted pursuant to that law;
(8)
						  Compliance with requirements to make available to federal, state, or local law
						  enforcement officials those records described in 21 Code of Federal Regulations
						  section 205.50 (55 Fed. Reg. 38025-38026 (Sept.
						  14, 1990)); and
(9) History of addiction
						  or habitual use of any controlled substance, narcotic, prescription drug, or
						  alcoholic beverage.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 5 - Sanitation (Environmental) › Subchapter 2 - Foods and Drugs › Group 1 - RULES AND REGULATIONS › Article 2 - DRUGS AND DEVICES REGULATIONS › Drugs and Devices › Section 10377.2 - Revocation and Suspension

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) Any
						  conviction of any violation of federal, state, or local drug laws shall be grounds
						  for suspending or revoking a license to manufacture human prescription
						  drugs.
(b) Any action or conduct which
						  would have warranted denial of a license to manufacture human prescription drugs
						  shall be grounds for suspending or revoking a license to manufacture human
						  prescription drugs.
1. New
							 section filed 9-25-92 as an emergency; operative 9-25-92 (Register 92, No. 39). A
							 Certificate of Compliance must be transmitted to OAL 1-25-93 or emergency language
							 will be repealed by operation of law on the following day.
2. New section
							 refiled 1-20-93 as an emergency; operative 1-26-93 (Register 93, No. 4). A
							 Certificate of Compliance must be transmitted to OAL 5-26-93 or emergency language
							 will be repealed by operation of law on the following day.
3. Editorial
							 correction of HISTORY 2. (Register 93, No. 20).
4. Certificate of
							 Compliance as to 1-20-93 order transmitted to OAL 5-26-93 and filed 7-8-93 (Register
							 93, No. 28).
Note: Authority cited: Sections
								102,
								208 and
								26202,
								Health and Safety Code. Reference: Sections
								26688,
								26689,
								26691
								and
								26801,
								Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 5 - Sanitation (Environmental) › Subchapter 2 - Foods and Drugs › Group 1 - RULES AND REGULATIONS › Article 2 - DRUGS AND DEVICES REGULATIONS › Drugs and Devices › Section 10377.3 - Compliance

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
Human prescription drug manufacturers and their officers,
							 agents, representatives, and employees shall comply with the requirements of
							 Sections 10377.4,
							 10377.5,
							 10377.6,
							 10377.7, and
							 10377.8 relating to human prescription
							 drugs.
1. New
							 section filed 9-25-92 as an emergency; operative 9-25-92 (Register 92, No. 39). A
							 Certificate of Compliance must be transmitted to OAL 1-25-93 or emergency language
							 will be repealed by operation of law on the following day.
2. New section
							 refiled 1-20-93 as an emergency; operative 1-26-93 (Register 93, No. 4). A
							 Certificate of Compliance must be transmitted to OAL 5-26-93 or emergency language
							 will be repealed by operation of law on the following day.
3. Editorial
							 correction of HISTORY 2. (Register 93, No. 20).
4. Certificate of
							 Compliance as to 1-20-93 order transmitted to OAL 5-26-93 and filed 7-8-93 (Register
							 93, No. 28).
Note: Authority cited; Sections
								102,
								208,
								26202
								and
								26209,
								Health and Safety Code. Reference: Sections
								26611,
								26612
								and
								26689,
								Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 5 - Sanitation (Environmental) › Subchapter 2 - Foods and Drugs › Group 1 - RULES AND REGULATIONS › Article 2 - DRUGS AND DEVICES REGULATIONS › Drugs and Devices › Section 10377.4 - Requirements for the Storage and Handling of Human Prescription Drugs

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(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.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 5 - Sanitation (Environmental) › Subchapter 2 - Foods and Drugs › Group 1 - RULES AND REGULATIONS › Article 2 - DRUGS AND DEVICES REGULATIONS › Drugs and Devices › Section 10377.5 - Requirements for the Establishment and Maintenance of Human Prescription Drug Records

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(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.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 5 - Sanitation (Environmental) › Subchapter 2 - Foods and Drugs › Group 1 - RULES AND REGULATIONS › Article 2 - DRUGS AND DEVICES REGULATIONS › Drugs and Devices › Section 10377.6 - Written Policies and Procedures for the Handling of Human Prescription Drugs

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(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;
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 5 - Sanitation (Environmental) › Subchapter 2 - Foods and Drugs › Group 1 - RULES AND REGULATIONS › Article 2 - DRUGS AND DEVICES REGULATIONS › Drugs and Devices › Section 10377.7 - Inspection by Federal, State, and Local Law Enforcement Officials

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
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.
1. New
							 section filed 9-25-92 as an emergency; operative 9-25-92 (Register 92, No. 39). A
							 Certificate of Compliance must be transmitted to OAL 1-25-93 or emergency language
							 will be repealed by operation of law on the following day.
2. New section
							 refiled 1-20-93 as an emergency; operative 1-26-93 (Register 93, No. 4). A
							 Certificate of Compliance must be transmitted to OAL 5-26-93 or emergency language
							 will be repealed by operation of law on the following day.
3. Editorial
							 correction of HISTORY 2. (Register 93, No. 20).
4. Certificate of
							 Compliance as to 1-20-93 order transmitted to OAL 5-26-93 and filed 7-8-93 (Register
							 93, No. 28).
Note: Authority cited: Sections
								102,
								208 and
								26202,
								Health and Safety Code. Reference: Section
								26689,
								Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 5 - Sanitation (Environmental) › Subchapter 2 - Foods and Drugs › Group 1 - RULES AND REGULATIONS › Article 2 - DRUGS AND DEVICES REGULATIONS › Drugs and Devices › Section 10377.8 - Manufacturers of Active Ingredient Components of Human Prescription Drugs

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(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.
1. New
							 section filed 9-25-92 as an emergency; operative 9-25-92 (Register 92, No. 39). A
							 Certificate of Compliance must be transmitted to OAL 1-25-93 or emergency language
							 will be repealed by operation of law on the following day.
2. New section
							 refiled 1-20-93 as an emergency; operative 1-26-93 (Register 93, No. 4). A
							 Certificate of Compliance must be transmitted to OAL 5-26-93 or emergency language
							 will be repealed by operation of law on the following day.
3. Editorial
							 correction of HISTORY 2. (Register 93, No. 20).
4. Certificate of
							 Compliance as to 1-20-93 order including amendment of newly designated subsection
							 (a) and new subsection (b) transmitted to OAL 5-26-93 and filed 7-8-93 (Register 93,
							 No. 28).
Note: Authority cited: Sections
								102,
								208,
								26202
								and
								26209,
								Health and Safety Code. Reference: Sections
								26611,
								26612
								and
								26689,
								Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 5 - Sanitation (Environmental) › Subchapter 2 - Foods and Drugs › Group 1 - RULES AND REGULATIONS › Article 2 - DRUGS AND DEVICES REGULATIONS › Drugs and Devices › Section 10380 - Labeling, Misbranding (26240) [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. Repealer
							 filed 9-1-78; effective thirtieth day thereafter (Register 78, No.
							 35).
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 5 - Sanitation (Environmental) › Subchapter 2 - Foods and Drugs › Group 1 - RULES AND REGULATIONS › Article 2 - DRUGS AND DEVICES REGULATIONS › Drugs and Devices › Section 10381 - Label Non-Prescription Drugs. Pregnancy/Nursing

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(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.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 5 - Sanitation (Environmental) › Subchapter 2 - Foods and Drugs › Group 1 - RULES AND REGULATIONS › Article 2 - DRUGS AND DEVICES REGULATIONS › Drugs and Devices › Section 10385 - Labeling Requirements (26241) [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. Repealer
							 filed 9-1-78; effective thirtieth day thereafter (Register 78, No.
							 35).
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 5 - Sanitation (Environmental) › Subchapter 2 - Foods and Drugs › Group 1 - RULES AND REGULATIONS › Article 2 - DRUGS AND DEVICES REGULATIONS › Drugs and Devices › Section 10390 - Forms of Making Required Statements (26242) [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. Repealer
							 filed 9-1-78; effective thirtieth day thereafter (Register 78, No.
							 35).
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 5 - Sanitation (Environmental) › Subchapter 2 - Foods and Drugs › Group 1 - RULES AND REGULATIONS › Article 2 - DRUGS AND DEVICES REGULATIONS › Drugs and Devices › Section 10395 - Statements of Ingredients and Proportions (26243) [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. Repealer
							 filed 9-1-78; effective thirtieth day thereafter (Register 78, No. 35). For prior
							 history, see Register 56, No. 16.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 5 - Sanitation (Environmental) › Subchapter 2 - Foods and Drugs › Group 1 - RULES AND REGULATIONS › Article 2 - DRUGS AND DEVICES REGULATIONS › Drugs and Devices › Section 10400 - Hoxsey Method for Treatment of Cancer

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(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.
1. New
							 section filed 10-1-62; effective thirtieth day thereafter (Register 62, No.
							 21).
2. Amendment filed 12-17-85; effective thirtieth day thereafter
							 (Register 85, No. 51).
Note: Authority cited: Sections
								208 and
								1704,
								Health and Safety Code. Reference: Section
								1704,
								Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 5 - Sanitation (Environmental) › Subchapter 2 - Foods and Drugs › Group 1 - RULES AND REGULATIONS › Article 2 - DRUGS AND DEVICES REGULATIONS › Drugs and Devices › Section 10400.2 - Bolen Test for Diagnosis of Cancer

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(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.
1. New
							 section filed 10-3-63; effective thirtieth day thereafter (Register 63, No.
							 17).
2. Amendment filed 12-17-85; effective thirtieth day thereafter
							 (Register 85, No. 51).
Note: Authority cited: Sections
								208 and
								1704,
								Health and Safety Code. Reference, Section
								1704,
								Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 5 - Sanitation (Environmental) › Subchapter 2 - Foods and Drugs › Group 1 - RULES AND REGULATIONS › Article 2 - DRUGS AND DEVICES REGULATIONS › Drugs and Devices › Section 10400.3 - Koch Agents for Treatment of Cancer

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(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.
1. New
							 section filed 10-3-63; effective thirtieth day thereafter (Register 63, No.
							 17).
2. Amendment filed 12-17-85; effective thirtieth day thereafter
							 (Register 85, No. 51).
Note: Authority cited: Sections
								208 and
								1704,
								Health and Safety Code. Reference: Section
								1704,
								Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 5 - Sanitation (Environmental) › Subchapter 2 - Foods and Drugs › Group 1 - RULES AND REGULATIONS › Article 2 - DRUGS AND DEVICES REGULATIONS › Drugs and Devices › Section 10400.4 - Lincoln Staphage Lysate Agent for Treatment of Cancer

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(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.
1. New
							 section filed 10-3-63; effective thirtieth day thereafter (Register 63, No.
							 17).
2. Amendment filed 12-17-85; effective thirtieth day thereafter
							 (Register 85, No. 51).
Note: Authority cited: Sections
								208 and
								1704,
								Health and Safety Code. Reference: Section
								1704,
								Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 5 - Sanitation (Environmental) › Subchapter 2 - Foods and Drugs › Group 1 - RULES AND REGULATIONS › Article 2 - DRUGS AND DEVICES REGULATIONS › Drugs and Devices › Section 10400.5 - Mucorhicin Agent for Treatment of Cancer

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(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.
1. New
							 section filed 10-3-63; effective thirtieth day thereafter (Register 63, No.
							 17).
2. Amendment filed 12-17-85; effective thirtieth day thereafter
							 (Register 85, No. 51).
Note: Authority cited: Sections
								208 and
								1704,
								Health and Safety Code. Reference: Section
								1704,
								Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 5 - Sanitation (Environmental) › Subchapter 2 - Foods and Drugs › Group 1 - RULES AND REGULATIONS › Article 2 - DRUGS AND DEVICES REGULATIONS › Drugs and Devices › Section 10400.6 - Anthrone Test for Diagnosis of Cancer

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(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.
1. New
							 section filed 7-28-65; effective thirtieth day thereafter (Register 65, No.
							 13).
2. Amendment filed 12-17-85; effective thirtieth day thereafter
							 (Register 85, No. 51).
Note: Authority cited: Sections
								208 and
								1704,
								Health and Safety Code. Reference: Section
								1704,
								Health and Safety Code.