Section 10377 - Definitions(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.(j) Transfusion means a use of blood or blood components in which the blood or blood components are administered into a vein of a human being for treatment of disease, including physical injury.Cal. Code Regs. Tit. 17, § 10377
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. Editorial correction of printing error in subsection (e) (Register 93, No. 28).
5. Certificate of Compliance as to 1-20-93 order including amendment of subsection (d) 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 26209, 26685, 26686 and 26688, Health and Safety Code.
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. Editorial correction of printing error in subsection (e) (Register 93, No. 28).
5. Certificate of Compliance as to 1-20-93 order including amendment of subsection (d) transmitted to OAL 5-26-93 and filed 7-8-93 (Register 93, No. 28).