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§ 10377.1. Qualifications.


Barclays Official California Code of Regulations Currentness
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 (Refs & Annos)
17 CCR § 10377.1
§ 10377.1. Qualifications.
(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 s 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.
(b) As used in subsection (a), “conviction” includes a plea, verdict, or finding of guilt regardless of whether sentence has been imposed, but does not include:
(1) any conviction for an offense specified in subdivision (a) or (b) of Health and Safety Code Section 11361.5 which became final more than two years prior to the date of the license application, or
(2) any conviction under Health and Safety Code Section 11557 or its successor Section 11366 when that conviction was stipulated or designated to be a lesser included offense of the offense of possession of marijuana;
(c) The Department may deny a license to a license applicant if it determines that the granting of such a license would not be in the public interest, based on factors which are substantially or rationally related to protecting the public from adulterated or misbranded human prescription drugs.
Note: Authority cited: Sections 102, 208, 26202 and 26209, Health and Safety Code. Reference: Sections 26611, 26612, 26689 and 26691, 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 (a)(6) (Register 93, No. 28).
5. Certificate of Compliance as to 1-20-93 order including new subsections (b)-(b)(2) and subsection relettering, transmitted to OAL 5-26-93 and filed 7-8-93 (Register 93, No. 28).
This database is current through 9/10/21 Register 2021, No. 37.
17 CCR § 10377.1, 17 CA ADC § 10377.1
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