Section 111375 Of Article 3. Misbranded Drugs Or Devices From California Health And Safety Code >> Division 104. >> Part 5. >> Chapter 6. >> Article 3.
111375
. Any drug or device is misbranded unless its labeling bears
all of the following information:
(a) Adequate directions for use.
(b) Such adequate warnings against use in pathological conditions
or by children where its use may be dangerous to health.
(c) Adequate warning against unsafe dosage or methods or duration
of administration or application.
Warnings shall be in a manner and form as are necessary for the
protection of users.
If the department determines that any requirement of subdivision
(a), as applied to any drug or device, is not necessary for the
protection of the public health, the department may adopt regulations
exempting the drug or device from these requirements.
Any drug or device exempted under Section 502(f) of the federal
act (21 U.S.C. Sec. 352(f)) is exempt from the requirement of this
section. The department, however, may adopt any regulation including
a drug or device within, or excluding a drug or device from the
requirements of this section, whether or not the inclusion or
exclusion of the drug or device is in accord with the federal act.