Article 4. Registration of California Food And Agricultural Code >> Division 7. >> Chapter 4. >> Article 4.

A person shall not sell any livestock drug in this state prior to receipt of a registration certificate pursuant to this chapter.

The manufacturer of any livestock drug shall apply to the director for registration of the livestock drug.

The application shall be in a form which is supplied by the director. It shall show all of the following:
  (a) The name of the applicant and the address of his principal place of business.
  (b) The name, brand, or trademark under which the livestock drug is to be sold.
  (c) The minimum net contents of each size and type of container in which the livestock drug is to be sold at retail.
  (d) The name of each active drug ingredient and the quantity or proportion of each such ingredient.
  (e) A statement of each purpose for which the livestock drug is to be used.
  (f) A statement of the form in which the livestock drug is to be administered, the method of administration, and, if the method of administration involves the use of any special device which is supplied with such drug, a description of such device.
  (g) A statement of the amount and frequency of the dosage which is to be recommended.
  (h) Such other information and data as the director may require.

The application shall also contain a detailed description, or be accompanied by a copy, of the label of each type and size of container in which the livestock drug is be sold at retail.

The label shall contain all of the following:
  (a) The name, brand, or trademark of the livestock drug.
  (b) The name of the applicant and his principal address.
  (c) The minimum net contents of the container.
  (d) A statement of the disease or ailments of livestock which it is claimed that the livestock drug will alleviate or cure.
  (e) Adequate instructions as to use and administration and adequate warnings against improper use and administration of the livestock drug, including adequate withdrawal periods and product disposal times to prevent any dangerous drug residues in products produced by livestock for human consumption.
  (f) The name and amount of each active drug ingredient.
  (g) A statement which clearly indicates that the product is not for human use.
  (h) If the livestock drug is a restricted drug, the words "restricted drug, use only as directed" in conspicuous letters.
  (i) Such other information as the director may require to ensure proper use to safeguard the health of animals and humans who consume products from such animals.

If it is proposed that any instructions for use, other than those on the label, shall accompany containers of the livestock drug which are sold at retail, a copy of such instructions shall accompany the application for registration of the livestock drug.

The director shall examine and consider the application together with all material, data, and information which accompanies it.

The director shall refuse to register a livestock drug if he finds any of the following is true of the drug:
  (a) It is of little or no value for the purpose for which it is intended to be used.
  (b) It is dangerous to the health of livestock if used in accordance with the instructions.
  (c) The instructions for use do not contain adequate warnings against use in those conditions, whether pathological or normal, under which its use may be dangerous to the health of livestock or humans who consume products from such livestock, or against unsafe dosage, unsafe duration of use, or unsafe methods of administration.
  (d) If the application and the accompanying material, data, and information do not comply with the requirements of this chapter or are insufficient to permit the director to make the determinations which are required by this section.

If the livestock drug is a restricted drug, the director shall also refuse registration if he finds that the instructions for use do not contain adequate and satisfactory directions as to the methods of handling, caring for, holding, or otherwise managing the livestock to which the drug is administered so as to eliminate any danger to the health of any person who might consume food products which are derived from such livestock.

The registration of a livestock drug includes all of the following:
  (a) Registration of the drug and its ingredients.
  (b) Registration of the label.
  (c) Registration of the instructions for use.
  (d) Registration of the special device, if any, for the administration of the livestock drug.

(a) The fee for a two-year registration certificate for a livestock drug is one hundred eighty dollars ($180). The certificate period shall commence beginning January 1 of each even-numbered year and expire on December 31 of the next odd-numbered year.
  (b) The fee for a registration certificate submitted during an odd-numbered year shall be ninety dollars ($90), and the certificate shall remain in effect until December 31 of that year.
  (c) The fee shall accompany the application for registration. The fee is not refundable if the registration is refused.

If registration is granted, the original fee covers the registration for the remainder of the then current calendar year in which registration is granted.

The fee for application for renewal of registration is one hundred eighty dollars ($180) for a two-year period. It is payable on or before January 31st of each year. If it is not so paid, a penalty of fifty dollars ($50) shall be added to the fee.

The director may quarantine and remove from sale any livestock drug which is not registered pursuant to this chapter or any livestock drug which does not conform in all respects with its registration.

The director shall have access at all reasonable hours to all premises which are used in the manufacture, sale, or storage of any livestock drug, or where livestock drugs are mixed in feed for administering to livestock. He may take samples and make such other investigations as are necessary to carry out this chapter and the regulations which are adopted pursuant to it.

The director may revoke the registration of any livestock drug if he finds, from representative samples, that the drug as offered for sale fails to conform to its registration. The director may allow reasonable tolerances within which such samples may vary from the registration.