California Livestock Drug Qualified Individual and Licensed Retailer Resources

Certain antimicrobial restricted livestock drugs changed status on January 1, 2018 to require a prescription for purchase and use in California. California prescription drugs (CA Rx drug) may only be dispensed by a Qualified Individual (QI) or pharmacist if a licensed retailer wants to sell CA Rx drugs.

A QI can only dispense a drug if the prescription matches the FDA approved label exactly.

 The QI cannot break a drug down into individual units or dispense individual volumes/quantity of drug.  A QI can only dispense prescription products in their original packaging. The quantity or volume to be dispensed does not necessarily have to be the exact volume that is required for the animal(s) treatment.  Often times, the quantity of volume that will be written for and dispensed will be more than is required for the treatment plan. Additionally, the current treatment plan does not necessarily have to dictate the amount of drug dispensed.  If the veterinarian anticipates the course will need to be repeated, etc., a larger volume/quantity can be dispensed as long as the quantity indicated corresponds to the quantity of product available on the market to be dispensed. The QI can dispense the amount indicated on the prescription as long as it corresponds to a marketed product. Additionally, the drug can be dispensed in multiple packages if the total quantity requested is larger then the volume of individual packages. For further explanation and examples click here.

In order for a licensed retailer to sell CA Rx drugs, a consulting pharmacist or staff pharmacist will need to be employed. A pharmacist is needed in order to create store-specific written operating procedures as defined in Chapter 4, Section 5012 of the California Food and Agriculture code. Consulting and staff pharmacists can also aid in answering prescription questions and filling prescriptions that a QI is legally unable to fill.

Please email AUS_Regulations@cdfa.ca.gov for additional information and to register for a QI training session.

Prescription requirements

The following highlighted portions need to be specified on a prescription if a QI is to dispense the CA Rx Drug:

Drug brand/ Trade name:

The drug brand or trade name is the name the drug is marketed as.

Examples:
  • Tylan®50
  • Supra-Sulfa® III
  • ToDAY®

Active ingredient:

The active ingredient is the ingredient in the drug that is biologically active.

Some active ingredients are available in different salt forms. It is important to verify the correct active ingredient is dispensed as this can alter directions or the withdrawal time.

Examples:
  • Oxytetracyline hydrochloride vs. oxytetracycline dehydrate
  • Penicillin g procaine vs. penicillin g benzathine.
    • Note: There is a product that contains BOTH penicillin g procaine and penicillin g benzathine.

Examples of active ingredients included in California Senate Bill 27 (SB 27):
  • Penicillin
  • Oxytetracycline
  • Neomycin
  • Spectinomycin
  • Tylosin
  • Cephapirin
  • Sulfadimethoxine
  • Lincomycin
  • Sulfamethazine
**Please note this list is up to date as of 1/3/2019. Please consult the CDFA link below for the current list of active ingredients included in SB 27.

Quantity of Drug to be Dispensed

The Volume or number of units sold in the package.

The quantity of the drug to be dispensed must be specified on the prescription.

Dose

The dose on the prescription needs to be written exactly as that on the drug label. If it does not match the label, the QI cannot dispense the drug and the prescription needs to be sent back to the client or prescribing veterinarian.

If the prescription does not match the drug label, the client or QI can call the veterinarian of record and have the veterinarian resubmit a corrected version via fax, email or in person. The correction cannot be submitted verbally to a QI. If the consulting or staff pharmacist is on the premise, they can take a verbal order or correction. 

Withdrawal Time

The amount of time it takes for the drug administered to deplete/leave the animals body or edible products. The withdrawal time can be affected by the salt forms of an active ingredient or if the drug is improperly stored and/or administered.

Drug Strength/ Concentration

The amount of drug in dosage form or a unit of the dosage form.

Examples:
  • 200mg oxytetracycline/mL
  • 15 g sulfadimethoxine/ bolus
  • 300,000IU penicillin activity/ mL

Indication

What the drug is being used to treat.

Examples of an indication:
  • Use for the treatment of bacterial pneumonia (shipping fever) caused by Pasteurella multocida.
  • Foot rot
  • Anaplasmosis

Treatment Duration/ Total Number of Doses

Treatment duration is the length of time that the medication will be administered for. This can be written as number of doses or number of days.

Route of Administration

The way in which the dosage form is given to the animal.

Frequency of Administration

Frequency of administration is the frequency or how often the drug is administered to the animal.
  • qd= Once daily
  • SID= Once daily
  • BID = Twice daily
  • TID = Three times daily, or every 6 hour
  • QID= 4 times daily or every 6 hours.

Refills

If the number of refills is not stated on the prescription, it is common practice to assume no refills can be dispensed. It is up to the licensed retailer and contract/staff pharmacist to decide on a protocol to address this assumption.

If NR is selected, the prescription can only be dispensed once with no refills.

If PRN is selected, the prescription can be refilled an unlimited amount of times within the 6 month window of the prescriptions issue date.

Species and Production Class

Certain drugs are labeled for specific animal species and specific production classes. In order for a QI to dispense a CA Rx Drug, the species and production class (if applicable) of the animal treated must be specified on the prescription and match the corresponding drug label.

Other abbreviations


q = every
h or hr = hours
NR = No additional refills of prescription allowed
PRN= refill prescription as needed.

Resources

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Retailer requirements to sell CA Rx Drugs
aus_sellingcarx.pdf
File Size: 467 kb
File Type: pdf
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Qualified Individual requirements
aus_qirequirement.pdf
File Size: 56 kb
File Type: pdf
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A quick reference sheet containing useful information for a Qualified Individual dispensing CA Rx drugs.
farad_qi_fact_sheet.pdf
File Size: 456 kb
File Type: pdf
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A form that can be used to determine if a prescription can be filled by a Qualified Individual.
prescription_verification_checklist_2_.pdf
File Size: 346 kb
File Type: pdf
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A form that can be sent to a veterinarian to aid in obtaining a correct prescription.
unable_to_dispense_rx.pdf
File Size: 203 kb
File Type: pdf
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Restricted livestock drug retailer frequently asked questions (FAQs)
aus_rldretailerfaqs.pdf
File Size: 48 kb
File Type: pdf
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FARAD training powerpoint presented at a Qualified Individual training session - December 2018.
farad_qi_training_ppt.pdf
File Size: 3268 kb
File Type: pdf
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California prescription drug sales log for licensed retailers.
ca_rx.pdf
File Size: 36 kb
File Type: pdf
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Restricted livestock drug sales log for licensed retailers.
rld.pdf
File Size: 113 kb
File Type: pdf
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Restricted livestock drug & California prescription drug sales log for licensed retailers.
rld___ca_rx.pdf
File Size: 37 kb
File Type: pdf
Download File