Update on Prescription Laws For Food Animal Veterinarians
The CVMA Agriculture Committee has reviewed current prescription laws and procedures that pertain to food animals and developed a system for VFADR complaint reporting. The CVMA connected with inspectors at the Board of Pharmacy to illuminate problems pertaining to VFADRs. As a result, Board of Pharmacy inspectors visited dairies, closely examined VFADRs, and issued citations and fines for various VFADR violations of pharmacy law. In addition, representatives from the Board of Pharmacy met with members of the CVMA Agriculture committee to form a strategic plan to address current issues.
Planning outcomes to date include:
- Refining the Board of Pharmacy complaint form
- Educating food animal practitioners on key issues and laws
- Encouraging food animal practitioners to report VFADR violations
- Including a link to Board of Pharmacy complaint form from the CVMA web site
Notes on filing complaints:
- All complaints are confidential
- All complaints will be investigates by Board of Pharmacy inspectors
- The inspection process can take 6-12 months depending on the nature of the complaints
Resources Available for Veterinarians
Definition of Veterinary Food Animal Drug Retailers
(a) B&P Code 4041: “Veterinary food-animal drug retailer” is an area, place, or premises, other than a pharmacy, that holds a valid license from the Board of Pharmacy of the State of California as a wholesaler and, in and from which veterinary drugs for food-producing animals are dispensed pursuant to a prescription from a licensed veterinarian. “Veterinary food-animal retailer” includes, but is not limited to, any area, place, or premises described in a permit issued by the board wherein veterinary food-animal drugs, as defined in Section 4042, are stored, possessed, or repackaged, and from which veterinary drugs are furnished, sold, or dispensed at retail pursuant to a prescription from a licensed veterinarian.
Visit the California Board of Pharmacy web site to see current licenses of Designated Representatives, VFADRs, and Wholesalers.
KEY SECTIONS OF LAW:
- Business & Professions Code, Chapter 11, Division 2, Article 2, Section 4826 defines the practice of veterinary medicine
- California Code of Regulations, Title 16, Division 17, Article 2, Section 1717 dictates how prescriptions are transcribed, filled, and transferred between pharmacies
- California Code of Regulations, Title 16, Division 17, Article 10, Section 1780.1 details minimum standards for VFADRs, including the requirement that only a licensee may receive an oral prescription and expanded invoice requirements
- Business & Professions Code, Chapter 9, Division 2, Article 3, Section 4053 dictates the oversight of a VFADR by a pharmacist or designated representative
- Business & Professions Code, Chapter 9, Division 2, Article 4, Section 4073 contains the “do not substitute” language
- Business & Professions Code, Chapter 9, Division 2, Article 4, Section 4076-77, 4199 dictates how prescription drugs are labeled
- Business & Professions Code, Chapter 9, Division 2, Article 2, Sections 4041-4043 define VFADR, Veterinary Food Animal Drugs, and Wholesaler
- Business & Professions Code, Chapter 9, Division 2, Article 15, Sections 4196-4199 details the VFADR licensing requirements and procedures for labeling
FDA and the Veterinarian, 2005, p. 12-13 “Regardless of the cause, it is FDA’s policy to hold responsible any individual in the production and marketing chain who can be shown to have caused (by an act of commission or omission) illegal residues or other contaminants in edible animal products .”…“If a veterinarian prescribes, dispenses, or treats an animal(s) with a drug which results in the occurrence of an illegal drug residue in edible products from the treated animal, the veterinarian may be held responsible for having caused a violation of law.”
METHODS OF EDUCATION
- CDFA mailing list of Accredited Veterinarians
- CVMA Website
- California Veterinarian
- Bovine Practitioner
VETERINARY FOOD ANIMAL DRUG RETAILER ACT
With the passage of the Veterinary Food Animal Drug Retailer Act (AB 611) in 1998, the handling of prescription and extra-label drugs changed for the food animal veterinarian. The commonly used drug authorization form was replaced by a veterinary prescription. This change benefited the veterinarian greatly with little effect on the producer.
A prescription is written by the veterinarian to the producer instructing him as to prescription products to be purchased and includes pertinent information regarding dose and duration of treatments, including proper withdrawal times. It is the producer’s responsibility to fill the prescription and be responsible for payment.
The veterinarian has professional responsibility for the content of the prescription but is in no way financially liable.
By writing a prescription, it becomes the responsibility of the licensed Veterinary Food Animal Drug Retailer (VFADR) to print and affix labels to products and to furnish a properly labeled product to the producer.
There is no standard size for a prescription. A prescription form may be as small or as large as the veterinarian wishes. It is up to the veterinarian to find a size that fits his/her practice. Sample prescriptions follow this overview.
Prescription forms may be for single or multiple drugs. There is a procedure VFADRs shall follow if a producer wishes to purchase individual items from different VFADRs. It is not the veterinarian’s responsibility (California Code of Regulations, Section 1717(e)). Remember, the prescription is written to the producer, and it is his/her responsibility to have it filled. A veterinarian should not provide multiple prescriptions for the same product for different VFADRs.
If a veterinarian wishes to dispense product to his/her client, a written prescription is not needed. However, a veterinarian cannot force a client to buy a prescription product from himself/herself. A client must be given a written prescription upon request for a drug prescribed by the veterinarian. A veterinarian may not fill a prescription from a colleague unless he/she has a VFADR license.
Oral prescriptions can only be given to a licensed pharmacist or Designated Representative (formerly “exemptee”) in the VFADR business. A written copy of the oral prescription shall be sent or electronically transmitted to the prescribing veterinarian within 72 hours (California Code of Regulations, Section 1780.1(d)). Due to lack of compliance with these regulations on oral prescriptions, it is recommended to only give or fax written prescriptions.
VFADRs are required to furnish a copy of the record of shipment or “expanded invoice” to the prescribing veterinarian. The expanded invoice copy must include prescription drug names, quantity shipped, manufacturer’s name and lot number, date of shipment, and name of pharmacist or designated representative responsible for distribution. Commonly these are furnished to prescribing veterinarians monthly.
The content of a prescription is standard and regulated by the California Board of Pharmacy and the Veterinary Medical Board. The California Code of Regulations, Section 2032.2 (a) requires that the following must be included:
- The name, signature, address and telephone number of the prescribing veterinarian.
- The veterinarians license number and his or her federal registry (DEA) number if a controlled substance is prescribed.
- The name and address of the client.
- The species and name, number or other identifying information for the animal.
- Because of Section 7, Item 15r of the Guide “A” Pasteurized Milk Ordinance, prescriptions for dairy animals must include the class of animal being treated. The FDA’s Center for Veterinary Medicine Guideline 45 defines the following classes of cattle:
- lactating dairy cattle – an adult female dairy cow producing milk at the time of drug administration
- dry cows – an adult female dairy cow in a non-lactating, i.e. “dry”, state, at the time of drug administration
- heifers – female dairy cattle under 20 months of age
- beef cattle – beef cattle including dairy breed steers and bulls
- veal calves – bob veal and fancy veal calves
- calves – beef and dairy calves excluding veal calves
Note: RX Superscription (Latin for “take thou of”) consists of items 5 and 6 below.
5. The name, strength, and quantity of the drug(s) – (Inscription).
- The inscription should be precise. The generic name can be used unless the prescriber wishes a specific product used (Banamine® vs. generic flunixin meglumine).
- If a veterinarian wishes to use the brand name product instead of a generic, the words DO NOT SUBSTITUTE, along with a checked box and the veterinarian’s initials must be present on the prescription (Business and Professions Code Section 4073).
- The strength and size also needs to be precise (100mg/ml, 250 ml). The amount should be stated so there will be no question as to quantity prescribed. “One case” of oxytocin is vague, and the number of bottles should be written instead. Mastitis tubes may be prescribed as 144 syringes, 12 dozen syringes or as one gross.
- The inscription should be written as clearly as possible. If there is one strength and size of the drug available, only the name and amount need to be written. For example, the inscription for 10 vials of Cystorelin® would read Cystorelin #10. If there are various strengths and/or sizes of the product, the inscription must be specific. A prescription for one 250 ml flunixin meglumine 50 mg/ml would read 50 mg/ml flunixin meglumine 250ml #1.
- All inscriptions and subscriptions should be written in plain English where possible to avoid confusion in transcription at the Retailer level.
6. Directions for use, including, if applicable, withdrawal time and cautionary statements. (Subscription)
- The subscription will vary depending on the drug prescribed. A restricted product being used according to label directions and indications (Cystorelin®) can be subscribed by writing, “Use as directed.” An extra-label drug (penicillin G procaine) requires the dose, duration, withdrawals, and cautionary statements to be written.
- Indications for use can be as general or specific as the prescriber wishes. Indications for Polyflex® might be “for infections,” while those for Baytril® 100 must be more specific and should include production class and cautionary statements.
7. Date of issue.
- According to the California Code of Regulations, Section 1780.1(g)(2), prescriptions cannot be refilled by a VFADR for more than six months after the original prescription date.
8. The number of refills.
- According to the California Code of Regulations, Section 1780.1(g)(1):
- if no refills are indicated on the initial prescription, no refills may be dispensed, and a new prescription must be written
- although many veterinarians feel that writing prescriptions for zero refills simplifies accountability and accuracy of amounts sold, this practice is not recommended unless one is prepared to write a new prescription every time a quantity of prescription drug is ordered
- if you are concerned about accuracy of amounts sold with your prescriptions, please report prescription over-filling to the Board of Pharmacy (see below)
- According to the California Code of Regulations, Section 1780.1(j):
- “If a retailer is unable at any one time to fill the full quantity of drugs prescribed, the retailer may partially ship a portion so long as the full quantity is shipped within 30 days.”
- “If a retailer is unable to dispense the full quantity prescribed within 30 days, a new veterinarian’s prescription is required to dispense the remainder of the drugs originally prescribed.”
§ If an unused refill is available on the prescription, a refill may be used to dispense the remainder of the drugs originally prescribed.
Veterinarians that have complaints about how VFADRs handle, fill, or label their prescriptions should report violations to the California Board of Pharmacy. The Board of Pharmacy regulates veterinary drug wholesalers and retailers in California. Their website for complaints is http://www.pharmacy.ca.gov/consumers/complaint_info.shtml
SAMPLE PRESCRIPTIONS FOLLOW
HAPPY COW VETERINARY CLINIC
John Doe, DVM License # XXXXX
Cowtown, CA XXXXX
Drug Prescription for Joe Smith Dairy, Inc. 1234 Smith Road, City, CA XXXXX
Prescription good for quantity indicated and expires on 6/30/2007
Refill 5 times
RX#QW001: Cystorelin (gonadorelin diacetate, 50 mcg/ml) 10 ml # 20
sig: For treatment of cystic ovarian disease or the synchronization of estrus * in lactating and non lactating dairy cattle. Give 2cc IM. Zero milk and meat withdrawal.
RX#QW002: dexamethasone (2mg/ml) 100ml # 4
sig: Use to decrease swelling and combat shock. For treatment of coli mastitis, ketosis, and allergic reactions in cattle. Give 10-20 * cc per cow IM or IV daily – limit to 3 consecutive treatments. Zero milk and meat withdrawal. Caution: Do not administer to pregnant animals – may cause abortion.
RX#QW003: dinoprost tromethamine (5mg/ml) 30 ml # 20
sig: For induction of estrus, estrus synchronization, and treatment of pyometra in lactating and non lactating dairy cattle. Can cause abortion, do not use in pregnant animals. Do not allow pregnant women or asthmatics to handle. Administer 5cc intramuscularly. Zero meat and milk withhold.
RX#QW004: Excenel (ceftiofur hydrochloride, 50 mg/ml) 100ml # 5
sig: For the treatment of meteritis, pneumonia, and footrot in cattle, including lactating dairy. Use 1-2 cc IM or SQ per 100 lbs. daily for 3-5 days. Withhold milk zero days and meat 2 days.
RX#QW005: flunixin meglumine (50mg/ml) 250 ml bottle # 5
sig: For treatment of toxic shock and swelling associated with mastitis or pneumonia in cattle. Give 1cc per 100 lbs IV. Withhold milk 36 hours and meat 4 days.
RX#QW006: Multimin-cattle 500 ml # 5
sig: Follow label directions. †
RX#QW007: Quartermaster (10ml syringes) pail of 144 # 3
sig: Follow label directions. †
Note to pharmacist or Veterinary Food Animal Drug retailer: generic compounds prescribed may be filled with any brand according to your professional judgment. The veterinarian expects your choice to comply with all state and federal regulations pertaining to veterinary drug dispensing. Labeling procedures must meet current standards of all federal and state agencies with jurisdiction over food animal prescription products in California. ‡
Date Prescribed: 1/1/2007
IMPORTANT FEATURES DEMONSTRATED BY THIS PRESCRIPTION:
Multiple item prescriptions are allowed.
The Board of Pharmacy requires that each item have a unique number; either the veterinarian assigns numbers at the time of prescribing or the pharmacy exemptee assigns numbers upon receipt.
Veterinarians are required to keep a record of drugs prescribed, not necessarily a facsimile. It behooves the practitioner, however, to keep exact copies in the event of a milk or meat residue.
* Extra label directions are required for approved products used in an extra label fashion or at an extra label dose.
† Manufacturer’s directions are often sufficient and directions for use can simply state “follow label directions”.
‡ Dosage, indications for use and withdrawal times are all subject to change. A caveat placing at least some of the responsibility on the pharmacy exemptee is wise.
© 2017 California Veterinary Medical Association