2b Packaging And Labelling When Dispensing Animal Remedies

Policy

Veterinarians dispensing Prescription Animal Remedies (PARs) and products over the counter (OTC) must package and label these products to meet legal requirements and also the ethical requirement to protect the animal and client from incorrect usage, and others, especially young children, from unintended access.

Explanation

Products are packaged for convenience of handling and administration, and labelled to indicate the correct application and, if appropriate, give safety instructions or warnings.  Correct packaging and labelling also discourages inadvertent access and misuse.

The legal requirements for packaging and labelling PARs and OTCs are limited, but the ethical duty to meet reasonable standards is part of professional responsibility, enforceable through the profession's disciplinary process.

However, veterinarians dispensing prescription medicines must meet the same legal requirements as medical practitioners and pharmacists, which are considerably more specific.

In the event of serious harm to humans as a result of failure to meet professional standards for packaging and labelling of a product dispensed, the veterinarian concerned could face criminal charges as well as professional misconduct action.

For this reason all dispensed products must be packaged and labelled in such a way that accidental poisoning of humans should not occur.  If it does, the label must provide the information needed by medical personnel to immediately identify the active and the likely dose involved, and if necessary contact the practice and the prescribing veterinarian for further information. This is in addition to providing concise instructions for the client for whose animal it was prescribed.

Guidelines

A. Packaging

1. Tablets/Capsules (solid products for oral administration)
   1. Unopened manufacturer’s/distributor’s package
      Would normally meet safety requirements.  Ensure practice label does not obscure essential information on manufacturer’s label.
   2. Individual tablets/capsules
      
      1. Foil wrap/blister pack presentation ‑ legally regarded as safety containers.
         Resealable mini‑grip/zip lock envelopes may be used.  Child resistant safety containers (CRSCs) should be available if requested by client.
      2. Loose tablets/capsules should be packed in a resealable CRSC.
         Note:  Legal Requirements
         The Medicines Regulations specifically require use of approved child resistant safety containers for the following classes of medicines:
      • Barbiturates
      • Phenothiazine, and derivatives of phenothiazine and their salts, except dimethothiazine, methdilozine, promethazine, and trimeprazine, and their salts and molecular compounds
      • Tricyclic, tetracyclic, and analogous antidepressants

        In the case of prescription medicines, with few specific exceptions, a safety container must be used when dispensing loose tablets, capsules or other solid substances for oral administration.

        (NB: Discretion may be used when the client specifically requests that a CRSC not be used because physical disability makes these difficult to open)

3. Oral Pastes
   Dispensed in manufacturers' container

2. Ointments/Creams/Lotions (for topical use)
   Manufacturer’s pack would normally meet safety requirements.  If the pack is too small to accept standard label with all required information, use a small label identifying practice, client, patient, instructions for use, date and the instruction “FOR ANIMAL USE ONLY” Dispense in resealable pack containing full labelling details.  Ensure practice label does not obscure essential information on manufacturer’s label.(e.g. “for topical use only”)., or if this is not feasible, that the information is incorporated in the practice label.  Longer labels may be applied in "flag" format.
3. Liquids (for internal or external use)
   1. Manufacturer’s Container
      Would normally meet safety requirements.  Ensure practice label does not obscure essential information on manufacturer’s label.
   2. Repackaged by practice
      Ensure that the pack is suitable for safe containment of the contents and the practice label incorporates all necessary information (e.g. warnings) present on the  manufacturer's container.
      (Note: The legal and ethical requirements for repackaging must be met.)
4. Injectable products (for owner administration by hypodermic syringe)
   1. Manufacturer’s pack
      Would normally meet safety requirements.  Ensure practice label does not obscure essential information on manufacturer’s label.
   2. Pre-loaded syringe (prepared by dispensing practice)
      Ensure that the pack is suitable for safe containment of the contents, especially with regard to needle protection and accidental product leakage, and the practice label incorporates all necessary information (e.g. warnings) present on the  manufacturer's container. Syringe and needle should be capped.
      (Note: The legal and ethical requirements for repackaging by a veterinarian must be met.)
5. Bags of medication
   It is recommended that when medication has been prescribed or dispensed in large bags that cannot be easily resealed (such as in-feed medication), the veterinarian, when visiting the farm, inspects the storage facilities to ensure the products are safely and appropriately stored.

B. Labelling

The dispensed container should be labelled with the following information, legibly and indelibly printed:

1. Practice dispensing label
   1. Practice name, address and 24-hour telephone contact number(s). Name of prescribing veterinarian in multi vet practice (initials are adequate)
   2. Client name, patient name (where applicable) and species (may be coded)     
   3. Client address (may be coded)    
   4. Purpose for which drug prescribed (if relevant)
   5. Product/drug name and strength
   6. Number of tablets/capsules, or volume of liquid dispensed
   7. Date dispensed
   8. Directions for use ‑ dose, frequency and method
   9. Essential warnings or relevant additional information (e.g. for external use only, for oral administration, give with food, special storage requirements etc)
      
      1. The statement "FOR ANIMAL USE ONLY" in bold print, or similar
   10. The statement "Keep out of reach of children"
   11. Products for use in production animals must have the registered withholding time on the label
2. Labelling small packages
   Small tubes, bottles, syringes etc should not be dispensed without some identifying label, even though the bulk of the information is incorporated either on a larger outer container or an attached practice dispensing label, in case the product and the outer become separated and essential information is lost.

   The small label should identify practice, client, patient, product name, instructions for use, date dispensed and the instruction "FOR ANIMAL USE ONLY".  Dispense in resealable pack containing full labelling details.

Definitions

Essential warnings are those required by law for Poisons/Dangerous Poisons/Deadly Poisons (as per Toxic Substances Act), and some harmful substances.  The warnings are clearly indicated on the manufacturer’s/distributor’s package.

Auxiliary warnings are discretionary, and mostly to ensure correct route of administration (eg “For external use only”, “Not to be taken”) or conditions of storage (eg light, temperature, humidity).

Action advice is usually provided by the warning labels for Deadly Poisons, Dangerous Poisons and some standard Poisons, and would not normally be required for practice labels on PARs.

Legal and ethical requirements for repackaging

The veterinarian is responsible for ensuring safe working practices by staff.  These include adequate training, suitable work areas, and suitable procedures with appropriate supervision.  Standards of cleanliness and care with empty containers and spills, and human safeguards, must be appropriate to the level of risk inherent in the product.  The manufacturer’s advice must be sought where appropriate.

Local authorities must be consulted before any potentially hazardous chemical is allowed to pass into a waste area, including waterways, or before containers which contained chemicals are disposed of in local authority tips.

"Keep out of the reach of children"

Veterinary and human medicines must be kept where they are not easily accessible to children. The definition of a child is not precise; it assumes someone who is still dependent on their parents. 

Child resistant safety containers (CRSCs)

Medicines Regulations 1984/143, as amended by R.2 of 1994 / 299.

Regulation 2 ‑ Interpretation

"Safety Container" means a container, whether or not part of a strip of containers, that:

1. encloses a single tablet or other single item of a medicine that is a solid or a class of medicines that are solids (including a medicine or class of medicine in powder form); and
2. is made of aluminium foil or laminated plastic, or such other material as may be approved by the Director General in relation to the packaging of any solid medicine to which regulation 37 of these regulations applies, either by notice in the Gazette or in writing addressed to a particular manufacturer, packer, importer or seller of medicines; and
3. is reasonably resistant to attempts by young children to open it.

Regulation 37 ‑ Safety Containers

No person shall sell any tablet, or other single item in solid form that is intended to be taken orally, being or comprising a medicine belonging to a class of medicines to which this regulation applies, unless the tablet or item is enclosed in a safety container.

A CRSC must have been officially designated as such by the Director General of Health.  Other than approved material for strip packaging, the authorities do not define CRSCs; rather each container is treated on its merits.  Suppliers will be able to specify which of their containers have been approved.

Pharmacists supply all loose tablets or capsules in CRSCs, unless specifically requested, even for products not designated under Regulation 3

Policy Files: 

2b - Packaging & Labelling - 16May03.pdf