Unit Dose Label Definition

With manual single doses, this is not always possible, and sometimes the drugs are put in stock and are then dosed as a unit dose. Although an ampoule must be diluted in the infirmary to be considered a single dose process, it is usually referred to as a unit dose and also, when the pharmacy turns into units (blisters or ampoules) for delivery to the infirmary, we call this process unit dose. Due to the general inconsistency in the labelling of single-dose containers due to inconsistent interpretations of regulations or a lack of awareness of unit dose labelling requirements, we are publishing this Compliance Policy Guide (CPG). There are also semi-automatic unit dosing machines and equipment to perform the entire process automatically, without the operator being constantly present in all cycles. The label of the actual dose container shall contain all of the following information (except point 9). Solid and liquid oral dosage forms in standard-dose containers are considered to be mislabelled in accordance with section 502 of the Act if they deviate from the attached list of requirements. Since unit dosage forms are primarily intended for institutional use and not for sale to the general public, we will not require the precautionary statements described in 21 CFR Part 369 or the statements described in Section 6.b. (Sections I and II) of Exhibit A to appear on the label; However, this information must be included elsewhere on the label. Pending the revision of the rules, the attached document outlines the labelling requirements for solid and liquid oral dosage forms packaged in single-dose containers. The requirements apply to all companies that package drugs in dosed containers. In addition to all the above information (except point 9), the outer packaging from which the container intended for the distribution of the single dose is dispensed shall contain the following information: This procedure is usually carried out immediately after receipt of the drug in the hospital and before admission to closed stock (inventory 1). Single dose processes with automatic machines are the standard procedure.

It also reduces the working time of the care team through unit doses on each floor, reducing waste. NOTE: A company cannot apply for an exemption on the basis that the label is too small to contain all the mandatory information if all available space is not used or if the size of the label can be slightly increased, or if the font size on the label can be slightly reduced without compromising the legibility of the information. Other forms of unit doses, e.g. topical ointments/creams, ophthalmology, etc., are not included in this document. They will be taken into account at a later stage if circumstances warrant. No action will be taken against a single-dose repackaging company, including joint services, or pharmaceutical products in single-dose containers that meet all other conditions of the FDA`s repackaging requirements, solely on the basis of the repackaging company`s failure to conduct stability studies to support the expiry dates used, provided that: This GIC does not include a unit of the „use” packaging, which is defined as the method of producing a legendary drug in an original container. sealed and labelled, pre-labelled by the manufacturer and containing sufficient medication for normal treatment. (Source: Proceedings Unit of Use Packaging Conference, January 24-26, 1979). But its use is not yet widespread in all countries; Even in Europe, there are still several countries that send drugs to stations in boxes that are uniformly dosed at the time of use. In recent years, the pharmaceutical industry has responded to an increased demand for packaged drugs for unit dose delivery, i.e.

the administration of a single dose of a drug to the patient at the time of administration for institutional use, for example in hospitals. The drug is dispensed in a unit dose container – a single-use container intended to contain a quantity of drug intended to be administered (other than parenterally) in a single dose directly from the container and typically used in a hospital dose system. The advantages of administering a single dose are that the drug is fully identifiable and the integrity of the dosage form is protected until the actual time of administration. If the drug is not used and the container is intact, the drug can be removed and redistributed without affecting its integrity.