The primary label of each compounded medication should include a statement notifying the patient that the medication has been compounded

Labeling of pharmaceutical products

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Labeling should be done according to state and federal regulations. Usually, labeling information includes the (1) generic or chemical names of the active ingredients, (2) strength or quantity, (3) pharmacy lot number, (4) beyond-use date, and (5) any special storage requirements.

The primary label of each compounded medication should include a statement notifying the patient that the medication has been compounded

When a commercial drug product has been used as a source of the drug, the generic name of the drug product, not the proprietary name, should be placed on the label. Inactive ingredients and vehicles should also be listed on the label. If no expiration date is provided on the chemicals or materials that are used, a system of monitoring should be established (e.g., placing the date of receipt of the materials on the label of the container, or whatever the state board of pharmacy requires). Monitoring expiration dates will ensure that materials, ingredients, and supplies are rotated so that the oldest stock is used first.

The use of specially coined names or short names for convenience should be discouraged. Such names can cause difficulty in emergency departments if an overdose or accidental poisoning has occurred or if health professionals treating the patient need to know what the patient has been taking. If batch quantities of a preparation are compounded, alot number should be assigned and placed on the labels. Surplus prepared labels should be destroyed.

If excess preparation is compounded or additional quantities are prepared in anticipation of future requests for the preparation, the pharmacist should have written procedures for the proper labeling of the excess preparation. Labeling should include the (1) complete list of ingredients, (2) preparation date, (3) assigned beyond-use date, (4) appropriate testing/ published data, and (5) control numbers. The preparation should then be entered into the inventory and stored appropriately to help ensure its strength, quality, and purity. When the compounding process is completed, the excess preparation should be reexamined for correct labeling and contents.

IACP Recommended Labeling

The International Academy of Compounding Pharmacists (IACP) has developed recommendations for labeling preparations compounded in response to a prescription for a specific patient. The primary label of each compounded medication should include a statement notifying the patient that the medication has been compounded. If space limitations or clinical reasons preclude inclusion on the primary label, the information may be affixed through auxiliary labeling (e.g., if a label applied directly to the primary container could affect the quality of the medication, the label and statement should instead be applied to exterior packaging).

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In either case, the statement should be prominently displayed in the medication labeling. IACP recommends the following statement: “This medicine was specially compounded in our pharmacy for you at the direction of your prescriber.” Alternative language that clearly states that the medication has been compounded may be used.

In addition, IACP supports state regulations that require the following pieces of information on all prescription labels, including compounded medication labels: (1) patient’s name, (2) prescriber’s name, (3) name, address, and phone number of the pharmacy preparing the medicine, (4) prescription number, (5) medication’s established or distinct common name, (6) strength, (7) statement of quantity, (8) directions for use, (9) date prescription is filled, (10) expiration/beyond-use date, (11) storage instructions, and (12) any other state labeling requirements.

IACP Recommended Labeling for Medications Compounded for Office Use

Physicians and institutions occasionally ask pharmacists to compound non-patient-specific medications that are not commercially available and that must be administered by the prescriber. For example, FDA requires certain medications to be administered by the prescriber. In other cases, preparations for office use must be compounded in advance and immediately available for the physician to use in emergencies.

For these medications, IACP recommends language to be included on the primary label of each package. If space limitations or clinical reasons preclude inclusion on primary labeling, the information may be affixed through auxiliary labeling (e.g., if a label applied directly to the primary container could affect the quality of the medication, the label and statement should instead be applied to exterior packaging). In either case, the statement should be prominently displayed in the medication labeling.

IACP recommends the following statement to help ensure (1) that the medication is administered properly and (2) that the prescriber and the patient are aware that the medication has been compounded: “This medicine was compounded in our pharmacy for use by a licensed professional only.” Alternative language clearly stating that the medication has been compounded and is intended for in-office administration only may be used.

In addition, IACP supports state regulations that require the following pieces of information on the labels of office-use compounds: (1) name, address, and telephone number of the pharmacy preparing the medicine, (2) lot number, (3) the medication’s established or distinct common name, (4) strength, (5) statement of quantity, (6) date prescription is filled, (7) beyond-use date, (8) storage instructions; and (9) any other state labeling requirements

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