Pharmaceutical Equivalents/ Alternatives/ Substitution

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Pharmaceutical Equivalents

Drug products in identical dosage forms that contain the same active ingredient(s), ie, the same salt or ester, are of the same dosage form, use the same route of administration, and are identical in strength or concentration (eg, chlordiazepoxide hydrochloride, 5-mg capsules). Pharmaceutically equivalent drug products are formulated to contain the same amount of active ingredient in the same dosage form and to meet the same or compendial or other applicable standards (ie, strength, quality, purity, and identity), but they may differ in characteristics such as shape, scoring configuration, release mechanisms, packaging, excipients (including colors, flavors, preservatives), expiration time, and, within certain limits, labeling. When applicable, pharmaceutical equivalents must meet the same content uniformity, disintegration times, and/or dissolution rates. Modified-release dosage forms that require a reservoir or overage or certain dosage forms such as prefilled syringes in which residual volume may vary must deliver identical amounts of active drug ingredient over an identical dosing period.

Pharmaceutical Alternatives

Drug products that contain the same therapeutic moiety but as different salts, esters, or complexes. For example, tetracycline phosphate or tetracycline hydrochloride equivalent to 250 mg tetracycline base are considered pharmaceutical alternatives. Different dosage forms and strengths within a product line by a single manufacturer are pharmaceutical alternatives (eg, an extended-release dosage form and a standard immediate-release dosage form of the same active ingredient). The FDA currently considers a tablet and capsule containing the same active ingredient in the same dosage strength as pharmaceutical alternatives.

Pharmaceutical substitution

The process of dispensing a pharmaceutical alternative for the prescribed drug product. For example, ampicillin suspension is dispensed in place of ampicillin capsules, or tetracycline hydrochloride is dispensed in place of tetracycline phosphate. Pharmaceutical substitution generally requires the physician’s approval.

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