Are there any laws governing the substitution of generic drugs for brand name drugs?

Yes, California has laws governing the substitution of generic drugs for brand name drugs. Generally, the State Board of Pharmacy is responsible for the safe and effective substitution of generic drugs for brand name drugs. The Board of Pharmacy establishes rules governing the prescribing and dispensing of generic drugs, including when and how generic drugs may be substituted for brand name drugs. Additionally, the Board of Pharmacy sets requirements for pharmacies to follow when considering whether to substitute generic drugs for brand name drugs. One requirement is that a pharmacy must determine that the generic drug is therapeutically equivalent to the brand name drug. This means that the generic drug must have the same active ingredients as the brand name drug, and that the active ingredients must be present in the same strength and dosage form. If a pharmacy determines that a generic drug is therapeutically equivalent, the pharmacist may substitute the generic drug for the brand name drug. In addition, a pharmacy must also determine that the generic drug is bioequivalent to the brand name drug. Bioequivalence means that the generic drug will deliver the same amount of active ingredients to the body over a similar period of time as the brand name drug. If a pharmacy determines that a generic drug is bioequivalent, the pharmacist may substitute the generic drug for the brand name drug. In sum, California has laws governing the substitution of generic drugs for brand name drugs. Generally, pharmacies must determine that the generic drug is both therapeutically equivalent and bioequivalent to the brand name drug before making a substitution.

Are there any laws governing the substitution of generic drugs for brand name drugs?

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