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354 chapters · 3,831 sections in this title.
Ind. Code § 16-42-22.5-0.5 Applicability
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Sec. 0.5. This chapter does not apply to: (1) the compounding of; or (2) a compounded; drug for animal use. As added by P.L.136-2026, SEC.3.
Ind. Code § 16-42-22.5-1 "Bulk drug substance"
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Sec. 1. (a) As used in this chapter, "bulk drug substance" means a substance that is intended: (1) for incorporation into a finished drug product; and (2) to furnish pharmacological activity or other direct effect; in the diagnosis, cure, mitigation, treatment, or prevention of d…
Ind. Code § 16-42-22.5-2 "Compounding"
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Sec. 2. (a) As used in this chapter, "compounding" means the combining, admixing, mixing, diluting, pooling, reconstituting, or otherwise altering of a drug or bulk drug substance by: (1) a pharmacist licensed under IC 25-26; (2) a physician licensed under IC 25-22.5; or (3) an i…
Ind. Code § 16-42-22.5-3 Requirements to engage in compounding; nonresident pharmacies; maintenance of records
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Sec. 3. (a) A person may not engage in compounding unless the following requirements are met: (1) The bulk drug substance is not: (A) research grade, unless part of a study approved by an institutional review board; or (B) veterinary grade. (2) The bulk drug substance was manufac…