§379j–62. Authority to assess and use outsourcing facility fees — Inbound Citations

Citations to 21 U.S.C. § 379j–62 as a whole

• 21 U.S.C. § 353b(a)(9)

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  (9) The drug is compounded in an outsourcing facility that has paid all fees owed by such facility pursuant to section 379j–62 of this title.
• 21 U.S.C. § 353b(d)

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  (d) In this section:

  (1) The term “compounding” includes the combining, admixing, mixing, diluting, pooling, reconstituting, or otherwise altering of a drug or bulk drug substance to create a drug.

  (2) The term “essentially a copy of an approved drug” means—

  (A) a drug that is identical or nearly identical to an approved drug, or a marketed drug not subject to section 353(b) of this title and not subject to approval in an application submitted under section 355 of this title, unless, in the case of an approved drug, the drug appears on the drug shortage list in effect under section 356e of this title at the time of compounding, distribution, and dispensing; or

  (B) a drug, a component of which is a bulk drug substance that is a component of an approved drug or a marketed drug that is not subject to section 353(b) of this title and not subject to approval in an application submitted under section 355 of this title, unless there is a change that produces for an individual patient a clinical difference, as determined by the prescribing practitioner, between the compounded drug and the comparable approved drug.

  (3) The term “approved drug” means a drug that is approved under section 355 of this title and does not appear on the list described in subsection (a)(4) of drugs that have been withdrawn or removed from the market because such drugs or components of such drugs have been found to be unsafe or not effective.

  (A) The term “outsourcing facility” means a facility at one geographic location or address that—

  (i) is engaged in the compounding of sterile drugs;

  (ii) has elected to register as an outsourcing facility; and

  (iii) complies with all of the requirements of this section.

  (B) An outsourcing facility is not required to be a licensed pharmacy.

  (C) An outsourcing facility may or may not obtain prescriptions for identified individual patients.

  (5) The term “sterile drug” means a drug that is intended for parenteral administration, an ophthalmic or oral inhalation drug in aqueous format, or a drug that is required to be sterile under Federal or State law.