# 21 C.F.R. § 310.509 (2026): Parenteral drug products in plastic containers

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/CFR_T21_P310_S310_509

## Section

- **Citation:** 21 C.F.R. § 310.509 (2026)
- **Heading:** Parenteral drug products in plastic containers
- **Jurisdiction:** Federal
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** August 14, 2026
- **Source:** Compiled text
- **Location:** Title 21 CFR: Food and Drugs / Chapter I / Part 310 / Subpart E / § 310.509: § 310.509   Parenteral drug products in plastic containers.

## Text

(a) Any parenteral drug product packaged in a plastic immediate container is not generally recognized as safe and effective, is a new drug within the meaning of section 201(p) of the act, and requires an approved new drug application as a condition for marketing. An “Investigational New Drug Application” set forth in part 312 of this chapter is required for clinical investigations designed to obtain evidence of safety and effectiveness. (b) As used in this section, the term “large volume parenteral drug product” means a terminally sterilized aqueous drug product packaged in a single-dose container with a capacity of 100 milliliters or more and intended to be administered or used intravenously in a human. (c) Until the results of compatibility studies are evaluated, a large volume parenteral drug product for intravenous use in humans that is packaged in a plastic immediate container on or after April 16, 1979, is misbranded unless its labeling contains a warning that includes the following information: (1) A statement that additives may be incompatible. (2) A statement that, if additive drugs are introduced into the parenteral system, aseptic techniques should be used and the solution should be thoroughly mixed. (3) A statement that a solution containing an additive drug should not be stored. (d) This section does not apply to a biological product licensed under the Public Health Service Act of July 1, 1944 (42 U.S.C. 201). [62 FR 12084, Mar. 14, 1997]

## Nearby sections

- [21 C.F.R. § 310.501 (2026) § 310.501   Patient package inserts for oral contraceptives.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P310_S310_501.md)
- [21 C.F.R. § 310.502 (2026) § 310.502   Certain drugs accorded new drug status through rulemaking procedures.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P310_S310_502.md)
- [21 C.F.R. § 310.503 (2026) § 310.503   Requirements regarding certain radioactive drugs.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P310_S310_503.md)
- [21 C.F.R. § 310.509 (2026) § 310.509   Parenteral drug products in plastic containers.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P310_S310_509.md)
- [21 C.F.R. § 310.515 (2026) § 310.515   Patient package inserts for estrogens.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P310_S310_515.md)
- [21 C.F.R. § 310.517 (2026) § 310.517   Labeling for oral hypoglycemic drugs of the sulfonylurea class.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P310_S310_517.md)
- [21 C.F.R. § 310.518 (2026) § 310.518   Drug products containing iron or iron salts.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P310_S310_518.md)
- [21 C.F.R. § 310.519 (2026) § 310.519   Drug products marketed as over-the-counter (OTC) daytime sedatives.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P310_S310_519.md)
- [21 C.F.R. § 310.527 (2026) § 310.527   Drug products containing active ingredients offered over-the-counter (OTC) for external use as hair growers or for hair loss prevention.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P310_S310_527.md)
- [21 C.F.R. § 310.528 (2026) § 310.528   Drug products containing active ingredients offered over-the-counter (OTC) for use as an aphrodisiac.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P310_S310_528.md)
- [21 C.F.R. § 310.529 (2026) § 310.529   Drug products containing active ingredients offered over-the-counter (OTC) for oral use as insect repellents.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P310_S310_529.md)
- [21 C.F.R. § 310.530 (2026) § 310.530   Topically applied hormone-containing drug products for over-the-counter (OTC) human use.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P310_S310_530.md)
- [21 C.F.R. § 310.531 (2026) § 310.531   Drug products containing active ingredients offered over-the-counter (OTC) for the treatment of boils.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P310_S310_531.md)
- [21 C.F.R. § 310.532 (2026) § 310.532   Drug products containing active ingredients offered over-the-counter (OTC) to relieve the symptoms of benign prostatic hypertrophy.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P310_S310_532.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/CFR_T21_P310_S310_509. Check the current official text before relying on it. Not legal advice.