Outsourcing facility definition

Outsourcing facility means a facility that is engaged in the compounding of sterile drugs and is currently registered as an outsourcing facility with the U.S. Secretary of Health and Human Services and that complies with all applicable requirements of federal and state law, including the Federal Food, Drug, and Cosmetic Act.

Outsourcing facility means a facility that is engaged in the compounding and sale of sterile drugs and is registered as an outsourcing facility with the United States food and drug administration.

Outsourcing facility means a facility that is engaged in the compounding of sterile drugs and is

Examples of Outsourcing facility in a sentence

• Very familiarSomewhat familiarNot familiarCompounded drugs (medications prepared to meet a patient-specific need)ooo503A Compounding pharmacy (a pharmacy that prepares compounded medications prescribed by practitioners to meet a patient-specific need)ooo503B Outsourcing facility (a facility that compounds larger quantities without the receipt of a patient- specific prescription)ooo 2.

• Outsourcing facility personnel shall permit an authorized inspector or law enforcement official, who shows proper identification, to enter and inspect the facility and delivery vehicles at reasonable times and in a reasonable manner, and to inspect the facility records and written operating procedures.

• If the department issues an order under this subsection to incorporate the revision by reference, the department shall not make any changes to the revision.(3) "Outsourcing facility" means that term as defined in 21 USC 353b.History: 1978, Act 368, Eff.

• The name and concentration of each active ingredient.b. The date that the preparation was compounded.c. The beyond-use date of the compounded preparation.d. If the compounded preparation was prepared from batch preparation compounding, the batch identification or control number.e. Special storage and handling instructions, if applicable.20.19(3) Outsourcing facility distribution or dispensing.

• Outsourcing facility" or "virtual outsourcing facility" means a facility at one geographic location or address that is engaged in the compounding of sterile drugs and has registered with the FDA as an outsourcing facility pursuant to 21 U.S.C. § 353b.

More Definitions of Outsourcing facility

Outsourcing facility means a facility that:

Outsourcing facility means a facility at one geographic location or address that:

Outsourcing facility means a facility at one geographic location or address which is engaged in anticipatory compounding of sterile drugs and complies with section 503(b) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 353(b)].

Outsourcing facility means a pharmacy or facility that is registered by the United States food and drug administration pursuant to 21 U.S.C. 353b and either registered or endorsed by the board.

Outsourcing facility means a facility at one geographic location or address that is engaged in the compounding of sterile drugs and has registered with the FDA as an outsourcing facility pursuant to 21 U.S.C. § 353b.

Outsourcing facility means a facility at one geographic location or address that is engaged in anticipatory compounding of sterile drugs and complies with the United States food and drug administration section 503B of the Federal Food, Drug, and Cosmetic Act (11/27/2013).

Outsourcing facility means a facility that is located within the United States of America at one address that is engaged in the compounding of sterile drugs and nonsterile drugs; has registered as an outsourcing facility with the federal Food and Drug Administration under Section 503B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 353b); and is doing business within or into Delaware.