Ch 19 P 37 Minimum Standards for Outsourcing Facilities

Question 1

Administer

Answer 1

The direct application of a drug to the body of a patient or research subject by injection, inhalation, ingestion or any other means as a result of an order of a licensed practitioner.

Question 2

Board

Answer 2

The New Mexico board of pharmacy.

Question 3

CFR

Answer 3

Code of federal regulations.

Question 4

Compounding

Answer 4

(1) manufacturing by an outsourcing facility in accordance with the conditions and requirements of Section 503B of the Federal Food, Drug, and Cosmetic Act; and
(2) manufacturing by a dual purpose facility in accordance with the conditions and requirements of Section 503A, and 503B as applicable, of the Federal Food, Drug, and Cosmetic Act; and
(3) the combining, admixing, mixing, diluting, pooling, reconstituting, or otherwise altering of a drug or bulk drug substance to create a drug; by an outsourcing facility or dual purpose facility.

Question 5

Dispense

Answer 5

The evaluation and implementation of a prescription, including the preparation and delivery of a drug or device to a patient or patient’s agent in a suitable container appropriately labeled for subsequent administration to or use by a patient.

Question 6

Distribute

Answer 6

The delivery of a drug or device other than by administering or dispensing.

Question 7

Dual purpose facility

Answer 7

An outsourcing facility licensed in the state of New Mexico that is also licensed in the state of New Mexico as a pharmacy or non-resident pharmacy.

Question 8

Manufacture

Answer 8

The steps in the preparation, propagation, processing or compounding of a drug - the making by chemical, physical, biological or other procedures of any articles which meet the definition of drugs and includes manipulation, sampling or control procedures resulting in the finished dosage form. Manufacture includes all the steps performed on the product itself, which do not affect intrinsically the safety, purity or potency of the product.

Question 9

Nonresident outsourcing facility

Answer 9

Any outsourcing facility located outside New Mexico, that ships, mails or delivers, in any manner, prescription drugs into New Mexico.

Question 10

Outsourcing facility

Answer 10

A facility that is currently registered with the Food and Drug Administration (FDA) as an outsourcing facility under Section 503B of the Federal Food, Drug, and Cosmetic Act, and that meets the requirements of that agency to engage in the compounding and distribution of sterile drugs.

Question 11

Pharmacist in charge

Answer 11

A pharmacist who accepts responsibility for the operation of a dual purpose facility or outsourcing facility in conformance with all laws and rules pertinent to the facility operational standards, the practice of pharmacy, and the distribution or dispensing of drugs and who is personally in full and actual charge of the facility and its personnel.

Question 12

REMS

Answer 12

A FDA approved risk evaluation and mitigation strategy.

Question 13

Resident state

Answer 13

The state in which the nonresident outsourcing facility is physically located in.

Question 14

The finished dosage form

Answer 14

Form of the drug which is or is intended to be dispensed or administered to the patient and requires no further manufacturing or processing other than packaging and labeling.