059-8 Wyo. Code R. § 8-7

Current through April 27, 2019

Section 8-7 - Outsourcing Facilities

(a) Outsourcing facilities shall be licensed by the FDA under section 503(b).

(b) Resident and non-resident outsourcing facilities shall be licensed as such in this State and annually renew their licensure.

(c) Outsourcing facilities located in this State shall be inspected by the Board.

(d) Outsourcing facilities shall complete all the requirements in this Chapter with the exception that they do not need VAWD^® accreditation.

(e) Outsourcing facilities shall:

• (i) Compound drugs by or under the direct supervision of a licensed pharmacist;

• (ii) Compound drugs in accordance with current good manufacturing practice (cGMP) as required by federal law;

• (iii) Ensure that pharmacists conducting or supervising compounding shall be proficient in the art of compounding and shall acquire the education, training, or experience to maintain that proficiency and become certified by a compounding certification program approved by the Board;

• (iv) Label compounded drugs with:
  • (A) Required drug and ingredient information;
  • (B) Facility identification;
  • (C) The following or similar statement: "This is a compounded drug. For office use only" or "Not for resale;" and

• (v) Only compound using bulk drug substances that meet specified FDA criteria. May also compound drugs that appear on an FDA shortage list if the bulk drug substances used comply with the aforementioned specified criteria.

(f) All licensed outsourcing facilities shall report to the Board the biannual reports they are required to provide to the FDA identifying the drugs compounded in the previous six (6) month period, including the drug's active ingredients, strength and dosage form.

059-8 Wyo. Code R. § 8-7

Amended, Eff. 10/31/2017.