SOW 7.18.24.pdf

SITE SPECIFIC TERMS AND CONDITIONS

Pharmaceutical Compounding Requirements

1. This is a list of the Carl R. Darnall Army Medical Center (CRDAMC) Department of Pharmacy minimum requirements of commercially prepared products.

2. The minimum requirements for commercially prepared products have been established based on the Department of Pharmacy’s mission and best pharmacy practices.

3. The Contractor must deliver orders to CRDAMC within 3-4 business days, preferred 2-3 business days, Monday through Friday not including federal Holidays from receiving the order.

a. The Contractor shall have at a minimum of one year experience in Compound

Pharmaceutical manufacturing.

b. The Contractor shall provide compounded pharmaceuticals meeting the minimum shelf-life and potency within +/-10% specification listed in the below Pharmaceutical Drug List.

i. Succinylcholine 20 mg/ml in 5 mL Syringe, minimum shelf-life 45 days at room temperature, preferred shelf-life greater than 45-90 days at room temperature.

ii. L.E.T Gel 3 mL in 5 mL Topical Syringe, minimum shelf-life 45 days at room temperature, preferred shelf-life greater than 45-90 days at room temperature.

iii. Phenylephrine 100 mcg/mL in 10 mL Syringe, minimum shelf-life 45 days at room temperature, preferred shelf-life greater than 45-90 days at room temperature.

iv. Oxytocin 30 units in 500 mL, Normal Saline bag, minimum shelf-life 30 days at room temperature, preferred shelf-life greater than 3-90 days at room temperature.

c. The Contractor shall be in compliance with Trade Agreements Act (ingredients supplied from authorized sources).

d. The Contractor shall be in compliance with Compounding Quality Act Title 1 of the

Drug Quality and Security Act of 2013.

e. The Contractor shall be in compliant with Current Good Manufacturing Practices

(cGMPs) requirements under section 501(a)(B).

f. The Contractor shall label the product with adequate directions for use (cGMPs) requirements under section 502(f)(1)) and make any modification to the packaging and labeling of product if CRDAMC requests due to patient safety concerns.

g. The Contractor shall be comply with all the requirements for facilities that compound drugs (cGMPs requirements under section 5038).

h. The Contractor shall have Food and Drug Administration (FDA) approval prior to marketing (cGMPs requirements under section 505).

i. The Contractor shall provide Quality Improvement/Quality Assurance (QI/QA) certification on every batch regardless of size.

j. The Contractor must comply with all DEA Licensing requirements for the manufacturing and distribution of controlled substances to the facility.

k. Documented proof for item (1) listed below must accompany the Request For

Quote, in order to be considered for award; additionally the vendor must be in compliance with items (2) and (3) below:

i. Certification/Accreditations: FDA or Pharmacy Compounding Accreditation

Board (PCAB) certification. The company will have an active certification which will be maintained annually to ensure the products are conducted with strict adherence to quality standards and principles of professional compounding.

ii. USP Chapter <797>: The compounding pharmacy must be compliant with ongoing changes and keeping up to date with requirements imposed by USP Chapter <797>. Products made are performed under the guidance set forth by this organization.

iii. Quality Control: A system of quality checks which include environmental monitoring, raw material testing, in-process testing, endotoxin testing, product sterility and fungal testing as well as potency and stability testing of finished preparations.

iv. May conduct studies to verify and potentially extend the stability and use-by dating on all preparations. Vendor shall provide QI/QA certification on every batch regardless of size.