Mississippi Administrative Code
Title 30 - Mississippi State Board of Public Accountancy
Part 3001 - MISSISSIPPI PHARMACY PRACTICE REGULATIONS
Article XLVII - PHYSICIAN DISPENSING FACILITY PERMITS
Section 30-3001-XLVII.9 - Dispensing Compounded Products

Universal Citation: MS Code of Rules 30-3001-XLVII.9

Current through December 10, 2024

1. Prior to engaging in compounding pharmaceuticals for dispensing, a physician dispensing facility shall obtain a compounding certificate from the Mississippi Board of Pharmacy.

a. To obtain a compounding certificate, an applicant must complete a compounding certificate application. A compounding certificate is required for each physician dispenser. The physician dispenser shall not delegate any part of the compounding process to another person.

b. A compounding certificate will expire when the physician dispensing permit expires and can be renewed at the time the physician dispensing permit is renewed.

c. Compounding for dispensing, without obtaining the compounding certificate, shall be grounds for disciplinary action.

d. Every physician dispenser that engages in compounding for dispensing shall keep records of all compounded products that are dispensed to patients. Such records shall be readily available for authorized inspection for six (6) years from the date of dispensing.

e. Any dispensing physician with an active compounding certificate for dispensing is subject to a compounding inspection by the Board.

2. Every dispensing physician that is engaged in compounding pharmaceuticals for dispensing shall comply with USP 795, USP 797, and USP 800 when compounding in the scope of those chapters.

3. For the purposes of this Section, flavoring is not considered compounding. In addition, the combining of commercially manufactured, ready-to-use products shall be exempt from USP 795 compounding standards under the following conditions:

a. No more than four (4) commercially manufactured ready-to-use products (that have not been manipulated) are used;

b. Compounding is not done in anticipation of orders;

c. Must follow USP 795 beyond use dates (BUDs);

d. The prescription label complies with all related USP chapter requirements as well as the labeling requirements set forth in this regulation.

4. A physician dispenser may compound for dispensing to an individual patient, medications that are not commercially available in the marketplace in compliance with Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act. This includes compounding a copy of a commercial product when that commercial product is not available as evidenced by either of the following:

a. Products that appear as unresolved status on the FDA drug shortage list in effect under Section 506E of the FD&C Act; or

b. Products discontinued and no longer marketed by the manufacturer.

5. A physician dispenser shall not compound for dispensing products that appear on the FDA List of Drugs withdrawn or removed from the market for safety reasons or on the FDA List of Drug products that present demonstrable difficulties in compounding.

6. A physician dispenser shall not offer compounded human drug products to other practitioners or to pharmacies for resale or dispensing. A physician dispenser may not dispense compounded product from another practitioner or that was compounded by a 503A or 503B pharmacy.

7. Nothing in this section prohibits a physician from compounding for immediate administration or requires a physician dispenser to obtain a compounding certificate from the MS Board of Pharmacy for compounding for administration.

Disclaimer: These regulations may not be the most recent version. Mississippi may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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