Compounding and Sterile Products
Compounding is prescription-driven
Compounding is preparation of a tailored product for an identified patient under a valid prescription. USP <795> (nonsterile), <797> (sterile), and <800> (hazardous drugs) set practice standards, and Alabama rules incorporate them. A 503A pharmacy compounds under a patient-specific prescription (or limited anticipatory basis) and may not routinely compound essentially a copy of a commercially available product, or a demonstrably difficult-to-compound drug, absent an exception. Bulk substances must come from an FDA-registered establishment with a valid certificate of analysis.
Sterile compounding requires appropriate facilities (ISO-classified buffer and ante areas), environmental monitoring, validated processes, garbing, and cleaning and sanitization. Beyond-use dates depend on the category of preparation (immediate, low-, medium-, high-risk) and storage conditions; the BUD rationale must be documented.
Hazardous drugs: containment, closed-system transfer devices, PPE, and negative-pressure space where required. Do not confuse <800> containment with <797> sterility.
Traps: assuming compounded products escape labeling and lot/expiry records; treating a copy product as permissible because a prescriber requested it; using bulk API without documentation; extending a BUD without stability support; confusing 503A with 503B outsourcing facilities, which are federally registered and inspected differently.
Rule of thumb: prescription + formulation justification + documented process + defensible BUD = compliant preparation.