Storage And Handling - NAPLEX

Single-dose opened outside ISO 5: use within $1$ hour. USP <797> restricts to 1 hour outside ISO 5 to minimize contamination risks in non-sterile environments.

Dispense in tight container with desiccant when appropriate. Tight containers with desiccants absorb moisture, preventing hygroscopic drugs from absorbing water and losing potency.

FEFO (first-expire, first-out) stock rotation. FEFO prioritizes expiring stock to ensure medications are used before expiration, reducing waste and safety risks.

Store separately with restricted access and documented chain of custody. Separate storage with access controls and documentation ensures compliance, security, and traceability for clinical trials.

Store in a designated area with containment strategies and restricted access. USP <800> mandates containment and restricted access to minimize exposure risks to hazardous drugs for personnel safety.

Store above freezing; avoid $\le 0,^{\circ}\text{C}$ exposure. The label prevents freezing to avoid physical damage like crystallization or emulsion breaking in sensitive formulations.

Keep in original container; protect from light and moisture. Sublingual nitroglycerin requires protection from light and moisture to prevent degradation and maintain potency.

Do not crush or chew. Enteric-coated tablets must remain intact to ensure release in the intestine, avoiding gastric irritation or premature dissolution.

Multi-dose vial after first puncture: $28$ days unless manufacturer states otherwise. USP <797> defaults to 28 days post-puncture for multi-dose vials to prevent microbial contamination unless specified otherwise.

Single-dose opened in ISO 5: use within $6$ hours. USP <797> allows 6-hour use in ISO 5 to maintain sterility in controlled environments for compounded sterile preparations.

Water-containing topical/dermal: BUD not later than $30$ days. USP <795> sets a 30-day BUD for topical water-containing compounds to balance stability and contamination risks at room temperature.

Water-containing oral: BUD not later than $14$ days refrigerated. USP <795> requires refrigeration and a 14-day BUD for water-containing orals to prevent microbial growth.

Non-aqueous: BUD not later than $6$ months or earliest ingredient expiry. USP <795> limits BUD for non-aqueous compounds to minimize stability risks based on ingredient expiration.

Unit-dose packaging (single-dose, ready-to-administer). Unit-dose packaging ensures accurate dosing, reduces errors, and complies with hospital standards for oral solids.

Protects contents from effects of light. USP light-resistant containers block light transmission to avoid photochemical reactions that degrade drug efficacy.

Impermeable to air or other gases under ordinary conditions. USP hermetic containers seal against gases to maintain sterility or prevent oxidation in sensitive pharmaceutical products.

Protects from extraneous solids and loss under ordinary conditions. USP specifies well-closed containers to shield against solid contaminants and prevent content loss during routine storage and transport.

Protects from contamination by liquids/solids/vapors; loss/efflorescence. USP defines tight containers to safeguard contents from external contaminants and internal changes like efflorescence under normal handling.

Tight container (moisture-resistant closure). Tight containers prevent moisture ingress, which could lead to hydrolysis or degradation of moisture-sensitive drugs.

USP <1000>–<1999>. USP chapters in the 1000-1999 range offer non-mandatory guidance to support best practices without regulatory enforcement.

USP <1>–<999>. USP chapters numbered below 1000 set mandatory, enforceable standards for pharmaceutical practices, including compounding, as established by regulatory bodies.

Frozen: $-25$ to $-10,^{\circ}\text{C}$. Freezing at -25 to -10°C ensures long-term stability for medications requiring ultra-low temperatures to prevent chemical breakdown.

Store in light-resistant container; minimize light exposure. The label requires light protection to prevent photodegradation, which can reduce drug potency or cause instability.

Controlled room temperature: $20$–$25,^{\circ}\text{C}$. USP defines controlled room temperature as 20-25°C to maintain medication stability under typical pharmacy conditions.