Community Pharmacy
Community pharmacyداروخانه (Community Pharmacy)
Practical, referenced tools for the community pharmacist: generic and brand products from the FDA Orange Book with the Iranian manufacturers, and non-sterile compounding with USP <795> beyond-use dating.
For professional use. Substituting one product for another follows the Iran FDA rules and the prescriber; always check the current product information (SmPC) of the product actually dispensed. Content reviewed October 2026.
Generic and brand products: Orange Book and Iranian manufacturers
Search by active ingredient or brand name to see every FDA-approved product of that ingredient — the brand (reference listed drug) and its generics, with strength, dosage form, applicant and therapeutic-equivalence code — and the Iranian manufacturers of the same medicine.
Type at least 3 letters.
TE codes beginning with A are therapeutically equivalent to the reference product (e.g. AB: bioequivalence demonstrated); codes beginning with B are not considered equivalent; a blank code means no multisource comparison (single source or OTC monograph). RLD = reference listed drug, the product generics are compared with; RS = reference standard for bioequivalence studies. Orange Book equivalence is a US regulatory status: substitution in Iran follows the Iran FDA list and the prescriber.
References:FDA – Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations) ↗FDA – Orange Book data files ↗
Non-sterile compounding in the pharmacy
Compound only when no suitable licensed product is available, from a documented formula with published stability, and label every preparation with a beyond-use date.
Beyond-use date calculator (USP <795>)
- Default BUD
- 14 days
- Storage
- Refrigerator (2–8 °C)
- Beyond-use date
- –
Choose the date compounded.
USP <795> (revision official 1 November 2023), default BUDs when there is no USP–NF compounded preparation monograph and no formulation-specific stability study. A monograph's BUD takes precedence; with stability data the BUD may be extended but not beyond 180 days, and preserved aqueous preparations extended beyond the default need antimicrobial-effectiveness testing (USP <51>). The BUD may never exceed the earliest expiry date of any ingredient. Water activity (aw) ≥ 0.60 counts as aqueous.
References:USP–NF 2026 <795> Pharmaceutical Compounding—Nonsterile Preparations ↗USP–NF 2026 <51> Antimicrobial Effectiveness Testing ↗
Master formulation record — what it must contain
- Name, strength or activity, and dosage form of the preparation
- Identity and amount of every ingredient, with their source or grade where relevant
- Container–closure system
- Complete compounding instructions, including equipment and the order of mixing
- Physical description of the finished preparation
- Beyond-use date and storage requirements, with the source of the BUD
- Labelling requirements and any quality-control checks
- Reference for the formulation (published formula or stability study)
USP <795> also requires a compounding record for each batch: date, lot numbers and expiry of the ingredients, quantities weighed, the compounder and verifier, the assigned BUD and any deviations.
Where to find validated formulas
- USP Compounded Preparation MonographsOfficial formulas with assigned BUDs, in USP–NF (subscription)
- SickKids – Compounding ServiceHospital for Sick Children, Toronto: paediatric oral suspensions (free)
- Nationwide Children's – Compounding FormulasNationwide Children's Hospital, Ohio: oral compounding formulas (free, informational)