Compounding and injectables glossary
The technical and regulatory terms that show up in the day-to-day of prescribing compounded preparations — explained plainly, for physicians, clinics and managers.
AFE — Company Operating Authorization
Authorization granted by Anvisa that enables a company to carry out activities with medicines and inputs. It is the basic regularity document of a compounding pharmacy.
Special Authorization (AE)
Authorization required of pharmacies that compound substances under special control (Ordinance 344/98), such as many hormones and psychotropics.
Anvisa
Brazil’s National Health Surveillance Agency, responsible for regulating and overseeing medicines, inputs and compounding activity in Brazil.
Good Compounding Practices (GCP)
A set of rules (such as RDC 67/2007) defining structure, process and control requirements to ensure the quality and safety of compounded preparations.
Cold chain
Continuous temperature control in the storage and transport of heat-sensitive inputs, such as many sterile injectables. A break can compromise the product with no visible sign.
Certificate of Analysis / Per-batch report
Document issued by the pharmacy for each batch, attesting to parameters such as potency, sterility and endotoxins. It is the main quality evidence of a compounded preparation.
Quality control
The set of analyses and checks that confirm whether a compounded preparation meets its specifications. It depends on the pharmacy’s analytical capability.
Dermocosmetic
A compounded topical product with actives for skin or hair, common in dermatology and trichology. The choice of vehicle affects stability and performance.
Sanitary dossier
An organized set of documents proving the compliance of the clinic’s pharmaceutical chain: pharmacy regularity and per-batch reports. See the article on the topic.
Bacterial endotoxins
Bacterial cell-wall residues that, even without living microorganisms, can cause pyrogenic reactions. Their control is essential in injectables.
Sterility
Absence of microbiological contamination. A non-negotiable requirement for sterile injectables, proven by a specific test.
Stability
The product’s ability to keep its characteristics (including potency) over time and under given storage conditions. It defines the shelf life.
Excipient
A substance with no therapeutic action that makes up the formula alongside the active, influencing stability, absorption and the final form. It relates to the vehicle.
Compounding (magistral) pharmacy
A licensed establishment that prepares individualized medicines and products from a prescription, following good practices and under a technical director.
Dosage form
The final presentation of the compounded preparation (capsule, solution, cream, injectable, etc.), chosen according to the protocol’s goal and route of administration.
API — Active Pharmaceutical Ingredient (raw material)
The active substance of the formula. Its provenance and traceability directly affect the quality of the compounded preparation.
Sterile injectable
A compounded product for injectable administration, which requires proven sterility, endotoxin control and potency per batch, plus a cold chain when heat-sensitive.
Batch (lot)
A defined quantity of product manufactured in a single cycle, identified by a number. Each batch should have its report and allow traceability.
Compounded preparation (magistral)
A medicine or product prepared individually by the pharmacy from a prescription, in tailored concentration and form. It requires a prescription.
Peptide
A molecule formed by amino acids, sensitive to process and storage conditions. In injectables, it requires high-precision compounding and analytical capability.
Pyrogen
A substance capable of causing fever and systemic reactions. Endotoxins are the main pyrogenic concern in injectables.
Ordinance 344/98
The rule regulating substances and medicines under special control. Compounding these items requires a Special Authorization.
Prescription
The document from a qualified professional that authorizes and specifies the compounded preparation. No compounded preparation is dispensed without a valid prescription.
Traceability
The ability to link each product to its batch, formula, pharmacy and, where relevant, patient/procedure. The basis of compliance and safety.
RDC — Collegiate Board Resolution
A type of rule issued by Anvisa. RDC 67/2007, for example, covers good compounding practices.
Technical Director (RT)
The pharmacist technically responsible for the pharmacy, ensuring good practices are followed day to day.
Potency (assay)
The real active concentration in the final product against what was prescribed. The potency report proves whether what was prescribed was actually delivered.
Shelf life (expiry)
The period during which the product keeps its quality and potency under the indicated storage conditions. It derives from stability studies.
Vehicle
The base that carries the active in the dosage form (gel, cream, solution, etc.), influencing stability, absorption and user experience.
Informational content. These definitions are practical aids and do not replace current legislation (Anvisa and local authorities) or the assessment of qualified professionals. Compounded preparations require a prescription.
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