Glossary of Terms

A

Active Pharmaceutical Ingredient (API) — The biologically active components in a drug that produce the intended therapeutic effect. They are the core substances responsible for treating, preventing, or diagnosing a disease. Sometimes used interchangeably with Bulk Drug Substance (BDS) in practice.

Aliquot — A compounding technique used to accurately measure small quantities of potent drugs that are below the minimum weighable quantity (MWQ) of a balance. Aliquoting achieves precision by diluting the drug with an inert, compatible diluent, allowing a measured portion of the mixture to contain the desired amount of the drug.

American Society for Automation in Pharmacy (ASAP) — The American Society for Automation in Pharmacy (ASAP) is an organization that develops technical standards for pharmacy automation and data exchange. In pharmacy practice, ASAP is best known for publishing the standardized formats used to report controlled substance dispensing data to state Prescription Drug Monitoring Programs (PDMPs).

American Society of Health-System Pharmacists (ASHP) — The American Society of Health-System Pharmacists (ASHP) is a professional organization that represents pharmacists practicing in hospitals, health systems, and other healthcare settings. ASHP develops practice standards, educational resources, and guidance related to medication use, safety, compounding, and pharmacy operations to support high-quality patient care.

Application Programming Interface (API) — A set of rules and specifications that software programs can follow to communicate with each other. APIs are used to allow different software systems to integrate and share data.

ASAP Report — A standardized controlled substance dispensing report formatted according to specifications published by the American Society for Automation in Pharmacy (ASAP) and submitted to state Prescription Drug Monitoring Programs (PDMPs). ASAP reports are used to meet state reporting requirements for controlled substances and support regulatory monitoring and compliance.

ASHP Drug Shortages List — The ASHP Drug Shortages List is a resource maintained by the American Society of Health-System Pharmacists (ASHP) that tracks current and resolved drug shortages affecting healthcare providers in the United States. The list includes information on shortage status, affected products, and clinical considerations and is commonly used by pharmacists to monitor availability and plan mitigation strategies.

Auxiliary Labels — Additional labels with specific warnings or instructions for a medication.

B

Batch — A quantity of a compounded medication that is prepared in a single process.

Beyond-Use Date (BUD) — Beyond-Use Date (BUD) is the date or time after which a compounded medication, sterile or nonsterile, must not be used. It is determined based on the date and time the preparation is compounded and reflects the stability, sterility, and integrity of the formulation under specific storage conditions.

Bill of Materials (BOM) — A list of the raw materials, sub-assemblies, intermediate assemblies, sub-components, parts, and the quantities of each needed to manufacture an end product.

Bulk Drug Substance (BDS) — A bulk drug substance (BDS) is a substance intended to serve as the active ingredient in a drug product for human or veterinary use. It is functionally equivalent to an Active Pharmaceutical Ingredient (API) and is supplied in bulk form rather than as an FDA-approved finished drug product. In a compounding context, the use of a bulk drug substance is subject to FDA regulations and may be restricted based on product availability, approval status, and applicable federal guidelines.

Business-to-Business (B2B) — Transactions or interactions that occur between businesses, such as a pharmacy and a healthcare practice.

C

CAS Number — Chemical Abstracts Service Registry Number (CAS Number) is a unique numerical identifier assigned by the Chemical Abstracts Service (CAS), a division of the American Chemical Society, to every chemical substance described in the open scientific literature. It serves as a standardized, globally recognized way to unambiguously identify a specific chemical substance, regardless of its various names, synonyms, or nomenclature systems.

Centers for Medicare & Medicaid Services (CMS) — The Centers for Medicare & Medicaid Services (CMS) is a United States federal agency responsible for administering Medicare, Medicaid, and other national healthcare programs. CMS establishes standards for healthcare billing, provider identification, and data exchange, including the issuance and management of National Provider Identifiers (NPIs).

Certificate of Analysis (C of A / CoA) — A Certificate of Analysis (C of A / CoA) is a controlled document needed during compounding issued by a manufacturer or supplier of a chemical. It verifies that the product has undergone rigorous testing and provides detailed results for key parameters, including: identity, purity percentage, water content, physical properties, and other chemical measurements. It is necessary in order to calculate how much of a specific formula lot needs to go into a batch being formulated.

Chemical Grade — A classification that indicates which pharmacopeial or regulatory standard a chemical substance complies with. Chemical grades define requirements for identity, strength, purity, quality, and allowable impurities, and determine whether a substance is suitable for pharmaceutical use.

Clinical Difference Statement (CDS) — A clinical difference statement (CDS) is a determination made by a prescribing practitioner that a change in a compounded drug produces a clinical difference for an individual patient compared to the comparable approved drug. This statement is required under Section 503B(d)(2)(B) of the FDCA to justify compounding a drug that otherwise would be considered an "essentially a copy" of an approved drug. The statement must specify the change and confirm it produces a clinical difference for the patient. The FDA does not require a specific format, but the statement must clearly identify the change and its clinical impact.

Clinical Review — The process by which a pharmacist reviews a prescription for accuracy and safety, including potential drug interactions.

Compounding — The process of creating custom medications by combining or altering ingredients. This can involve mixing, reconstituting, or otherwise manipulating drug substances to create a specific formulation for a patient.

Compounding Software — Software used for managing the compounding process.

Contains NIOSH — NIOSH classifies chemicals and drugs based on specific hazard criteria to protect workers from exposure in occupational settings. For hazardous drugs, NIOSH uses a six-part definition: Carcinogenicity, Teratogenicity or developmental toxicity, Reproductive toxicity in humans, Organ toxicity at low doses (e.g., <10 mg/day in humans or <1 mg/kg/day in animals), Genotoxicity, and Structural or toxicity similarity to known hazardous drugs. Displayed in HiveRx as "NIOSH Hazard" and “Contains NIOSH hazardous ingredient”

Controlled Substance — A drug that has restrictions on its manufacture, possession, and use, due to the potential for addiction or abuse.

D

Data Entry Technician — The staff member responsible for entering prescription information into the pharmacy system.

DEA License — A DEA license is a registration issued by the Drug Enforcement Administration (DEA) that authorizes an individual practitioner, pharmacy, or facility to legally handle controlled substances. A valid DEA license is required to prescribe, dispense, compound, or distribute controlled substances in accordance with federal and state regulations.

DEA Schedule — A classification system established by the Drug Enforcement Administration (DEA) that categorizes controlled substances into schedules based on their accepted medical use, potential for abuse, and risk of dependence. DEA schedules range from Schedule I (no accepted medical use and high abuse potential) to Schedule V (accepted medical use with lower abuse potential).

Diluent — An inert, compatible substance used to dilute or carry an active ingredient or formulation to achieve a desired concentration, volume, or dosage form.

Dispensing — The process of preparing and providing medications to patients based on a prescription. This term is used interchangeably with **Fill**.

Dispensing Software — Software used for managing the dispensing process.

Drug Enforcement Administration (DEA) — The Drug Enforcement Administration (DEA) is a United States federal agency responsible for enforcing controlled substance laws and regulations. The DEA oversees the manufacture, distribution, prescribing, dispensing, and monitoring of controlled substances to prevent misuse, diversion, and illegal distribution.

Drug of Interest — A medication identified as having state-specific regulatory considerations. In HiveRx, a Drug of Interest is associated with one or more states where additional rules, restrictions, or reporting requirements may apply, and this information is displayed to support compliant prescribing, compounding, dispensing, and documentation.

Drug Shortage — A drug shortage occurs when the supply of a medication is insufficient to meet current or projected patient demand. Drug shortages may result from manufacturing, quality, distribution, or regulatory issues and can affect the availability of specific products, strengths, or dosage forms.

Drug Utilization Review (DUR) — Drug Utilization Review (DUR) is a process used to ensure the safe, effective, and appropriate use of medications. It involves reviewing prescriptions for potential issues. Pharmacies use DUR systems to comply with state and federal regulations, improve patient safety, and optimize therapeutic outcomes.

E

Electronic Health Record (EHR) — A digital version of a patient's paper chart, containing their medical history, diagnoses, medications, etc.

Electronic Medical Record (EMR) — A digital record of a patient's medical information within a specific practice or clinic.

Electronic Prescribing of Controlled Substances (EPCS) — Electronic Prescribing of Controlled Substances (EPCS) is a secure, digital system that allows prescribers to electronically transmit prescriptions for controlled substances (Schedules II–V) to pharmacies.

Enterprise Resource Planning (ERP) — A type of software system used to manage day-to-day business activities, such as accounting, procurement, project management, risk management, compliance, and supply chain operations.

Essential Copy — Essential Copy refers to a compounded drug that is identical or nearly identical to an FDA-approved, commercially available drug. According to FDA guidance, a compounded product is considered an essential copy if it shares the same active pharmaceutical ingredient(s), dosage strength (within 10% or easily substitutable), and route of administration as the approved product. This is generally prohibited under specific FDA regulations (Sections 503A/503B) unless the commercial drug is on the FDA's drug shortage list or a prescriber makes a clinically significant change for an individual patient.

European Pharmacopoeia (EP) — A chemical grade indicating the substance complies with the standards of the European Pharmacopoeia. EP-grade substances meet quality and purity requirements recognized across the European Union.

Excipient — Excipients are substances other than the active pharmaceutical ingredient (API) that are included in a drug formulation to support manufacturing, stability, delivery, or patient acceptability. They are not intended to have direct therapeutic effects but play essential roles in the quality, performance, and safe use of the medication.

F

FDA Drug Shortages Database — A publicly maintained resource provided by the FDA that tracks drugs experiencing supply shortages in the United States. The database includes information on current and resolved shortages, affected products, and availability status to support awareness and management of drug shortages.

Fill — The process of preparing and providing medications to patients based on a prescription. This term is used interchangeably with **Dispensing**.

First DataBank (FDB) MedKnowledge — The industry's most trusted data source and knowledge base. It provides comprehensive data on FDA-approved prescription drugs, over-the-counter medications, herbal remedies, dietary supplements, and medical devices. It is also critical for drug-drug interaction screening, dose range checks, duplicate therapy detection, drug-allergy interactions, drug-disease contraindications, and more.

Food and Drug Administration (FDA) — The Food and Drug Administration (FDA) is a United States federal agency responsible for protecting public health by regulating drugs, medical devices, food, and other related products. The FDA establishes and enforces standards related to the safety, quality, labeling, manufacturing, and distribution of regulated products, including those used in pharmacy compounding.

Formulary — A list of medications approved for use within a specific pharmacy or healthcare system.

Front End (Software) — Software that handles tasks outside of the lab environment including data entry, dispensing, order management, and shipping. This is in contrast to the "back end" or compounding aspects of a pharmacy. This term is synonymous with **PMS**.

G

GHS Hazard Category — A GHS classification that describes the severity of a chemical hazard for a specific endpoint. Hazard categories are assigned per hazard endpoint (such as acute toxicity, carcinogenicity, or reproductive toxicity). Category 1 indicates higher hazard severity, while Category 2 indicates lower severity for the same hazard class.

Globally Harmonized System (GHS) — The Globally Harmonized System of Classification and Labelling of Chemicals (GHS) is an internationally agreed-upon standard developed by the United Nations to harmonize the classification, labeling, and communication of chemical hazards worldwide. GHS provides a consistent framework for hazard classes, hazard categories, labels, and Safety Data Sheets (SDSs).

Good Manufacturing Practice (GMP) — Regulatory standards that ensure pharmaceutical products are consistently manufactured and controlled according to quality requirements appropriate for their intended use. GMP addresses processes related to production, quality control, documentation, facilities, and personnel to help ensure product safety and quality. In U.S. regulatory contexts, GMP is commonly referred to as current Good Manufacturing Practice (cGMP), emphasizing compliance with up-to-date requirements.

Gram (g / gm) — A unit of mass in the metric system equal to 1,000 milligrams. Grams may be used to express larger quantities of substances in pharmaceutical and compounding contexts.

Guidance for Industry (GFI) — The FDA's Guidance for Industry (GFI) #256, Compounding Animal Drugs from Bulk Drug Substances (BDS), outlines the FDA's enforcement policy regarding the compounding of animal drugs using BDS. It applies specifically to pharmacies and veterinarians involved in compounding animal medications.

H

No terms starting with H

I

Interactive Voice Response (IVR) System — An automated phone system for handling calls.

J

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K

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L

Label Printer — A device used to print prescription labels.

Lot — A batch of ingredients or medications that are prepared at one time. Lot information is used to track ingredients in the compounding process.

M

Master Formulation Record (MFR) — A comprehensive record that serves as a base for creating compound medications.

Medication List — A list of medications that a provider or practice is authorized to prescribe.

Milligram (mg) — A unit of mass in the metric system equal to one-thousandth of a gram (0.001 g). Milligrams are commonly used to express medication doses and chemical quantities in pharmaceutical compounding.

Minimum Weighable Quantity (MWQ) — The minimum weighable quantity is the smallest amount of material that can be weighed on a given balance with acceptable accuracy. MWQ is based on the balance’s sensitivity and allowable error and is used to determine when techniques such as aliquoting are required.

Multi-Tenant Architecture — A system where a single instance of software serves multiple customers or organizations

N

National Council for Prescription Drug Programs (NCPDP) — NCPDP stands for National Council for Prescription Drug Programs. It is a non-profit organization that develops standards for the electronic exchange of healthcare information related to pharmacy services.

National Drug Code (NDC) — A unique 10-digit or 11-digit number assigned to each medication listed with the U.S. Food and Drug Administration (FDA).

National Formulary (NF) — A chemical grade indicating the substance meets the standards published in the National Formulary. NF standards primarily apply to excipients and other non-active ingredients used in pharmaceutical preparations.

National Institute for Occupational Safety and Health (NIOSH) — National Institute for Occupational Safety and Health (NIOSH) is the U.S. federal agency responsible for conducting research and making recommendations to prevent work-related injury, illness, disability, and death.

National Provider Identifier (NPI) — The National Provider Identifier (NPI) is a unique 10-digit identification number issued by the Centers for Medicare & Medicaid Services (CMS) to healthcare providers and organizations in the United States. The NPI is used to identify providers in healthcare transactions, including billing, claims processing, and regulatory reporting, and does not confer licensure or prescribing authority.

NetSuite — An ERP system that is used as the source of truth for all things cost of goods and inventory. The system is used for creating sales orders, work orders, and purchase orders.

O

Office Use — Office use refers to medications compounded and distributed for administration within a healthcare setting without being tied to an individual patient prescription. Office-use compounding is permitted under specific regulatory frameworks, such as 503B outsourcing facilities, and is subject to federal and state requirements.

Order Intake — The process of receiving and entering prescription information into the system. This includes electronic submissions, faxes, phone calls, walk-ins, and transfers.

Over-the-Counter (OTC) — Medications that can be purchased without a prescription.

P

PAR Level — The minimum quantity of a product that should be kept on hand in inventory.

Parent–Child Model (Compounding) — A commonly used term in compounding practice that describes a relationship between formulations in which a base or master formula (the parent) is used to create one or more related formulations (children). Child formulations are derived from the parent and may differ by strength, volume, or other preparation-specific details while sharing the same underlying formulation basis.

Partial Fill — When a pharmacy dispenses only a portion of the prescribed quantity of a medication.

Patient Portal — A secure online platform that allows patients to access their medical information, request refills, and communicate with their pharmacy.

Patient-Specific Prescription — A patient-specific prescription is a medication order written for an identified individual patient and includes required patient-level information. In compounding, patient-specific prescriptions are required for 503A pharmacies and serve as the basis for preparing individualized medications.

Pharmacist — A healthcare professional licensed to dispense medications and perform clinical reviews of prescriptions.

Pharmacist Verification 1 (PV1) — The initial verification of a prescription performed by a pharmacist before compounding. This includes verifying data entry and checking for errors.

Pharmacist Verification 2 (PV2) — The final verification of a prescription by a pharmacist after compounding but before dispensing.

Pharmacy Management System (PMS) — A system used to manage various aspects of pharmacy operations, such as inventory, orders, and patient information. This term is synonymous with Front End (Software).

Pharmetika (PMK) — A pharmacy management system, used by some pharmacies within the network, that has some deficiencies.

PK (The Compounder) — A software system used for compounding operations. Some pharmacies also use PK for dispensing.

Point of Sale (POS) — The location where a transaction occurs; this also refers to the software used for sales transactions and managing payment processing.

Prescriber — A healthcare professional who can prescribe medications. NOTE: The terms ‘prescriber’ and ‘provider’ are used interchangeably, but we will standardize on prescriber for the app.

Prescriber Portal — A platform that allows physicians or healthcare providers to create and send prescriptions to the pharmacy.

Prescription (Rx) — A prescription (Rx) is an order for medication issued by a healthcare provider. The term is used instead of "sales order" in the pharmacy context to avoid confusion and align with common pharmacy language.

Prescription Drug Monitoring Program (PDMP) — Prescription Drug Monitoring Program, PDMP, is a state-run electronic database that tracks the prescribing and dispensing of controlled substances. These programs are designed to help prevent drug abuse, misuse, and diversion by providing prescribers with critical information about a patient’s prescription history. PDMPs are used to identify risks such as "doctor shopping," dangerous drug combinations, and potential medication misuse or addiction.

Prescription Verification (PV) — The process of checking a prescription for accuracy and completeness. This is typically done in two stages, PV1 and PV2.

Q

Quality Assurance/Quality Control (QA/QC) — Processes and procedures implemented to ensure the quality and safety of compounded medications.

R

Recipe — A set of instructions and ingredients for preparing a compounded medication. This term is generally not used unless for training or informational purposes.

Reciprocity Allowances — Regulatory provisions that permit a pharmacy or facility licensed in one state to compound or dispense medications for use in another state, subject to specific conditions and limitations. Reciprocity allowances vary by state and may depend on factors such as licensure status, prescription requirements, and the type of compounding performed.

Role-Based Access Control (RBAC) — Role-Based Access Control is a security model that manages access to systems, applications, and data based on the roles individuals hold within an organization. Rather than assigning permissions directly to users, RBAC groups the permissions into roles, such as "admin," "pharmacy manager," "technician," and assigns those roles to users. This ensures individuals only have access to resources necessary for their job and reduces the risk of unauthorized access.

S

Safety Data Sheet (SDS) — A standardized document that provides comprehensive information about the properties, hazards, safe handling, storage, and disposal of chemical substances used in pharmaceutical research, manufacturing, and healthcare settings. SDSs are required under the Globally Harmonized System (GHS) and must follow a consistent 16-section format. Any substance meeting hazard criteria must have an SDS, which must be accessible to employees and updated regularly to comply with regulations such as OSHA’s Hazard Communication Standard.

Schedule II Controlled Substance — A Schedule II controlled substance is a drug classified by the DEA as having an accepted medical use but a high potential for abuse and dependence. Schedule II substances are subject to strict regulatory controls, including prescribing, dispensing, storage, recordkeeping, and reporting requirements.

Schedule III–V Controlled Substances — Schedule III–V controlled substances are drugs classified by the DEA as having accepted medical uses and progressively lower potential for abuse and dependence compared to Schedule II substances. While still regulated, Schedule III–V substances are subject to less restrictive controls, with requirements varying by schedule and jurisdiction.

SIG Code — A set of abbreviations and symbols used to provide instructions to a patient regarding the administration of a medication.

Standard Operating Procedure (SOP) — Detailed, written instructions to achieve uniformity of the performance of a specific function.

Stock Solution Formula — A predefined formula used to create a concentrated solution that can be diluted to prepare one or more final formulations. Stock solution formulas are typically used to support consistency, efficiency, and accuracy when preparing multiple related compounds.

SureScript — A network that enables the secure electronic transmission of prescriptions between prescribers and pharmacies.

T

Tall Man Lettering — A medication safety practice that uses mixed-case lettering to highlight differences in drug names that look or sound similar. It is intended to help reduce the risk of medication errors by drawing attention to distinguishing portions of drug names during prescribing, dispensing, and administration.

U

Unit of Measure (UOM) — A standardized unit used to quantify and report the amount of a medication or substance. UOMs are used across prescribing, compounding, dispensing, administration, and billing to support clarity and consistency and reduce the risk of medication errors.

United States Pharmacopeia (USP) — A chemical grade indicating the substance meets the standards published by the United States Pharmacopeia. USP-grade substances comply with established requirements for identity, strength, quality, and purity and are acceptable for use in pharmaceutical compounding and manufacturing in the United States.

V

No terms starting with V

W

White Label — When a product or service is rebranded to appear as if it is provided by a different company.

Workflow — The sequence of steps involved in a process.

X

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Y

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Z

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