Introduction
The Drug Tracking System in Turkey, known in Turkish as İlaç Takip Sistemi or İTS, is one of the most important compliance mechanisms in Turkish pharmacy law. It is designed to ensure traceability of medicines throughout the pharmaceutical supply chain, from production or importation to wholesale distribution, pharmacy stock movement and final patient supply. For pharmacies, İTS is not merely a technical software system. It is a legal obligation, an inspection tool, a stock management instrument and a public health protection mechanism.
In Turkey, pharmacies are not ordinary retail businesses. They are healthcare institutions opened under the ownership and responsible management of pharmacists. The Regulation on Pharmacists and Pharmacies defines a pharmacy as a healthcare institution opened under the ownership and responsible management of a pharmacist, and defines İTS as the system operated by the Turkish Medicines and Medical Devices Agency, TİTCK, to track medicines through notifications starting from production or importation and continuing through every point of movement.
This means that every pharmacy must treat İTS compliance as part of its daily legal practice. Medicine purchases, sales, returns, pharmacy-to-pharmacy exchanges, destruction of expired or deteriorated medicines, revenue declarations and electronic records may all have İTS-related consequences. Failure to comply may lead to inspection findings, administrative sanctions, temporary system access restrictions, reimbursement problems, professional disciplinary consequences and, in serious cases, judicial or administrative proceedings.
Legal Framework of İTS Compliance
The main legal basis for İTS compliance by pharmacies is the Regulation on Pharmacists and Pharmacies. Article 27 of the Regulation provides that pharmacies must use the medicine tracking system operated by the competent institution for human medicinal products. It expressly requires İTS notifications for medicine purchases, sales, returns to the pharmaceutical warehouse from which the medicine was obtained, returns to other warehouses in cases of force majeure or pharmacy closure, pharmacy-to-pharmacy exchanges, and destruction of expired or deteriorated medicines.
The same provision also states that the buyer shown in the İTS sale, return or exchange notification must be the same as the buyer stated in the corresponding transaction documents. This rule is important because İTS compliance is not limited to making an electronic entry. The electronic record, invoice, transaction document and actual physical movement of the medicine must be consistent.
The Regulation also requires all medicines sold in pharmacies to be recorded electronically and requires those records to be preserved for presentation during inspections. In addition, pharmacies must keep inspection, personnel and trainee registers approved through the relevant professional chamber system.
Purpose of the Drug Tracking System in Turkey
The purpose of İTS is to provide traceability and security in the pharmaceutical supply chain. Medicines directly affect human health, and any uncontrolled movement of medicines may create risks such as counterfeit products, illegal trade, reimbursement fraud, stock manipulation, expired medicine circulation and unsafe supply.
İTS creates a digital chain of custody. Each medicine package can be followed through its movement within the legal supply chain. From a public health perspective, this helps authorities and pharmacies identify where a medicine came from, where it went, whether it was sold, whether it was returned, whether it was exchanged, and whether it was destroyed because it expired or deteriorated.
For pharmacies, İTS also provides protection. A pharmacy that keeps accurate İTS records can show that it purchased medicines from authorized channels, supplied them lawfully, handled returns correctly and destroyed expired medicines through proper procedures. In a dispute, inspection or audit, accurate İTS records may support the pharmacy’s legal position.
İTS as a Daily Pharmacy Compliance Obligation
İTS compliance is not a one-time obligation. It is part of daily pharmacy operation. Every time a pharmacy purchases a human medicinal product, supplies it to a patient, returns it to a warehouse, exchanges it with another pharmacy or removes it for destruction, the relevant İTS notification must be made according to the applicable rules.
This creates a duty of continuous accuracy. The pharmacy’s physical stock, electronic stock, invoices, İTS notifications and internal pharmacy software records should match. A discrepancy may not always mean wrongdoing, but it is a risk signal. During an inspection, inconsistent stock may lead to questions about missing products, unauthorized sales, unrecorded returns, incorrect destruction or mistakes in electronic notification.
For this reason, pharmacies should not treat İTS entries as clerical afterthoughts. İTS compliance should be built into the workflow of receiving medicines, storing products, dispensing prescriptions, handling returns and removing expired products.
Purchase Notifications and Stock Entry
When a pharmacy receives medicines from an authorized pharmaceutical warehouse, the medicine movement must be reflected in İTS. The pharmacy must ensure that the products physically received correspond to the products recorded electronically. Batch, serial, barcode and package-level information should be consistent with the invoice and İTS record.
The key legal point is traceability. If a pharmacy receives a product but fails to confirm or correctly process the electronic movement, the medicine may appear inconsistent in the system. If the pharmacy later attempts to sell, return or destroy the medicine, the incorrect stock record may create operational and legal problems.
A pharmacy should therefore have a stock entry protocol. When medicines arrive, staff should check the supplier, invoice, quantity, barcode information, physical package condition, expiry date, cold-chain status and İTS compatibility. High-cost medicines, cold-chain medicines, controlled medicines and specialty products should receive enhanced review.
Sale Notifications and Patient Supply
Sale notification is one of the most important İTS processes for pharmacies. When a medicine is dispensed, the relevant movement must be reflected in the medicine tracking system. This is especially important for prescription medicines, reimbursed medicines and high-cost products.
The legal function of the sale notification is to show that the medicine left pharmacy stock through a lawful patient supply transaction. If a medicine is physically supplied but not properly recorded, İTS stock may show a product still present. If a medicine is recorded as sold but physically remains in stock, this also creates inconsistency.
The Regulation on Pharmacists and Pharmacies requires electronic records of all medicines sold in the pharmacy to be preserved and presented during inspections when requested. This means that sale data should be compatible not only with İTS but also with prescription files, SGK/MEDULA records, invoices, patient transactions and pharmacy software.
Return Notifications to Pharmaceutical Warehouses
Pharmacies may need to return medicines to the pharmaceutical warehouse from which they were obtained. Returns may arise from product defects, recall procedures, incorrect supply, stock management needs, damaged packaging, expiry concerns or other lawful reasons.
Article 27 of the Regulation expressly includes returns to the warehouse from which the medicine was obtained within the transactions requiring İTS notification. It also recognizes returns to other warehouses in cases of force majeure or pharmacy closure.
This distinction matters. A pharmacy cannot treat all stock transfers as ordinary commercial movements. The legal basis of the return, the identity of the recipient warehouse, the transaction document and the İTS record must be consistent. If a pharmacy returns a product to a different entity without a valid legal basis or without proper İTS notification, the transaction may create compliance risk.
Pharmacy-to-Pharmacy Exchange
Pharmacy-to-pharmacy exchange, known in Turkish practice as takas, is also regulated. Article 27 of the Regulation requires İTS notification for exchanges between pharmacies. The Regulation also states that pharmacy-to-pharmacy medicine exchange is not considered wholesale, but such exchange is permitted only between pharmacies operating within the same province.
This is a critical rule for pharmacies. A pharmacy may not use “exchange” as a disguised wholesale transaction. Nor may it freely transfer stock to pharmacies in other provinces. The transaction must have a lawful basis, must remain within the permitted framework and must be properly reflected in İTS.
The same-province limitation is especially important. If a pharmacy transfers medicine to another pharmacy outside the province and records it as an exchange, this may create both İTS inconsistency and a violation of pharmacy operation rules. Pharmacies should therefore use written internal controls for takas transactions and preserve supporting documents.
Expired and Deteriorated Medicines
Expired, deteriorated or unusable medicines are a major area of İTS compliance. Article 27 expressly requires İTS notification for destruction of expired or deteriorated medicines. In addition, Article 41 of the Regulation states that the pharmacy owner and responsible manager must regularly check expiry dates, remove expired or deteriorated medicines from sale, keep them in a separate area and apply to the provincial health directorate for destruction. The destruction process is documented with a report prepared together with the provincial health directorate official and chamber of pharmacists representative, and the report must be preserved at the pharmacy for presentation when requested.
This means that expired medicine compliance has three layers. First, the product must be physically removed from sale. Second, the legal destruction procedure must be followed. Third, the İTS record must reflect the destruction process correctly.
A pharmacy that only separates expired medicines but fails to complete the official destruction and İTS process remains exposed to risk. Likewise, a pharmacy that makes electronic changes without maintaining physical and documentary proof may have difficulty defending itself during an inspection.
Stock Reconciliation and İTS Stock Equalization
Stock reconciliation is one of the most practical challenges for pharmacies. Over time, discrepancies may arise between physical stock and İTS records due to software errors, incorrect notifications, returns not processed properly, damaged products, manual mistakes, old records, technical interruptions or operational negligence.
TİTCK-related announcements show that İTS stock consistency remains an active regulatory issue. In 2025, TİTCK announced a stock equalization process intended to align İTS records with physical stock and emphasized the importance of correcting discrepancies for both system integrity and legal obligations.
For pharmacies, the lesson is clear: stock reconciliation should not be delayed until an official equalization announcement or inspection. Regular internal checks should be performed monthly, and high-risk categories should be reviewed more frequently. These categories include controlled medicines, cold-chain products, expensive medicines, specialty drugs, imported medicines and products nearing expiry.
Revenue Declaration Through İTS
İTS is also connected to pharmacy revenue declaration obligations. Article 16 of the Regulation states that turnover information of private pharmacies is declared by the pharmacy owner and responsible pharmacist through İTS every April. If turnover information is not declared, access to İTS is temporarily blocked until the declaration is made.
TİTCK’s 27 April 2026 announcement, republished by the Turkish Pharmacists’ Association, stated that pharmacies must enter their 2025 VAT-excluded revenue information through the İTS revenue entry screen. The announcement further stated that, after 15 May 2026, pharmacies that had not entered revenue information would have their İTS access blocked until the information was entered, and that false or incorrect VAT-excluded revenue declarations could lead to necessary judicial and administrative proceedings.
This is a very important example of how İTS affects pharmacy operation beyond ordinary medicine movement. A pharmacy that loses İTS access may experience serious disruption in daily medicine transactions. Therefore, revenue declaration deadlines and accuracy should be treated as legal compliance matters, not only accounting issues.
Relationship Between İTS and Second Pharmacist Obligations
İTS revenue data may also affect staffing obligations. Article 16 of the Regulation requires second pharmacist employment where annual prescription count or annual turnover thresholds are exceeded. For turnover, the Regulation refers to VAT-excluded revenue reported to the institution. The same article states that pharmacies must declare turnover through İTS and that failure to declare may block İTS access.
This creates a direct legal connection between İTS data and the duty to employ second pharmacists. If a pharmacy exceeds the relevant revenue or prescription thresholds, it may be required to employ a second pharmacist. If the pharmacist fails to comply, the Regulation provides warning, time to comply and potential suspension of the pharmacy license.
Therefore, İTS compliance is not only about medicine traceability. It also affects workforce planning, professional supervision and pharmacy license risk.
İTS and Inspections
Pharmacies in Turkey are subject to inspection. The Regulation provides that pharmacy inspections are carried out by TİTCK health inspectors, pharmacists assigned by health directorates or other authorized professionals under the regulatory framework. Pharmacies are inspected at least twice per year and whenever necessary. During inspection, compliance with applicable legislation is evaluated according to the inspection form prepared by the institution.
İTS records are highly relevant during inspections. Inspectors may compare physical stock with electronic records, review expired medicine destruction, examine return transactions, analyze pharmacy-to-pharmacy exchanges, check whether sales were recorded electronically and assess whether required documents are preserved.
If deficiencies are found, the Regulation provides that the pharmacist may be given up to ten business days to correct them; if deficiencies remain, an additional warning period may be granted, and unresolved deficiencies may lead to legal action under the relevant statutory framework. If the same deficiency or non-compliance continues after sanction despite later inspection, the pharmacy license may be suspended until the deficiency is corrected.
İTS, Electronic Records and Evidence
İTS records are important evidence in pharmacy disputes. They may be relevant in administrative inspections, SGK reimbursement disputes, patient complaints, stock disputes, supplier disagreements, transfer transactions, inheritance or liquidation issues and criminal investigations involving counterfeit or illegally supplied medicines.
The Regulation requires all medicines sold in the pharmacy to be recorded electronically and requires those records to be preserved for inspection. This means that electronic records can either protect or harm the pharmacy depending on accuracy.
A pharmacy with consistent records can show that it purchased products lawfully, sold them properly, returned them to the correct party, exchanged them within legal limits and destroyed expired stock through lawful procedures. A pharmacy with inconsistent records may face allegations of unauthorized stock movement, improper sale, unrecorded destruction or negligence.
İTS and Online Medicine Sales Risk
The İTS compliance system also reinforces the broader prohibition on unauthorized digital medicine sales. The Regulation prohibits the sale of medicines and certain pharmacy-only products through the internet or any other electronic environment. It also prohibits opening websites in the name of pharmacy pharmacists or pharmacies.
This prohibition is connected to traceability. Medicines must move through lawful, controlled and traceable channels. Informal online sales, social media orders, marketplace listings or courier-based medicine supply outside the legal framework can undermine İTS traceability and create serious regulatory risk.
A pharmacy should ensure that its İTS records correspond to lawful pharmacy transactions, not unauthorized e-commerce activity. Digital communication should not be used to bypass prescription, patient counseling, İTS notification or medicine supply restrictions.
İTS and Wholesale Sale Prohibition
The Regulation states that pharmacies cannot sell medicines wholesale and cannot participate in tenders. It also states that pharmacy-to-pharmacy exchange is not considered wholesale, but may only be conducted between pharmacies operating in the same province.
İTS records may reveal suspicious bulk movements. If a pharmacy frequently transfers large quantities of medicines, returns products unusually, exchanges stock repeatedly or sells in patterns inconsistent with ordinary patient supply, these records may create inspection questions.
Pharmacies must therefore avoid using İTS as a technical cover for unlawful wholesale behavior. The legal nature of the transaction matters. A transaction that looks like wholesale activity may violate pharmacy law even if an electronic record exists.
İTS and Controlled Medicines
Controlled medicines, narcotic medicines, psychotropic medicines and other high-risk products require strict traceability. Although İTS applies broadly to human medicines, controlled medicines require additional caution because discrepancies may create serious legal consequences.
The pharmacy should apply enhanced controls for these medicines. Physical stock, prescription records, special prescription documents, electronic records and İTS entries should be reconciled regularly. Any discrepancy should be investigated immediately, documented and corrected through lawful procedures.
In practice, controlled medicine errors are more serious than ordinary stock differences. They may trigger health authority inspection, professional disciplinary action or criminal scrutiny depending on the facts.
İTS and Pharmacy Transfer or Closure
İTS compliance is also important when a pharmacy is transferred, relocated or closed. Article 27 includes returns to other warehouses in cases of force majeure or pharmacy closure among the İTS-notified transactions. Article 48 of the Regulation also provides that when a pharmacy is voluntarily closed, the provincial health directorate checks the operations performed on medicines and confirms that no medicines remain in the pharmacy before the license is cancelled.
This means that closure is not merely a commercial decision. Medicines must be legally handled before the pharmacy loses its status. Stock must be sold lawfully, returned, exchanged where permitted, destroyed if expired or transferred according to applicable rules. İTS must accurately reflect these movements.
In pharmacy transfers, the buyer and seller should also conduct İTS due diligence. The buyer should not assume that physical stock is clean unless İTS records, invoices, expiry status and transaction history are reviewed.
Common İTS Compliance Mistakes
The first common mistake is failing to reconcile physical stock with İTS stock regularly. A small discrepancy may become a major issue if ignored for months.
The second mistake is making return or exchange notifications without ensuring that the transaction document names the same buyer or recipient. Article 27 requires consistency between the İTS buyer and the buyer stated in the relevant document.
The third mistake is separating expired medicines physically but failing to complete the official destruction and İTS notification process.
The fourth mistake is treating pharmacy-to-pharmacy exchange as unrestricted stock transfer. The Regulation limits exchange to pharmacies operating in the same province.
The fifth mistake is ignoring annual İTS revenue declaration obligations. TİTCK’s 2026 announcement shows that failure to make the required declaration may block İTS access, and false or incorrect declarations may lead to administrative and judicial proceedings.
Legal Consequences of İTS Non-Compliance
İTS non-compliance may lead to multiple legal consequences. Depending on the issue, a pharmacy may face inspection findings, requests to correct deficiencies, administrative action, temporary İTS access restrictions, SGK reimbursement problems, professional disciplinary processes, product seizure, license suspension or further legal investigation.
The Regulation provides a structured inspection response mechanism: deficiencies may be notified, time may be given for correction, re-inspection may be conducted, and continuing deficiencies may lead to legal measures, including suspension of the pharmacy license where deficiencies remain unresolved despite sanctions.
The severity of consequences depends on the nature of the violation. A technical error corrected promptly may be treated differently from intentional false declaration, suspicious stock movement, unlawful wholesale activity, counterfeit medicine risk or repeated non-compliance.
Practical Compliance Checklist for Pharmacies
A pharmacy should build an İTS compliance checklist into daily operations.
First, every medicine purchase should be checked against invoice, physical product and İTS record. Second, every sale should be recorded electronically and reflected properly in İTS. Third, returns should be made only to legally appropriate warehouses and should match transaction documents. Fourth, pharmacy-to-pharmacy exchanges should be limited to lawful same-province transactions. Fifth, expired and deteriorated medicines should be separated, listed, reported for destruction and recorded in İTS. Sixth, revenue declarations should be made accurately and on time.
Seventh, physical stock should be reconciled with İTS regularly. Eighth, high-risk medicines should be checked more frequently. Ninth, staff should be trained on barcode scanning, notification errors, return procedures, exchange rules and destruction documentation. Tenth, all İTS-related supporting documents should be preserved for inspection.
İTS Compliance and Legal Risk Management
A legally careful pharmacy should treat İTS compliance as risk management. İTS records should be reviewed not only by staff but also by the responsible pharmacist. Large discrepancies, repeated corrections, unusual stock movements, high-value returns or unexplained missing products should be investigated immediately.
Pharmacies should prepare internal written procedures. These procedures may include medicine receipt, sale notification, return approval, expired product quarantine, destruction applications, stock reconciliation, İTS access management, revenue declaration and response to system errors.
Where an İTS error occurs, the pharmacy should document the problem, preserve screenshots or system messages, contact the appropriate support channel where necessary and correct the error through lawful means. Informal corrections without documentation may create later evidentiary problems.
Frequently Asked Questions
What is the Drug Tracking System in Turkey?
The Drug Tracking System in Turkey, or İTS, is the system operated by TİTCK to track medicines through notifications starting from production or importation and continuing through every movement point in the supply chain.
Are pharmacies required to use İTS?
Yes. Pharmacies must use İTS and make notifications for purchases, sales, returns, pharmacy-to-pharmacy exchanges and destruction of expired or deteriorated medicines.
What happens if İTS records and invoices do not match?
The Regulation requires consistency between the buyer shown in İTS notifications and the buyer shown in transaction documents. A mismatch may create inspection and compliance risk.
Does İTS apply to expired medicines?
Yes. Expired or deteriorated medicines must be removed from sale, separated, processed through the official destruction procedure and notified through İTS.
Can İTS access be blocked?
Yes. For example, the Regulation provides that if turnover information is not declared, İTS access may be temporarily blocked until declaration. TİTCK’s 2026 announcement also stated that pharmacies failing to enter 2025 VAT-excluded revenue information by 15 May 2026 would have İTS access blocked until entry.
Conclusion
The Drug Tracking System in Turkey is a cornerstone of pharmacy compliance. İTS ensures traceability, supports medicine safety, prevents irregular supply chain movements and provides electronic evidence for inspections and audits. For pharmacies, İTS is not merely a technical platform; it is a legal obligation that affects daily medicine purchase, sale, return, exchange, destruction, revenue declaration, stock reconciliation and inspection readiness.
The Regulation on Pharmacists and Pharmacies requires pharmacies to use İTS for human medicinal product movements, including purchase, sale, return, exchange and destruction of expired or deteriorated medicines. It also requires consistency between İTS records and transaction documents.
A pharmacy that fails to manage İTS properly may face serious consequences. These may include inspection findings, correction deadlines, administrative measures, temporary system access restrictions, SGK problems, license risks and legal proceedings in more serious cases. The 2026 TİTCK revenue declaration announcement shows that İTS access can be directly linked to compliance with pharmacy reporting obligations.
For pharmacists, the safest strategy is preventive İTS compliance. This requires regular stock reconciliation, accurate notifications, proper documentation, lawful return and exchange practices, timely destruction of expired products, correct revenue declarations and staff training. High-risk medicines should be controlled more frequently, and system errors should be documented carefully.
In Turkey, pharmacy operation is inseparable from digital traceability. A legally secure pharmacy must ensure that every medicine movement is not only physically correct but also electronically and legally traceable. İTS compliance is therefore one of the foundations of lawful, sustainable and safe pharmacy practice in Turkey.
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