Introduction
Expired medicines in Turkish pharmacy law are a highly important compliance issue because medicines are not ordinary retail products. A medicine that has passed its expiry date, deteriorated because of improper storage, lost stability, been damaged, or become unusable may create serious risks for patients, pharmacists and public health. For this reason, Turkish pharmacy legislation imposes strict duties on pharmacists regarding expiry-date control, removal from sale, separate storage, listing, official disposal, documentation, İlaç Takip Sistemi notifications and inspection readiness.
A pharmacy in Turkey is legally considered a healthcare institution. Law No. 6197 on Pharmacists and Pharmacies defines pharmacy as a healthcare service involving the preparation and supply of medicines, monitoring of pharmacological effect, safety, efficacy, cost, quality assurance, patient information and reporting of medicine-related problems. The law also states that opening and operating a pharmacy requires being a pharmacist.
This definition is central to the legal analysis. A pharmacist is not merely a commercial seller. The pharmacist is responsible for ensuring that medicines supplied to patients are safe, effective, properly stored, legally traceable and suitable for use. Therefore, expired medicine management is not a back-office inventory issue; it is a professional healthcare duty.
The main practical rule appears in Article 41 of the Regulation on Pharmacists and Pharmacies. This provision requires the pharmacy owner and responsible manager to regularly check expiry dates, remove expired or deteriorated medicines from sale, store them separately, list expired or unusable medicines, apply to the provincial health directorate for disposal, and keep the disposal report at the pharmacy for presentation when requested.
Meaning of Expired Medicines in Pharmacy Practice
An expired medicine is a product whose stated expiry date has passed. However, legal risk is not limited to medicines whose printed date has expired. A medicine may also become legally problematic if it is deteriorated, damaged, improperly stored, exposed to heat, humidity or freezing, recalled, opened in a way that affects safety, contaminated, or otherwise unusable.
The Regulation uses both concepts: medicines whose expiry date has passed and medicines that have deteriorated or become unusable. This is important because pharmacists must not focus only on the calendar date. A medicine may still be within its printed expiry date, but if cold-chain conditions were broken, if the packaging was damaged, if the product was exposed to water, or if there is suspicion of contamination, it may need to be removed from sale and processed as unusable.
From a legal perspective, the pharmacist’s duty is preventive. The pharmacy must not wait for patient harm or an official inspection before acting. Once a medicine is expired, deteriorated or unusable, it must be removed from sale and isolated from normal stock.
Legal Framework for Expired Medicines
The legal framework is primarily based on the Regulation on Pharmacists and Pharmacies and Law No. 6197 on Pharmacists and Pharmacies. The Regulation governs pharmacy services, medicine tracking, medicine storage, expired medicines, inspection and closure procedures. It states that its purpose is to determine pharmacists’ duties, powers and responsibilities and regulate pharmacy opening, operation, relocation, transfer, closure and pharmacy services.
Article 27 of the Regulation is also essential. It requires pharmacies to use the medicine tracking system for transactions involving human medicines, including purchase, sale, returns, pharmacy-to-pharmacy exchange and destruction of expired or deteriorated medicines. In other words, destruction is not only a physical act; it must be reflected through İTS notification.
Article 41 is the main article on expired medicines. It expressly states that the pharmacy owner and responsible manager must regularly check medicine expiry dates, remove deteriorated and expired medicines from sale, and keep them in a separate area. It also provides that expired or unusable medicines must be listed and that the pharmacist must apply to the provincial health directorate for their destruction. The destruction is carried out or arranged under a report prepared together with the provincial health directorate official and chamber of pharmacists representative, and the matter is notified to the tax office. The report must be preserved at the pharmacy for presentation when requested.
Regular Expiry-Date Control
The first legal duty is regular control. A pharmacist cannot defend expired stock by saying that the expiry date was not noticed. Article 41 places an active control obligation on the pharmacy owner and responsible manager.
A legally compliant pharmacy should therefore create an expiry-date monitoring system. This system should include periodic shelf checks, stock software alerts, manual review of high-risk products, near-expiry lists, separation of unsaleable products and documented internal controls.
The frequency of checks should depend on the pharmacy’s stock profile. High-volume pharmacies, hospital-adjacent pharmacies, pharmacies with high SGK turnover, pharmacies dispensing biological products, cold-chain medicines or controlled medicines should conduct more frequent checks. Products with short shelf life should be monitored closely.
The pharmacist should also train employees. Pharmacy staff may receive stock, place products on shelves and assist with sales. If employees are not trained to detect expired products, the pharmacist may still remain responsible because employees operate under the pharmacist’s supervision.
Removal from Sale
Once a medicine is expired, deteriorated or unusable, it must be removed from sale. This is not optional. Article 41 requires the pharmacy owner and responsible manager to remove deteriorated and expired medicines from sale and store them separately.
Removal from sale must be real and physical. It is not enough to mark the product in software while leaving it on ordinary shelves. An expired product kept among saleable stock creates a serious inspection risk. It may be accidentally dispensed to a patient. It may also suggest that the pharmacy lacks proper internal control.
The safest practice is to create a clearly marked quarantine area. This area should be physically separate from saleable stock and should be inaccessible to ordinary customer service activity. The products should be labeled as expired, deteriorated, unusable, pending destruction or pending official procedure.
Separate Storage of Expired Medicines
Separate storage is expressly required by Article 41. The purpose is to prevent accidental sale, misuse, confusion and unauthorized handling.
The separate area should be organized and documented. Products should not be mixed randomly. They should be listed by product name, barcode, quantity, batch or serial information where relevant, expiry date and reason for removal. Controlled medicines, cold-chain products and high-cost medicines should be identified separately because they may require enhanced handling.
The separate storage area should not be accessible to patients. It should also not create confusion with returned products, recalled products or saleable stock. If the pharmacy keeps multiple categories of non-saleable products, each category should be clearly separated: expired products, recalled products, damaged products, products pending return, products pending destruction and controlled products pending official action.
Listing Expired and Unusable Medicines
Article 41 requires expired or unusable medicines to be listed by the pharmacy owner or responsible manager before applying for destruction. This list is a crucial legal document.
The list should be complete, accurate and compatible with İTS records. A poor or incomplete list may create problems during official destruction, tax notification, inspection or later dispute. The list should ideally include:
Product name,
Barcode or identification number,
Quantity,
Batch or serial number where applicable,
Expiry date,
Reason for destruction,
Storage condition issue if applicable,
Whether the product is controlled or cold-chain,
Date of removal from sale,
İTS status.
The pharmacist should preserve a copy of the list. If the destruction report later refers to the list, the two documents should match. Any difference between the physical products, destruction list, İTS records and tax notification may create compliance risk.
Application to the Provincial Health Directorate
The next step is applying to the provincial health directorate for destruction. Article 41 states that the pharmacy owner or responsible manager applies to the provincial health directorate for destruction of expired or unusable medicines.
This rule is important because pharmacies cannot simply dispose of expired medicines independently. Throwing medicines into ordinary waste, giving them to unauthorized persons, returning them informally, selling them at a discount, donating them or destroying them without official procedure may violate pharmacy law, environmental principles, tax documentation and medicine traceability rules.
The application should be made in writing and should attach the product list. The pharmacist should keep proof of application. If there is delay by the authority, the pharmacy should continue to store the products separately and safely until the procedure is completed.
Official Destruction Report
The Regulation requires that destruction be documented by a report prepared together with the provincial health directorate official and the chamber of pharmacists representative. The destruction is then carried out or arranged according to the relevant legislation, and the situation is notified to the tax office. The report must be kept at the pharmacy for presentation when requested.
This report is the key evidence that expired medicines were lawfully removed from the pharmacy system. It protects the pharmacist against later allegations that the products were sold, lost, unlawfully transferred or disposed of improperly.
The report should match the destruction list and İTS records. If any product is missing, added, substituted or recorded incorrectly, the discrepancy should be explained and documented immediately. The pharmacist should never sign an inaccurate report casually.
Tax Office Notification
Article 41 expressly provides that the matter is notified to the tax office after the destruction process. This shows that expired medicine disposal has a financial and accounting dimension as well as a health law dimension.
Medicines are commercial inventory. Destroying inventory affects accounting records, tax calculations and stock value. Therefore, the pharmacist should coordinate with the accountant before and after destruction. The destruction report may be necessary to justify inventory loss, remove stock from accounting records and support tax treatment.
A pharmacy should not treat destruction only as a health authority procedure. The tax documentation should be consistent with stock records, invoices, İTS notifications and the official destruction report.
İTS Notification for Expired Medicine Destruction
Article 27 requires pharmacies to use the medicine tracking system and make notifications for destruction of expired or deteriorated human medicines.
This requirement is central to modern pharmacy compliance. İTS creates electronic traceability of medicine movements. If a medicine is destroyed physically but remains active in İTS stock, a mismatch may appear. If a product is removed from İTS without a proper destruction report, authorities may ask what happened to the product.
The pharmacist should therefore align the physical process, official report and İTS notification. This is especially important for high-cost products, SGK-reimbursed medicines, cold-chain medicines, controlled medicines and products subject to recall.
A pharmacy should conduct a final reconciliation after destruction. Physical stock, destruction list, destruction report, İTS notification and accounting records should all be consistent.
Difference Between Expired Medicines, Recalled Medicines and Damaged Medicines
Pharmacies should distinguish between different categories of non-saleable products.
Expired medicines are products whose expiry date has passed. Deteriorated medicines are products that have become unusable because of storage failure, physical damage, contamination, cold-chain breach or similar reasons. Recalled medicines are products removed from the market because of a regulatory decision, product defect, safety concern or quality issue. Damaged medicines may include products with broken packaging, leaking bottles, crushed blister packs or compromised seals.
These categories may overlap. A recalled product may also be expired. A damaged product may also be deteriorated. But the procedure may differ depending on the cause. Recalled products may require compliance with TİTCK recall instructions. Expired and deteriorated products require Article 41 destruction procedure and İTS notification. Products returned to warehouses may require İTS return notification and proper documentation.
The pharmacist should classify products carefully before choosing the legal route.
Expired Cold-Chain Medicines
Cold-chain medicines create special risks. A cold-chain product may expire by date, but it may also become unusable before expiry if it is exposed to unsuitable temperature. The Regulation requires medicines subject to special storage conditions or cold chain to be accepted, stored and supplied to patients under their required storage conditions, and requires pharmacies to keep a refrigerator for cold-chain medicines. It also requires regular temperature and humidity records, early warning systems, retrospective memory thermometers and calibration of required devices.
If a cold-chain medicine expires or becomes unusable because of temperature deviation, the pharmacy should separate it immediately, document the reason and follow the required destruction procedure. The pharmacist should preserve temperature logs and deviation records because they may explain why the product became unusable.
Cold-chain expired stock can be financially significant. Some biological medicines, insulin products, vaccines and specialty medicines are expensive. However, financial loss does not justify keeping them in saleable stock or supplying them to patients.
Expired Controlled Medicines
Controlled, narcotic or psychotropic medicines require enhanced care. If such products expire or become unusable, the pharmacist should not handle them like ordinary expired stock. They should be separated securely, listed accurately and processed with strict documentation.
Controlled medicines carry diversion and criminal-law risk. A missing expired controlled medicine may create serious suspicion. Therefore, physical stock, prescription records, colored prescription system records, İTS records and destruction documentation should be reconciled carefully.
Only authorized persons should access controlled expired stock. The pharmacist should personally supervise the process. Any discrepancy should be documented and reported through the proper route.
Expired Medicines During Pharmacy Closure
Expired medicine management is also critical during pharmacy closure. Article 48 of the Regulation provides that when a pharmacist voluntarily closes a pharmacy, the provincial health directorate checks the procedures applied to medicines, verifies that no medicines remain, ensures removal of pharmacy signs, records loss of pharmacy status and cancels the license.
This means a closing pharmacy cannot leave expired medicines behind. Before license cancellation, all medicines must be lawfully sold, returned, transferred, exchanged, destroyed or otherwise processed according to law. Expired and deteriorated products must be listed and destroyed under Article 41 procedure, with İTS notification.
Failure to handle expired stock before closure may delay license cancellation and create post-closure liability.
Inspection of Expired Medicines
Pharmacies in Turkey are subject to regular inspection. The Regulation provides that pharmacies are inspected at least twice per year and whenever necessary; inspectors determine whether the pharmacy complies with current legislation according to the official inspection form. If deficiencies are detected, the pharmacist may be given up to ten business days to remedy them, followed by an additional warning period if deficiencies remain. If they are still not remedied, action is taken under Law No. 6197.
Expired medicines are a likely inspection topic. Inspectors may review shelves, refrigerators, storage rooms, quarantine areas, destruction reports, İTS records, temperature logs and medicine stock. They may check whether expired products are mixed with saleable stock, whether separate storage exists, whether destruction applications were made and whether reports are preserved.
The Regulation also provides that if deficiencies or violations detected in the pharmacy are not remedied despite sanctions and are found again in a subsequent inspection, the license may be suspended until the deficiency is corrected.
Electronic Records and Expired Medicines
Article 45 of the Regulation requires all medicines sold in the pharmacy to be recorded electronically and requires those records to be preserved for presentation during inspections. It also requires pharmacies to keep inspection, personnel and intern registers.
Electronic records matter for expired medicine cases because they show whether a product was sold, returned, destroyed, exchanged or still in stock. If an expired medicine was supposedly removed but the electronic system shows it as saleable, the pharmacy may face questions. If İTS records show destruction but no official report exists, the pharmacist may face another kind of evidentiary problem.
A pharmacy should therefore integrate expiry control with electronic record management. Expired stock should be blocked in pharmacy software, removed physically, listed, processed officially and updated in İTS.
Administrative Liability
Administrative liability may arise if expired or deteriorated medicines are found in saleable stock, if the pharmacy fails to check expiry dates, if expired products are not separated, if destruction procedure is not followed, if İTS notification is missing, or if inspection deficiencies are not corrected.
Law No. 6197 contains general administrative penalty provisions for violations of statutory prohibitions and obligations where the conduct is not a crime and no special provision applies. It also provides specific rules for repeated violations and certain product-related violations in the current consolidated text.
The exact sanction depends on the facts. A single expired product immediately separated and documented may be evaluated differently from large-scale expired stock found on sale shelves. Repeated violations, controlled medicines, patient harm, false records or failure to comply with inspection warnings may lead to more serious consequences.
Civil Liability
Civil liability may arise if a patient suffers harm because an expired or deteriorated medicine is supplied. The patient may claim compensation for medical expenses, treatment failure, additional harm, loss of income or moral damages depending on the circumstances.
Causation will be important. The patient must generally show that the pharmacy supplied an expired or unusable medicine and that this caused harm. However, if the medicine was clearly expired and the pharmacy’s records are weak, the pharmacist’s defense becomes difficult.
Even if no physical harm occurs, a patient complaint may trigger inspection, professional disciplinary review and reputational damage. Therefore, the pharmacy’s safest strategy is strict prevention.
Criminal Liability Risks
Most expired medicine issues are administrative or civil in nature. However, criminal risk may arise in serious cases. For example, knowingly supplying expired or deteriorated medicines, falsifying records, selling products that are unsafe, handling controlled medicines unlawfully, or causing serious patient injury may trigger criminal-law questions depending on the facts.
Criminal liability depends on the nature of the medicine, the pharmacist’s knowledge and fault, the harm caused, whether records were falsified and whether the conduct falls within a criminal provision. A pharmacist facing such allegations should not give informal explanations without legal review.
Professional Disciplinary Liability
Expired medicine violations may also create professional disciplinary risk. Pharmacy is a trusted healthcare profession. Keeping expired medicines among saleable stock, ignoring destruction duties, failing to supervise staff or repeatedly violating inspection warnings may be viewed as conduct inconsistent with professional responsibility.
Professional disciplinary review may be separate from administrative penalties or civil claims. A single event may therefore produce multiple proceedings: health authority inspection, SGK review, patient complaint, civil claim and professional disciplinary process.
SGK Reimbursement Risks
Expired medicines may also create SGK-related problems. If an expired medicine is supplied under an SGK-covered prescription, SGK may question reimbursement, patient delivery, stock records and prescription compliance. A later audit may compare MEDULA records, İTS records, pharmacy stock and invoice data.
If the pharmacy destroyed products but failed to update İTS, SGK or other authorities may see inconsistent stock. If a high-cost medicine appears sold but the pharmacy cannot prove lawful supply, financial and legal disputes may arise.
For SGK-covered high-cost medicines, expiry control is especially important. The financial loss from expiry may be significant, but unlawful supply or false recording creates greater risk.
Environmental and Public Health Considerations
Expired medicine disposal is also an environmental and public health issue. Medicines should not be thrown into ordinary trash, sinks or toilets. Improper disposal may contaminate water, soil or waste systems, create accidental poisoning risk, or allow unauthorized persons to collect and misuse medicines.
The official disposal procedure protects not only the pharmacy but also society. Article 41 requires destruction to be carried out or arranged under official documentation and relevant legislation.
Pharmacists should also educate patients about not using expired medicines and not disposing of medicines improperly. The pharmacist’s professional role includes creating awareness about medicine use, storage and disposal risks.
Practical Internal Compliance System
A legally careful pharmacy should build an internal system for expired medicines.
First, every product should be entered into stock with expiry information where possible. Second, shelves should be organized according to first-expiry-first-out principles. Third, near-expiry products should be flagged before expiry. Fourth, staff should conduct regular shelf and refrigerator checks. Fifth, expired or suspect products should be removed immediately. Sixth, non-saleable stock should be stored separately. Seventh, the pharmacist should prepare an official list. Eighth, application should be made to the provincial health directorate. Ninth, destruction should be documented. Tenth, İTS and accounting records should be updated.
This system should be written, not merely remembered. Written procedures help employees act correctly and help the pharmacist prove compliance during inspection.
Practical Checklist for Expired Medicines
A pharmacy should apply the following checklist:
Regularly check expiry dates.
Monitor cold-chain and short-expiry products more frequently.
Remove expired, damaged or deteriorated products from sale immediately.
Store non-saleable products in a separate, marked area.
Prepare a complete list of products to be destroyed.
Apply to the provincial health directorate for destruction.
Ensure participation of the provincial health directorate official and chamber representative.
Obtain and preserve the destruction report.
Notify the tax office as required.
Make İTS destruction notifications.
Update accounting records.
Preserve documents for inspection.
Train staff on expiry control.
Investigate stock discrepancies immediately.
Common Mistakes
The first common mistake is leaving expired products on ordinary shelves. Even if the pharmacist did not intend to sell them, this creates inspection and accidental-sale risk.
The second mistake is separating expired medicines physically but failing to apply for official destruction.
The third mistake is destroying medicines informally without provincial health directorate procedure.
The fourth mistake is failing to update İTS after destruction.
The fifth mistake is failing to preserve destruction reports.
The sixth mistake is ignoring cold-chain deviations before expiry.
The seventh mistake is treating controlled expired medicines like ordinary stock.
The eighth mistake is failing to coordinate with the accountant regarding tax notification and inventory records.
Frequently Asked Questions
What must a pharmacy do with expired medicines in Turkey?
The pharmacy owner and responsible manager must regularly check expiry dates, remove expired or deteriorated medicines from sale, store them separately, list expired or unusable medicines and apply to the provincial health directorate for their destruction.
Can expired medicines be thrown away by the pharmacy?
No. Expired or unusable medicines must be processed through the official destruction procedure. The destruction is documented with the provincial health directorate official and chamber of pharmacists representative, and the report must be kept at the pharmacy.
Is İTS notification required for expired medicine destruction?
Yes. Pharmacies must use the medicine tracking system and make notifications for destruction of expired or deteriorated human medicines.
Are pharmacies inspected for expired medicines?
Yes. Pharmacies are inspected at least twice per year and whenever necessary. Inspectors check compliance with legislation under the official inspection form, and deficiencies may lead to correction periods and further legal action.
Can a pharmacist be liable if an expired medicine is sold?
Yes. Selling or supplying expired medicine may create administrative liability, civil compensation risk, professional disciplinary liability and, in serious cases involving patient harm or intentional conduct, possible criminal-law exposure.
Conclusion
Expired medicines in Turkish pharmacy law are subject to strict professional and legal control. A pharmacist must not allow expired, deteriorated or unusable medicines to remain in ordinary saleable stock. The pharmacy owner and responsible manager must regularly check expiry dates, remove expired and deteriorated products from sale, keep them separately, list them, apply to the provincial health directorate for destruction and preserve the official destruction report.
The process also has a digital compliance dimension. Pharmacies must use İTS and make notifications for destruction of expired or deteriorated human medicines. The physical stock, destruction list, official report, İTS notification and accounting records must be consistent.
Expired medicine compliance is also closely connected to inspections. Pharmacies are inspected at least twice per year, and deficiencies detected during inspection may lead to correction periods, warnings, legal action and, if unresolved despite sanctions, license suspension until the deficiency is corrected.
For pharmacists, the safest legal approach is preventive control. Expiry-date monitoring should be part of daily pharmacy management. Staff should be trained, near-expiry stock should be flagged, cold-chain deviations should be documented, controlled medicines should be handled separately and official disposal procedures should be completed without delay.
In Turkey, expired medicine management is not merely an inventory loss issue. It is a patient safety obligation, an environmental responsibility, an İTS compliance duty, an inspection priority and a potential liability area. A legally compliant pharmacy protects patients, public health and the pharmacist’s professional security by ensuring that expired and deteriorated medicines are never supplied and are always disposed of through the proper legal procedure.
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