Bausch + Lomb colleagues have a responsibility to patients and the healthcare community to properly handle and distribute Drug Samples, Evaluation Products, and HCP-dispensed products. Business plans involving sample evaluations or demonstration products must be reviewed by the Compliance Department. Distribution of drug samples, evaluation products (Demonstration Products), and HCP-dispensed product samples should be made in reasonable quantities, considering the size and patient population of the practice or the consumers of the HCP-dispensed product. Additionally, colleagues should adhere to guidance specific to their products or business units, as some may be subject to additional guidelines related to particular products or business areas.
Bausch + Lomb colleagues have a responsibility to patients and the healthcare community to properly handle and distribute Drug Samples, Evaluation Products, and HCP-dispensed products. Business plans involving sample evaluations or demonstration products must be reviewed by the Compliance Department. Distribution of drug samples, evaluation products (Demonstration Products), and HCP-dispensed product samples should be made in reasonable quantities, considering the size and patient population of the practice or the consumers of the HCP-dispensed product. Additionally, colleagues should adhere to guidance specific to their products or business units, as some may be subject to additional guidelines related to particular products or business areas.
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Drug samples and evaluation products are intended to help healthcare professionals become familiar with the safety and effectiveness of our products, as well as to assist patients in starting treatment or becoming acquainted with the medication. These drug samples, evaluation products, demonstration items, and HCP-dispensed products should be provided to patients by healthcare professionals free of charge. Additionally, Bausch + Lomb may not encourage, nor may healthcare professionals directly request, reimbursement from government agencies or any third-party payers for these products.
The same policy applies to HCP-dispensed products provided by Bausch + Lomb colleagues to healthcare professionals or directly to consumers. Drug samples, evaluation products, demonstration items, and HCP-dispensed products may not be used to offer discounts.
Sales colleagues may ask healthcare professionals if they require drug samples, but these samples should only be distributed upon request to licensed HCPs, in compliance with the PDMA, local laws, regulations, and industry codes of practice.
Drug samples and evaluation products are intended to help healthcare professionals become familiar with the safety and effectiveness of our products, as well as to assist patients in starting treatment or becoming acquainted with the medication. These drug samples, evaluation products, demonstration items, and HCP-dispensed products should be provided to patients by healthcare professionals free of charge. Additionally, Bausch + Lomb may not encourage, nor may healthcare professionals directly request, reimbursement from government agencies or any third-party payers for these products.
The same policy applies to HCP-dispensed products provided by Bausch + Lomb colleagues to healthcare professionals or directly to consumers. Drug samples, evaluation products, demonstration items, and HCP-dispensed products may not be used to offer discounts.
Sales colleagues may ask healthcare professionals if they require drug samples, but these samples should only be distributed upon request to licensed HCPs, in compliance with the PDMA, local laws, regulations, and industry codes of practice.
Sales colleagues should not remove, alter or manipulate Bausch + Lomb Drug Samples, Evaluation Products, Demonstration Products or HCP dispensed products or those belonging to another company. Colleagues may never provide Drug Samples, Evaluation Products, Demonstration Products or HCP dispensed products in exchange for an HCP's purchase, prescription or recommendation of Bausch + Lomb products, or to reward an HCP for doing so. This includes providing Drug Samples, HCP dispensed products or devices as a reward for prescribing or purchasing another product. Additionally, the distribution of Drug Samples, Evaluation Products, and Demonstration Products or HCP dispensed products may not be tied to prescription activity or as a mechanism to circumvent government price reporting. Drug Samples, Evaluation Products and HCP dispensed products may not be provided for an HCP's personal use.
When drug samples are provided directly to a healthcare professional by a sales colleague, the licensed HCP must sign and date a receipt at the time of distribution. This signature should be visually confirmed by the sales colleague authorized to distribute the samples.
When Drug Samples are distributed directly from Bausch + Lomb or a corporately controlled Third Party Vendor, the licensed HCP should provide all the necessary documentation to prove their identity and need for the Drug Samples as required by Bausch + Lomb’s Sample Accountability Policy and Procedure Guide.
Healthcare professionals must be given documentation and disclosure confirming that Drug Samples, Evaluation Products, Demonstration Products, and HCP-dispensed products are provided at no charge. It is illegal to sell, purchase, trade, or offer to sell, purchase, or trade any of these products. If any Bausch + Lomb colleague becomes aware that a Drug Sample, Evaluation Product, Demonstration Product, or HCP-dispensed product has been sold, purchased, traded, or billed, they must immediately report this to the Compliance Department.
Evaluation Products may be provided free of charge to healthcare professionals to help them assess the product’s appropriate use and functionality, and to determine if, when, and how to use, order, purchase, or recommend the product in the future. These products should not be offered to induce prescribing and are generally intended for use in patient care. Evaluation Products include both single-use and multiple-use items.
Evaluation Products may be provided free of charge to healthcare professionals to help them assess the product’s appropriate use and functionality, and to determine if, when, and how to use, order, purchase, or recommend the product in the future. These products should not be offered to induce prescribing and are generally intended for use in patient care. Evaluation Products include both single-use and multiple-use items.
Demonstration Products are usually unsterilized single-use items or mock-ups used for healthcare professional and patient education and awareness. For example, a healthcare professional might use a Demonstration Product to show a patient the type of device planned for implantation. Demonstration Products are typically not intended for patient care. They are usually labeled with disclaimers such as “not intended for patient use,” “Not for Human Use,” or similar designations on the product, packaging, or accompanying documentation.
Demonstration Products are usually unsterilized single-use items or mock-ups used for healthcare professional and patient education and awareness. For example, a healthcare professional might use a Demonstration Product to show a patient the type of device planned for implantation. Demonstration Products are typically not intended for patient care. They are usually labeled with disclaimers such as “not intended for patient use,” “Not for Human Use,” or similar designations on the product, packaging, or accompanying documentation.
Pharmaceutical drug and medical device samples must not be distributed to:
Pharmaceutical drug and medical device samples must not be distributed to:
Samples may only be provided to licensed prescribers expected to treat patients within the approved indication and patient population. This includes HCPs who are permitted by state law to provide the relevant treatment. State laws dictate licensure requirements for appropriate recipients of samples.
HCP-dispensed Bausch + Lomb products, such as pharmaceutical medications permitted for dispensing by physicians in certain states, and non-prescription cosmetic skincare products, are sold by Bausch + Lomb to healthcare professionals for resale to customers and consumers benefiting from their proper use in accordance with Bausch + Lomb guidelines. These products must never be offered to induce prescribing or encourage inappropriate use as a substitute for product discounts.
HCP-dispensed Bausch + Lomb products, such as pharmaceutical medications permitted for dispensing by physicians in certain states, and non-prescription cosmetic skincare products, are sold by Bausch + Lomb to healthcare professionals for resale to customers and consumers benefiting from their proper use in accordance with Bausch + Lomb guidelines. These products must never be offered to induce prescribing or encourage inappropriate use as a substitute for product discounts.
All drug samples and evaluation products should be provided with the intention that the healthcare professional will use them according to Bausch + Lomb’s approved product labeling, PMA, or 510(k) clearance. Drug samples, evaluation products, demonstration products, and HCP-dispensed products must be distributed following established sampling program guidelines. Any new or modified sampling program, including protocols regarding the free provision of evaluation products for medical devices, must receive prior approval from the Compliance and Legal Departments before implementation or the effective date.
All drug samples and evaluation products should be provided with the intention that the healthcare professional will use them according to Bausch + Lomb’s approved product labeling, PMA, or 510(k) clearance. Drug samples, evaluation products, demonstration products, and HCP-dispensed products must be distributed following established sampling program guidelines. Any new or modified sampling program, including protocols regarding the free provision of evaluation products for medical devices, must receive prior approval from the Compliance and Legal Departments before implementation or the effective date.
Drug samples, evaluation products, demonstration products, and HCP-dispensed products must be stored under conditions that preserve their stability, integrity, and effectiveness. Sales colleagues must ensure these products remain free from contamination or damage before distribution to healthcare professionals. Samples should never be stored on the floor where they risk exposure to moisture, crushing, or other harm. Maintaining sterility and functional condition is essential. If contamination or deterioration is discovered at any time, the sales colleague should immediately cease use and return the product.
Sales colleagues must keep accurate records of all drug samples, evaluation products, demonstration products, and HCP-dispensed products and follow established sample accountability procedures. Expired drug samples, evaluation products, and HCP-dispensed products should be returned for proper disposal and must not be distributed to healthcare professionals. Additionally, products nearing expiration within the current calendar month should not be distributed. For more detailed information, refer to Bausch + Lomb’s Sample Accountability Policy and Procedure Guide and the Field Sales Drug Sampling Policy and Procedures Guide. Any loss or theft of samples, evaluation, demonstration, or HCP-dispensed products must be reported immediately to the Sample Accountability Department or designated representative.
Drug samples, evaluation products, demonstration products, and HCP-dispensed products must be stored under conditions that preserve their stability, integrity, and effectiveness. Sales colleagues must ensure these products remain free from contamination or damage before distribution to healthcare professionals. Samples should never be stored on the floor where they risk exposure to moisture, crushing, or other harm. Maintaining sterility and functional condition is essential. If contamination or deterioration is discovered at any time, the sales colleague should immediately cease use and return the product.
Sales colleagues must keep accurate records of all drug samples, evaluation products, demonstration products, and HCP-dispensed products and follow established sample accountability procedures. Expired drug samples, evaluation products, and HCP-dispensed products should be returned for proper disposal and must not be distributed to healthcare professionals. Additionally, products nearing expiration within the current calendar month should not be distributed. For more detailed information, refer to Bausch + Lomb’s Sample Accountability Policy and Procedure Guide and the Field Sales Drug Sampling Policy and Procedures Guide. Any loss or theft of samples, evaluation, demonstration, or HCP-dispensed products must be reported immediately to the Sample Accountability Department or designated representative.
The quantity or value of drug samples, HCP-dispensed products, and evaluation products may be subject to disclosure under federal and state laws. Bausch + Lomb complies by disclosing the identity and quantity of prescription drug samples requested and distributed to each prescriber in accordance with applicable legal requirements.
Keep in Mind: For complete sampling policies and procedures, refer to Bausch + Lomb’s sample accountability policies and procedures.
The quantity or value of drug samples, HCP-dispensed products, and evaluation products may be subject to disclosure under federal and state laws. Bausch + Lomb complies by disclosing the identity and quantity of prescription drug samples requested and distributed to each prescriber in accordance with applicable legal requirements.
Keep in Mind: For complete sampling policies and procedures, refer to Bausch + Lomb’s sample accountability policies and procedures.
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