Committed To Product Security & Patient Safety

We make medicines for some of the world’s most serious and life-threatening diseases, and protecting patient safety at each step of the supply chain is critical. We are committed to ensuring people can safely access our medicines when they need them.

Illegitimate Medicines Threaten Public Health

Illegitimate medicines – medicines that may be counterfeit, adulterated, diverted or illegally imported - continue to pose a significant global threat to patient safety. These medicines are neither safe nor effective and have significant negative implications for public health. Several factors, such as technological advancements, globalization and the Internet, have enabled counterfeiters to more easily manufacture counterfeit goods and introduce illegitimate medicines into the supply chain.

How We’re Fighting Illegitimate Medicines

Genentech employs several strategies to combat the global threat of illegitimate medicines, and we continuously assess and enhance our product security strategies to ensure patients do not receive unsafe medicines. These strategies include:

• Using special packaging and printing techniques, including serializing our products, to make illegitimate products harder to make and easier to detect
• Closely monitoring the Internet to identify and take action against suspicious product sources
• Working with government and law enforcement to develop stronger pharmaceutical crime laws
• Supporting government agencies in identifying and prosecuting sources of illegitimate medicines
• Working closely with suppliers and customers to secure our distribution channels

Serialization for Supply Chain Security

One of the strategies Genentech has been working on implementing to combat illegitimate medicines is Serialization. Serialization is the inclusion of unique product identifying serial numbers on our products and is being mandated industry-wide by the US Drug Supply Chain Security Act (DSCSA). We believe serialization is a core security technology that will further protect our patients, products and company reputation by supporting the prevention of illegitimate drugs being introduced into the U.S. supply chain.

The DSCSA was enacted by Congress in November 2013 to enhance the ability of the U.S. Food and Drug Administration (FDA) to protect consumers from drugs that may be counterfeited, stolen, contaminated or otherwise harmful. The DSCSA implementation will be phased in over a 10-year period (2013-2023) with successive requirements for manufacturers, wholesalers/distributors and dispensers.

Genentech is taking all necessary steps, including partnering with key stakeholders across the Pharmaceutical industry, for successful and timely implementation of DSCSA milestones.

What You Can Do to Protect Yourself or Your Patients

For Healthcare Professionals

• Be wary of new or unfamiliar distributors that offer products at substantially lower prices.
• Always purchase medicines from legitimate distributors that are licensed to operate within the United States. Many of our medicines require special storage and handling, so they are only available from specific authorized distributors. View the Genentech's Authorized Distributor Directory.
• Familiarize yourself with the medications you prescribe or dispense to patients, paying specific attention to the presence of altered or unsealed containers or changes in the packaging of the medicine.
• Ensure that external packaging, product labeling and product inserts are in US English and that a National Drug Code (NDC) number is included. Products that have non-U.S. labels or those that do not have a National Drug Code (NDC) number are likely to be counterfeits or illegal imports.

For Your Patients

Advise patients to:

• Be cautious when purchasing medicine online. Always purchase medicines from legitimate pharmacies that are licensed to operate within the United States. Visit FDA BeSafeRx or call 1-888-463-6332 to make sure you are using a safe, legal online pharmacy.
• Ensure that external packaging, product labeling and product inserts are in US English and that a National Drug Code (NDC) number is included. Products that have non-U.S. labels or those that do not have a National Drug Code (NDC) number are likely to be counterfeits or illegal imports.
• Pay specific attention to the presence of altered or unsealed containers or changes in the packaging of the product. Bring any differences in the physical appearance or taste of the medicine, or any unexpected side effects to the attention of your healthcare provider and the FDA (1-800-FDA-1088).