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FDA Announces Deadline Delay in Drug Supply Chain Integrity Act (DSCSA)

FDA Announces Deadline Delay in Drug Supply Chain Integrity Act (DSCSA)

Drug Supply Chain Integrity Act (DSCSA):

The FDA announced yesterday that it has delayed taking any action regarding dispensing pharmacies in relation to the Drug Supply Chain Integrity Act (DSCSA) deadline that had been scheduled to go into effect on July 1st, 2015. What is now being called the “Track and Trace” enforcement of the Drug Supply Chain Integrity Act has been delayed until a new November 1st, 2015 deadline. In a new guidance document released yesterday, the FDA has basically given pharmacies another four months to get into compliance with the new requirements. Be advised that along with the announced delay was a “warning” from the FDA that there will be no more delays and all requirements must still be met under the law for pharmacies to be in compliance by the new deadline. It must also be noted that the newly released guidance does not extend the July 1 deadline for the requirement that pharmacists must provide this product tracing information to a subsequent owner, which includes pharmacy-to-pharmacy transfers, except for a specific patient need. The FDA further clarifies in its guidance that “if a dispenser has not received product tracing information prior to or at the time it takes ownership of a product, FDA recommends that the dispenser work with the previous owner to receive this information.” It is further noted that a “subsequent owner” does not include a patient.

As previously stated, pharmacies will be required to collect and keep records of what is being dubbed the “3T” information (Transaction History, Transaction Statement, and Transaction Information) for each prescription drug it purchases on or after the new November 1st deadline. It is also important to note that covered pharmacies must also have systems in place to segregate and investigate any drugs purchased or received after the deadline. This part of the law is specifically aimed at the compounding and specialty pharmacies that have been at the center of national attention since concerns about the safety of compounding pharmacies were raised after a 2012 outbreak of fungal meningitis tied to a compounding pharmacy in Massachusetts.

Some other aspects of the DSCSA to consider include:
– When ownership of a pharmacy changes, or the prescription files are transferred to another pharmacy, the pharmacy will need to provide the 3T information to the new owner or pharmacy receiving the transferred prescription files.
– Product returns also are addressed in the DSCSA law. In this respect, pharmacies cannot view the DSCSA as only requiring the passive receipt of information from suppliers or manufacturers.
– Records and information will need to be retained for at least 6 years, so pharmacies also need to deal with this additional and significant record-keeping responsibility.

This law applies to almost every pharmacy in the country. The only exclusions are licensed health care practitioners (such as physicians) who dispense medication as part of their medical practice.

Any pharmacy that has not yet begun considering the impact of the DSCSA on its business should do so immediately. Pharmacies that do not currently have systems in place to ensure compliance with the laws requirements should take steps to develop appropriate policies and procedures, train their pharmacists on the new systems, and be prepared for the July 1st deadline for receiving and providing 3T information. HCC is here to help you prepare for the DSCSA requirements. Healthcare Consulting is a full service Pharmacy Consulting firm that has been in business for over 25 years. HCC has been helping pharmacies plan, prepare and deal with critical business issues such as new DSCSA law since 1989. HCC is owned and operated by pharmacists who are experts in the development and implementation of policies and procedures in all areas of Pharmacy practice. It is also a good opportunity for you to ensure that your pharmacy is in compliance with all state licensing requirements and to have all of your pharmacies’ policies and procedures reviewed by experts! Contact us on line or call us today for a Free Consultation at 800-642-1652 to discuss how we can help you.

Bob Miller

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Compounding Pharmacy Consulting – NIH Pharmacy Shuts Down

NIH Pharmacy Shuts Down:

Compounding pharmacies are once again under scrutiny on a national level as The National Institutes of Health (NIH) suspended all operations of its Clinical Center Pharmaceutical Development Section (PDS) last Thursday. The pharmacy, located at the NIH clinical center in Bethesda, Md., was shut down after the discovery of a fungus contamination in two vials of albumin being used in cancer treatments. Six cancer patients had already been administered treatments from the same batch and so far none have developed any signs of infection or become ill. Additionally, the NIH will be notifying almost 250 other patients involved in 46 studies that may be potentially affected. Patients travel from almost everywhere in the United States to participate in experimental therapies taking place at the NIH. The NIH facility acts partly as a compounding pharmacy, making special orders of medications that aren’t routinely available elsewhere.

Of greater concern is the fact that a complaint about the NIH pharmacy had already led the Food and Drug Administration to inspect the facility in May. Inspectors documented numerous problems, including flaws in air handling systems, insufficient employee training and lack of compliance with standard operating procedures. Concerns about the safety of compounding pharmacies were raised after a 2012 outbreak of fungal meningitis tied to a compounding pharmacy in Massachusetts. In that case which drew a substantial amount of national media attention, 48 patients actually died and up to 14,000 people may have received the contaminated injections.

The biggest questions facing the NIH are all based around the issues of compliance regarding adherence to established policies and procedures. Various studies to date have shown that many compounding pharmacies have been slow to react to the newest guidelines of US797 regarding compliance. The most often cited reasons include:
– Leadership’s lack of knowledge &/or support
– Financial and budgetary restrictions
– Physical plant limitations
– Lack of available training & competency resources
– Time required to implement changes

A quote from Leigh Briscoe-Dwyer, the chief pharmacy and medication safety officer at North Shore-Long Island Jewish Health System really gets to the heart of the matter. “Because this is the NIH, the expectation is that standards are higher than you would expect from other sites,” Briscoe-Dwyer said. “It shows that no one is immune to failing to adhere to standard operating procedures. All of us involved in pharmacy need to pay attention. If it can happen at NIH, it can happen anywhere.”

If you are a compounding pharmacy, the time to get into compliance is now! Do not let small issues with regulatory compliance turn into serious threats to YOUR pharmacy. Be pro-active regarding the requirements to the USP 797 guidelines. Healthcare Consultants has been helping pharmacies since 1989. Let us help you ensure that your compounding pharmacy has no issues by contacting us today for a complete Compliance Review. Reach us online or call today at 800-642-1652.

Bob Miller

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