Massachusetts Controlled Substance Registrations
FAQ Reference Guide
To assist our customers with their Massachusetts Constrolled Substance Registrations (MCSR) compliance requirements, MedPro Systems (MedPro) is associating MA State License records to MCSR data for validation fulfillment, along with providing data quality checks, proactive monitoring, and ongoing data delivery and support. We recommend that organizations read, understand, and discuss their obligations with internal compliance and legal counsel and document their process and approach. For more information, please visit: https://www.mass.gov/orgs/massachusetts-controlled-substances-registration
Please refer to this guide for the most common and pertinent questions we have received related to MCSRs.
Enforcement and Expansion
Q: Is there a start date for the MA BOP to enforce compliance?
A: MedPro is not aware of any enforcement activities by Massachusetts related to MCSR. This is not a new regulation. What changed is the platform for license verification. See footnote.
Q: With regulations like Ohio TDDD and MCSR, it’s becoming increasingly complex to manage a 50-state operation and remain compliant. Are other states currently crafting this type of legislation or considering similar requirements?
A: MedPro monitors US states and territories for jurisdictional and profession-specific drug and device distribution requirements. In addition to Massachusetts, MedPro manages data required for Ohio TDDD and Florida HCCE compliance.
Requirements, Clarifications and Exceptions
Q: Would a Healthcare Provider attesting via signature that they have the required MCSR be acceptable? Could an attestation alleviate the need to get this MCSR data?
A: Massachusetts has not provided any guidance on using attestations vs MCSR license verification.
Q: Who is ultimately responsible for validating MSCR Schedule VI HCP license/location – the manufacturer, distributor, or both?
A: The manufacturer or distributor of record is responsible for ensuring compliance with state and federal regulations related to prescription drug distribution (trade and samples).
Q: Are there requirements for wholesalers?
A: Yes. See footnote.
Q: Is it still the responsibility of the HCP to register each address? Is there anything that can be done to impact this?
A: The practitioner is responsible for maintaining a MCSR for their primary address and each location where controlled substances are stored or dispensed. Massachusetts recommends manufacturers and distributors do not ship or provide sample prescription drugs to practitioners without a MCSR at the location of the distribution event. Outreach to your customers may help inform them of their obligation to have licenses at all locations for purposes of trade or sample distribution. Talk to MedPro about our IVCC call center.
Q: Does this apply to all drugs beyond controlled substances?
A: All prescription drugs are Massachusetts-controlled substances. See footnote.
MCSR applies to all trade and sample prescription drug distribution activities.
The MCSR is location-specific; it is required for the primary address and each location where controlled substances are stored or dispensed. Most practitioners will only need a MCSR for their primary practice location. Practitioners only need additional MCSRs if they take possession, store, and/or distribute prescription samples or trade drugs at a more than one location.
Q: Do MCSRs need to be validated when providing sample Rx items to an HCP?
A: See footnote.
MCSR applies to all trade and sample prescription drug distribution activities.
The MCSR is location-specific; it is required for the primary address and each location where controlled substances are stored or dispensed. Most practitioners will only need a MCSR for their primary practice location. Practitioners only need additional MCSRs if they take possession, store, and/or distribute prescription samples or trade drugs at a more than one location.
Q: Does the address on the MA MCSR license have to match exactly, down to the suite #?
A: Per MedPro’s conversation with the Massachusetts manufacturers and distributors, they should make a reasonable effort to ensure the address used for distribution is the same location as the verified MCSR address. We suggest you work with your internal compliance department to document your business rules and rationale statements regarding MCSR compliance.
Q: Do doctors need a MCSR license for each location?
A: The MCSR is location-specific; it is required for the primary address and each location where controlled substances are stored or dispensed. Most practitioners will only need a MCSR for their primary practice location. Practitioners only need additional MCSRs if they take possession, store, and/or distributes prescription samples or trade drugs at more than one location.
Q: Would the regulation be met if a Sales Representative asks the Physician if they have a valid MCSR at the address and the Physician checks a confirmation box at the time of sample request?
A: Massachusetts has not provided any guidance on using attestations vs MCSR license verification.
Q: How do I verify a location when no MCSR or the address is provided?
A: The state has noted that you should ask your customers to update their data.
How MedPro Can Help
Q: If MedPro were to assist with educating our customers, would there be a fee involved? How do we set something up?
A: Yes, these types of services are handled via our IVCC (Information Verification Call Center). For more information, contact us here or at inquiries@medprosystems.com.
Q: Will you send out a template for the MedPro platform so we can run our own reports to see who has a MCSR and who does not?
A: For any MedPro customers, please contact your Customer Success Account Manager, and we will provide the necessary information to perform an analysis.
Q: Is there a cost associated with your services to call our doctors to educate them on the MCSR rules?
A: Yes, we can provide a proposal based on the scope of your Massachusetts universe of providers and we can call using data provided from your CRM with or without additional enrichment from MedPro.
Q: How are you handling MCSR licenses that do not match?
A: MedPro has successfully associated active MCSR licenses with the associated MA provider’s practice license. Not all MA providers have an active MCSR.
Q: Has MedPro reached out to MA AMA and other HCP associations to support education?
A: MedPro has worked with the Massachusetts Program Counsel Department of Public Health – Drug Control Program to understand how the industry can comply with Massachusetts regulations to provide prescription drug products effectively in all cases. We have not engaged with third parties on their interpretation of MCSR requirements.
Footnote: Massachusetts General Laws, Chapter 94C, section 7 and the regulations of the Massachusetts Department of Public Health at 105 CMR 700.004 require every individual/facility who manufacturers, distributes, prescribes, administers, dispenses, or possesses controlled substances in Schedules II-VI (2-6) to be registered with the Department of Public Health (Massachusetts Controlled Substance Registration (MCSR)), and the US Drug Enforcement Administration (DEA) for Schedules II-V (2-5). Non-federal controlled substances are assigned to Massachusetts Schedule VI (6).
Individuals/facilities who only plan to manufacture, distribute, dispense, prescribe, administer, or possess Schedule VI (6) drugs only need to obtain a MCSR (and not a DEA number).
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