Issuance of MCSR to health facilities
Regulations of the Department of Public Health at 105 CMR 700.003 permit the issuance of a Massachusetts Controlled Substances Registration (MSCR) to licensed health facilities as defined in 105 CMR 700.001. A health facility includes the following:
- A hospital, hospital pharmacy, long-term care facility or clinic licensed or maintained by the Department
- A public medical institution as defined in M.G.L. c. 118E § 8
- Any institution licensed or maintained by the Department of Mental Health
- Any hospital, long-term care facility or clinic maintained by the Commonwealth
- Any ambulance service licensed by the Department to provide Advanced Life Support services
Health facilities with an MCSR are advised that such registrations are not transferable. A new MCSR is required for a change in name, ownership or address. An MCSR is valid for one year and must be kept current.
For further information, please contact the Drug Control Program.
Requirements for individuals with limited medical licenses
Regulations of the Department of Public Health at 105 CMR 700.004 (B)(5) permit residents and clinical fellows who have limited medical licenses and wish to prescribe, dispense and administer controlled substances to utilize the registration of the hospital in which he/she is employed provided the following criteria are met:
- A person must be authorized to dispense controlled substances under M.G.L. c. 112, if applicable
- Such dispensing must be done in the usual course of business or professional practice
- The hospital by whom a person is employed must verify with the Board of Registration in Medicine that the individual is permitted to dispense controlled substances
- The person must only act within the scope of his/her employment at the hospital
- The hospital must authorize the person to dispense controlled substances under the registration number of the hospital and designate a specific suffix number to the hospital's registration number preceded by a hyphen for each person authorized
- The hospital must maintain a current list of internal codes and make these codes available at all times to other registrants, the Commissioner and authorized law enforcement agencies
It should be noted that individual hospitals determine whether or not they wish to permit persons with limited licenses to use the registration of the hospital. Should a hospital determine that they do not want individuals with limited licenses to utilize the hospital's registration, the physician must apply to the Department and, where applicable, the U.S. Drug Enforcement Administration (DEA), and receive Controlled Substances Registrations for the period of time for which their limited license is issued. Upon full licensure by the Board of Registration in Medicine, a physician must then reapply to the Department, and, where applicable, to the DEA for a new full registration(s). The appropriate fee must accompany the application to the Department. The newly issued registration will not be restricted to the period of time in which the limited license was valid.
Address for Individual Practitioner Massachusetts Controlled Substance Registration (MCSR) Appli
This Circular Letter is issued by the Drug Control Program (DCP), which is part of the Bureau of Health Professions Licensure (BHPL), regarding the address to be provided in Massachusetts Controlled Substance Registration (MCSR) applications and renewals for practitioners listed in 105 CMR 700.004(A)(2).
A practitioner must have an MCSR for each location where they are responsible for the purchase and/or storage of controlled substances. The address provided for the application must be that of the location. For example, if a practitioner MCSR is used to purchase controlled substances and authorize storage at two separate practice offices, that practitioner must have two separate MCSRs, one for each such practice office. Each of the MCSR applications must list the physical address of the practice office to be covered by the MCSR.
If a practitioner is not responsible for the purchase and/or storage of controlled substances, they may use any address where DCP can direct program communications for the practitioner. For example, if a Practitioner only prescribes and administers controlled substances, they may use any address where the practitioner can be regularly reached, including the following:
- A post office box or other mail collection type location is permissible for this category of MCSR. The practitioner will be responsible for the prompt receipt and response to communications sent to such an address.
- A practitioner may also elect to use a home address, noting that all MCSR related addresses are considered public information, and will be provided in response to public records requests, unless the practitioner qualifies for a Public Records Law exemption and requests suppression of this personal information.
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Please direct any questions or concerns to The Drug Control Program at email@example.com.
Massachusetts Controlled Substance Registrations (MCSRs) for Third Party Logistics Providers, Vi
This Circular Letter is issued by the Drug Control Program (DCP), which is part of the Bureau of Health Professions Licensure, regarding registration of Third Party Logistics Providers (3PLs), Virtual Manufacturers and Virtual Distributors. The purpose is to assist registrants who conduct these kinds of operations to understand which of the three MCSRs available for virtual activities best meets the needs of their business.
- Selecting the Appropriate MCSR Category
A Virtual Manufacturer is a person/entity with a principal place of business in the Commonwealth of Massachusetts but which never takes physical possession of controlled substances in the Commonwealth. An example of a Virtual Manufacturer could be a person/entity with a principal office in Massachusetts, while its manufacturing operations are located in another state. Manufacturing operations are managed or directed in Massachusetts, but no controlled substances are manufactured or stored in Massachusetts. An MCSR for virtual manufacturing would also authorize the person/entity to conduct virtual distribution of its own controlled substance products.
A Virtual Distributor is a person/entity with a principal place of business in Massachusetts but which never take physical possession of controlled substances in Massachusetts. An example of a Virtual Distributor could be a person/entity with a principal office in Massachusetts, while its distribution centers, warehouses, trucking operations, etc. are all located in other states. Distribution operations are managed or directed in the Massachusetts, but no controlled substances are received or stored in Massachusetts.
A 3PL is an entity that provides or coordinates warehousing, or other logistics services, of a product in interstate commerce on behalf of a manufacturer, wholesale distributor, or dispenser of a product, but does not take ownership of the product, nor has responsibility to direct the sale or disposition of the product. 3PLs are federally regulated under 21 U.S.C. § 360eee‑3. A 3PL may choose to conduct purely virtual activities in Massachusetts , where it directs or manages from Massachusetts but does not receive or store controlled substance here. However, under current federal law, a 3PL may also employ a business model where it takes custody of controlled substances as part of the logistical arrangements being made. An example of this might be that a 3PL chooses to store controlled substances in its warehouse or distribution center located in Massachusetts as part of its operations.
The primary difference between Virtual Manufacturers/Distributors and 3PLs is that Virtual Manufacturers and Distributors never take possession of any controlled substance in Massachusetts, while a 3PL may choose to do so.
- Pre-Registration Inspections
Virtual Manufacturers and Distributors register with the Commonwealth of Massachusetts primarily because regulators in other states require that they be registered in their “home” state to conduct operations in the other state. For these registrants, no physical inspection of their premises in Massachusetts will be conducted, unless requested. If, at any point, a Virtual Manufacturer or Distributor plans to have controlled substances on site, it must register with DCP for an appropriate MCSR (e.g. manufacturer or distributor) and complete an inspection.
Federal law requires that a 3PL be registered with any state where the 3PL distributes a controlled substance to or from such state. Federal law also bars states from licensing/registering 3PLs as wholesale distributors. Therefore, the Drug Control Program is making a 3PL MCSR available for this kind of business. To register, a 3PL will need to certify on its initial application and any subsequent renewal applications whether it will be taking custody of controlled substances in Massachusetts. If it is taking custody in Massachusetts, an inspection will be conducted of the necessary premises. If it is registering here for purely virtual activities, no inspection will be conducted, unless requested.
Please direct any questions or concerns to the Drug Control Program: firstname.lastname@example.org.
 M.G.L. c. 94C, §7(i); 105 CMR 700.001 (Definitions).
 M.G.L. c. 94C, §7(i); 105 CMR 700.001 (Definitions).
 21 U.S.C. § 360eee‑3(a).
 21 U.S. Code § 360eee–4(b)(2).