9.1 Pharmacy Licensure, Facilities & Required References

Pharmacy Licensure, Facilities & Required References

Pharmacy facilities are licensed under 247 CMR 6.00, and the operating standards sit in 247 CMR 9.00. Compounding adds two further chapters — draft 247 CMR 17.00 for sterile and draft 247 CMR 18.00 for non-sterile.

[!WARNING] 247 CMR 17.00 and 18.00 are Board drafts, not promulgated regulations. Both documents are headed DRAFT (proposed new section), and the promulgated compilation of the Board's rules stops at 247 CMR 21.00; the Board's own pharmacy application checklist still tells applicants to review the draft non-sterile compounding regulations. What binds today is M.G.L. c. 112, §§ 39F through 39J, the compounding licence categories in 247 CMR 6.00, the duty in 247 CMR 9.01(3) to adhere to the most current USP chapters, and published Board policy. Learn the draft numbers because they are how the Board describes its expectations and how question writers refer to them — but if an item asks what a promulgated regulation requires, the answer runs through c. 112, 247 CMR 6.00 and USP.

One promulgated facility number is worth memorising exactly: under 247 CMR 9.19(2), a pharmacy that obtained its Drug Store pharmacy licence on or after 1 July 2020 must have a prescription area of at least 325 square feet. The date qualifier is part of the rule — an older pharmacy is not brought within it by continuing to operate.

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Licence Categories

Massachusetts licenses the facility, by category, and a pharmacy that adds an activity generally needs an added licence rather than a variation of an existing one.

[!IMPORTANT] Nuclear pharmacy is 247 CMR 13.00, not 11.00. 247 CMR 11.00 is registration under M.G.L. c. 94C. Getting these two the wrong way round is a common citation error.

Inspection before licensure

An applicant for a specialty compounding licence must achieve a satisfactory Board inspection of the proposed pharmacy before an original licence is issued. A complex non-sterile compounding application must include certified blueprints of the dedicated compounding room showing the placement of containment hoods, a detailed HVAC design plan with a written description, and an attestation of intent to compound signed by the Manager of Record, the pharmacist in charge of complex non-sterile compounding where applicable, and the applicant.

Renewal

Specialty compounding licences expire on December 31 of each year following issuance, and a renewal application must include copies of all reports and correspondence relating to inspections by any state or federal agency during the licensing period. Verify the current expiration cycle for the particular licence category with the Board rather than assuming it matches the pharmacist personal-registration cycle, which is a separate two-year cycle ending on December 31 of even-numbered years.

Change of ownership

A change of ownership requires an application for transfer of ownership, including the full name of the new owner, an official bill of sale, and — for a corporate purchaser — the articles of organisation or foreign corporation registration. Where the change of ownership also changes the Manager of Record, the change-of-MOR requirements in 247 CMR 6.10 apply in addition.

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Compounding Space Requirements

Massachusetts sets explicit floor areas for compounding, which is unusual and therefore testable.

[!CAUTION] The clean-room rule reaches further than it looks. Because sterile compounding may not be conducted without a Board-approved clean room, activities such as preparing pre-filled syringes from a sterile source fall inside the requirement. "It is only a syringe" is not an answer.

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Equipment, Sanitation and Signage

• Cleanliness. The pharmacy must be kept clean and sanitary (247 CMR 6.01(5)).
• Balances. Balances and scales must be sealed each calendar year, and new balances must be designated "legal for trade."
• Refrigeration. Refrigerators and freezers used to store medication are subject to the Board's monitoring expectations; storage must be within the labelled conditions for each product.
• Signage. Required signage includes the patient consultation area, the patient's right to counselling, hours of operation, the Manager of Record's name, and lock boxes (247 CMR 6.01(5)(d)(1)).
• Licence display. All employees performing pharmacy technician duties must hold a licence, and employee and pharmacy licences must be valid, current and properly displayed (247 CMR 6.02(3)).

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The Required Reference Library — 247 CMR 9.19

Every pharmacy must hold, in hard copy or by electronic access, a defined set of references. The Massachusetts list is specific and is not the generic "USP-NF plus a drug interaction reference" list that appears in many study aids:

1. A current copy or electronic version of the Massachusetts List of Interchangeable Drugs, including the Orange Book, the Additional List and the Exception List.
2. A current copy or electronic access, with quarterly updates, to a compendium appropriate to the practice setting, approved by the pharmacist Manager of Record.
3. A current copy or electronic version of the laws and regulations governing the practice of pharmacy, including:
   • M.G.L. c. 94C;
   • M.G.L. c. 112, §§ 24 through 42A;
   • 105 CMR 700.000 — implementation of c. 94C;
   • 105 CMR 720.000 — List of Interchangeable Drug Products;
   • 105 CMR 721.000 — Standards for Prescription Format and Security; and
   • 247 CMR.
4. A current copy or electronic version of Plumb's Veterinary Drug Handbook or an equivalent veterinary reference.

[!WARNING] The veterinary reference is mandatory and is regularly missed. A community pharmacy that dispenses even occasional veterinary prescriptions must hold a veterinary drug reference. So is the requirement that the MOR approve the practice-setting compendium — it is not enough that some reference exists.

Certain 247 CMR 9.19 requirements are disapplied to non-resident pharmacies and to institutional sterile compounding pharmacies; the regulation lists the specific paragraphs that do not apply.

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Worked Traps

• A pharmacy plans to begin preparing pre-filled syringes without a clean room. Prohibited — 247 CMR 6.01(5)(c).
• A pharmacy compounds transdermal gels from bulk API in a 60-square-foot side room. Insufficient — the Board's complex non-sterile standard is dedicated compounding rooms totalling at least 100 square feet, plus the specialty licence under M.G.L. c. 112, § 39H and 247 CMR 6.07.
• A pharmacy holds the Orange Book but not the Massachusetts Additional and Exception Lists. Non-compliant with 247 CMR 9.19(1)(a).
• A prescription balance was last sealed 18 months ago. Non-compliant — balances must be sealed each calendar year.