11.1 Compounding: Non-Sterile, Sterile & Hazardous Drugs

New York's Compounding Framework: Who Regulates What

Compounding in New York is governed primarily by 8 NYCRR Part 63 (the Commissioner's regulations implementing Education Law Article 137), administered by the New York State Education Department (NYSED) Office of the Professions and the State Board of Pharmacy — not, as in many states, by a health department. This is a structural fact worth memorizing: NY pharmacy licensure, establishment registration, and compounding oversight all run through NYSED and the Board of Regents, while the Department of Health (DOH) handles adjacent lanes such as controlled-substance automated dispensing at long-term care facilities (covered in 11.3) and hospital facility licensure under Article 28 of the Public Health Law.

Required Compounding Equipment — 8 NYCRR §63.6(b)(1)

Every registered pharmacy must possess specific compounding equipment. This list is explicit and testable:

Facility & Space Requirements — §63.6(b)(2)-(3)

A pharmacy's total space must be at least 300 square feet, of which the compounding and dispensing area must be at least 100 square feet. That area must have "heating and ventilation adequate to safeguard the purity and potency of drugs," adequate lighting, and hot and cold running water. A dedicated refrigerator maintained at 2°C to 8°C (36°F to 46°F) is required for temperature-sensitive drugs, and its use "shall be limited to the storage of drugs" — storing food, beverages, or specimens in the drug refrigerator is itself a citable violation.

Compounding CE and "Current Compounding Standards"

For registration periods beginning on or after January 1, 2023, every NY pharmacist must complete at least 3 hours of continuing education in compounding, and that CE must be "consistent with current compounding standards as determined by the department" (8 NYCRR §63.7(c)(3)(i)). Notice what this rule does not do: unlike some states — Pennsylvania, for example, names USP <795>, <797>, <800>, and <825> directly in its own compounding regulation — New York's Part 63 text does not itself enumerate specific USP chapter numbers. Instead, NY ties compliance to a moving target, "current compounding standards," which in professional practice means USP's General Chapters.

USP <795>/<797>/<800> in Practice

Nationally, USP <795> (nonsterile compounding) and USP <797> (sterile compounding) underwent major revisions that became official November 1, 2023, and USP <800> (handling of hazardous drugs) also became enforceable in November 2023. A widely cited NABP survey found that roughly 87% of state boards of pharmacy either fully require or otherwise incorporate USP <797> into their compounding rules. Because NY defers to "current compounding standards" rather than freezing chapter numbers into text, MPJE candidates should expect scenario questions that test the underlying USP concepts — sterile-compounding risk categories, hazardous-drug engineering controls, beyond-use dating logic — even though NY's own regulatory citation for those concepts is the CE rule, not a hard-coded equipment mandate.

Beyond-Use Dating Basics

A beyond-use date (BUD) is the date after which a compounded preparation should not be used or administered — distinct from a manufacturer's expiration date on a commercial product. A NY pharmacist assigning a BUD must never exceed the shortest expiration date of any component ingredient, the documented stability of the formulation, or the durability of the container, and should default to the more conservative of current USP guidance and any manufacturer data.

Hazardous Drug Handling in Practice

Although Part 63's equipment list does not name USP <800> directly, a NY pharmacist who compounds a hazardous drug (an agent identified on the NIOSH hazardous drug list — for example, many antineoplastics, some hormones, and certain antivirals) is still expected to meet "current compounding standards" for that category of work. In practice that means a containment primary engineering control (a biological safety cabinet or a compounding aseptic containment isolator) inside a negative-pressure room, dedicated personal protective equipment, medical surveillance for personnel who regularly compound hazardous drugs, spill kits, and segregation from non-hazardous compounding activity. The scope is broader than compounding alone: receiving, storage, dispensing, and administration of a hazardous drug all trigger the same handling expectations — even repackaging one.

Exam Scenario

A NY pharmacist is asked to compound a sterile ophthalmic suspension from nonsterile bulk active powder for a patient with no commercial alternative. Under national sterile-compounding standards this is high-risk-category work, demanding the most conservative BUD and the most rigorous environmental controls. The equipment list in §63.6(b)(1) — 6 mg scale, mortar and pestle — is baseline nonsterile equipment; it is necessary in every pharmacy but is not, by itself, sufficient for sterile or hazardous compounding. A pharmacist who compounds hazardous or sterile preparations using only the §63.6(b)(1) equipment list, without the additional engineering controls current standards require, has not met the "current compounding standards" bar the CE rule points to.

Traps

• The 6 mg-sensitivity scale and 0.1-500 mL measuring devices are baseline nonsterile compounding equipment required in every pharmacy — they are not sterile-compounding controls.
• "Consistent with current compounding standards as determined by the department" is a floating reference, not a citation to a specific USP edition — do not assume Part 63's text names USP <800> directly.
• The drug refrigerator's 2°C-8°C range and drug-only use restriction is a common inspection citation.
• NYSED/Office of the Professions regulates pharmacy compounding generally — DOH's role is limited to adjacent tracks (narcotics enforcement, hospital facility licensure), not general compounding oversight.