17.2 Sterile Compounding (USP <797>, RCSA 20-576-64)

Why sterile compounding has its own Connecticut license overlay

Quick Answer: Do not start sterile compounding in a Connecticut pharmacy until DCP and the Commission of Pharmacy approve a sterile pharmaceutical compounding addendum to the CGS § 20-594 license (or § 20-627 nonresident registration) after inspection (CGS § 20-633b(b)). Comply with USP chapters 797, 800, and 825 as they apply to sterile work. Name a designated pharmacist with commissioner-approved training. Report remodel plans 45 days ahead, emergency repairs within 24 hours, recertification within 5 days, environmental-sampling failures by the next business day, and patient-specific recalls within 24 hours. RCSA §§ 20-576-64 to 20-576-68 still require a USP <797> policy manual and a 35-hour week.

NABP Competency 4.5 tests sterile operations at pharmacist-manager depth: who may compound, which rooms and tests must exist, and which clock runs when something breaks. It is not a cleanroom-engineering exam.

The addendum — CGS § 20-633b(b)

§ 20-633b(a) defines sterile compounding pharmacy as a pharmacy or nonresident pharmacy that dispenses or compounds sterile pharmaceuticals, and defines sterile pharmaceutical as a dosage form devoid of viable microorganisms, including parenterals, injectables, surgical irrigants, and ophthalmics. USP chapters means chapters 797, 800, and 825 and their referenced companion documents, as amended.

Before sterile compounding:

• A new § 20-594 applicant that intends to compound sterile drugs files an addendum to the pharmacy application. DCP inspects. Compounding waits until written notice that DCP and the Commission approved the addendum.
• An existing § 20-594 pharmacy that intends to compound sterile drugs for the first time on or after July 1, 2014 files the same addendum and waits for the same written approval after inspection.
• A health care institutional pharmacy licensed under § 20-594 that intends to compound sterile drugs for the first time on or after July 1, 2023 files an addendum; DCP inspects; compounding waits for written approval. P.A. 23-19 added that institutional path.
• A new or existing nonresident pharmacy that will compound sterile drugs for sale or delivery in Connecticut files an addendum to the § 20-627 registration, supplies written proof of inspection by the home-state agency, and waits for DCP/Commission written approval.

Nothing in § 20-633b affects a licensed hospital’s ability to compound sterile pharmaceuticals for that hospital’s patients consistent with federal law. That hospital-patient sentence is not a community pharmacy loophole, and it is not a license to ship hospital CSPs across town as if they were 503A retail fills.

§ 20-633b(c) then says the sterile compounding pharmacy shall comply with the USP chapters and with all applicable federal and state statutes and regulations. RCSA § 20-576-64 still defines “sterile compounding pharmacy” more narrowly (a § 20-594 pharmacy that dispenses sterile products, excluding a pharmacy that is part of a licensed hospital). On the MPJE, the statute’s addendum and designated-pharmacist duties control for who needs the extra approval; the RCSA cluster still supplies the policy-manual and hours overlay for the community sterile pharmacy.

What the pharmacist manager must actually have — USP <797> at MPJE depth

Current USP <797> (official November 1, 2023) replaced low/medium/high risk with Category 1, 2, and 3 CSPs. Teach the rooms and tests, not every BUD row.

ISO Class 5 is the primary engineering control (PEC) — laminar-airflow workstation, biological safety cabinet, or isolator — where the sterile manipulation happens. The manager’s job is to keep that PEC certified, the rooms classified, and the people qualified. Immediate-use compounding is a separate, tightly limited <797> carve-out for CSPs that will be administered immediately; it is not a way to skip the addendum for a compounding program.

Personnel competency the exam expects you to have, not to perform on the test:

• Media-fill (aseptic process simulation) initially and on a repeating schedule (every 6 months for Category 1 and 2; every 3 months for Category 3).
• Gloved fingertip and thumb sampling after garbing (initial pass is 0 CFU on both hands) and after media-fill.
• Visual observation of hand hygiene, garbing, and aseptic technique.
• Environmental monitoring: nonviable particle counts to prove ISO class; viable air and surface sampling. Category 1 and 2 commonly use at least monthly surface sampling and every 6 months air sampling; Category 3 is more frequent (weekly surface is the usual chapter step-up). Action levels exist (for example ISO 5 air >1 CFU/m³). You do not need to memorize every cfu table; you need to know that exceeding them is a reportable Connecticut event under § 20-633b(f).

USP <800> is the hazardous overlay: containment PEC (C-PEC), negative-pressure rooms, and separate hazardous sterile workflow. § 20-633b(a)(5) already lists chapter 800 among the USP chapters a sterile compounding pharmacy must apply. Chapter 16 of this guide covers storage and NIOSH; this chapter’s exam point is that hazardous sterile compounding is not ordinary Category 2 in a positive-pressure buffer.

RCSA § 20-576-67 (and § 20-633b(h)) require a policy and procedure manual that complies with the USP chapters, covering compounding, dispensing, delivery, administration, storage, and use. RCSA § 20-576-68 requires a 35-hour week unless waived under § 20-576-59. RCSA § 20-576-66(a) applies the sterile RCSA cluster regardless of patient location.

Connecticut clocks the manager is graded on

§ 20-633b(e) — space and HVAC. If the pharmacy will remodel any sterile compounding area or adjacent space, relocate sterile space, or make a nonemergency upgrade or repair to HVAC or primary or secondary engineering controls, it must notify DCP in writing not later than 45 days before starting, with a plan subject to department review and approval. An emergency repair must be reported in writing not later than 24 hours after it starts. If USP requires sterile recertification afterward, only an independent licensed environmental monitoring entity may perform it, and the pharmacy files that recertification with DCP not later than 5 days after approval. In-house “we smoke-tested it ourselves” is not the statute.

§ 20-633b(f) — environmental sampling. Report in writing any known violation or noncompliance with viable and nonviable environmental sampling testing, as defined in the USP chapters, not later than the end of the next business day after discovery.

§ 20-633b(g) — recalls. Patient-specific prescription or medical-order CSPs: notify each patient or caregiver, the prescribing practitioner, and DCP not later than 24 hours after the recall is initiated. Non-patient-specific CSPs: notify each purchaser (to the extent contact information exists), DCP, and FDA not later than the end of the next business day.

§ 20-633b(i). Report any administrative or legal action commenced against the pharmacy by a state or federal regulator or accreditation entity not later than five business days after notice of commencement.

§ 20-633b(k). A practitioner, hospital, or health care facility that receives sterile pharmaceuticals shall report dispensing errors or suspected adulterated sterile products to DCP.

§ 20-633b(j) (as amended by P.A. 25-101, effective January 1, 2026) is the nonresident inspection cadence: submit an inspection report from a government agency with oversight or a third-party entity with expertise in sterile compounding showing USP <797> compliance. The initial report must be dated and show inspection during the six months immediately before the initial application. Then, not later than June 30 of each even-numbered year, a new report showing inspection not earlier than January 1 of that even-numbered year. A newly registered nonresident is not required to submit more than one inspection report during the calendar year after initial registration.

Designated pharmacist — § 20-633b(l) and DCP’s November 2025 page

A designated pharmacist is the pharmacist responsible for overseeing compounding of sterile pharmaceuticals and application of the USP chapters as they pertain to sterile compounding. Any § 20-594 pharmacy that provides sterile pharmaceuticals shall notify DCP of that pharmacist. The designated pharmacist must prove completion of a program approved by the commissioner demonstrating sterile-compounding competence. DCP’s November 19, 2025 sterile-compounding page lists the training areas (fundamentals; facility design and engineering controls; maintaining quality of the environment; non-hazardous and hazardous sterile compounding; personnel sampling; viable sampling; aseptic technique; documentation of master formulation and compounding records; equipment) and currently posted approved programs. Notify DCP when commencing or ceasing the designation (statute: immediately upon ceasing; DCP asks for email to DCP.PharmacistLicense@ct.gov). Nothing in the section prevents the designated pharmacist from also being the pharmacy manager.

Patient-specific versus the two-week RCSA leftover

§ 20-633b(d)(1) allows patient-specific sterile pharmaceuticals to patients, to practitioners of medicine, osteopathy, podiatry, dentistry, or veterinary medicine, or to a DPH-licensed acute or long-term care hospital or health care facility.

§ 20-633b(d)(2) is the office-stock gate: if the pharmacy provides sterile pharmaceuticals without a patient-specific prescription or medical order, it shall also obtain a CGS § 21a-70 certificate of registration (manufacturer/wholesaler) and any required federal license or registration. It may keep on-site inventory no greater than a 30-day supply, calculated from completion of compounding including time for third-party analytical testing under the USP chapters.

RCSA § 20-576-66(c) still says a sterile compounding pharmacy may supply compounded products to those same practitioner types for office administration, limited to a two-week supply. Teach both. The statute is the later, tighter operational gate: non-patient-specific sterile work needs § 21a-70 plus federal 503B, not a two-week RCSA sentence standing alone. Section 17.3 is where 503A/503B mixing is tested.

Realistic Connecticut scenarios

A Stamford community pharmacy wants to start TPN. It files the § 20-633b addendum, waits for DCP inspection and written approval, names a designated pharmacist who finished a commissioner-approved sterile program, and builds ISO 5 PECs in an ISO 7/8 suite before assigning Category 2 BUDs. Compounding on the first Saturday “while the application is in the mail” is unlicensed sterile compounding.

The PEC’s HVAC fails on a Sunday. The manager starts the emergency repair and notifies DCP in writing within 24 hours. After the repair, an independent environmental-monitoring firm recertifies; the report is at DCP within 5 days if USP required recertification. Viable air sampling then exceeds the ISO 5 action level on Tuesday; DCP is notified by the end of Wednesday (next business day).

A patient-specific CSP is recalled Wednesday noon. Each patient or caregiver, the prescriber, and DCP are notified by Thursday noon.

Official anchors

• CGS § 20-633b (2025) — addendum, USP chapters 797/800/825, designated pharmacist, 45/24/5-day clocks, recalls, nonresident inspections (P.A. 25-101).
• RCSA §§ 20-576-64 to 20-576-68 — community sterile pharmacy definition, USP <797> manual, 35 hours, two-week practitioner quantity.
• DCP Sterile Compounding (November 19, 2025) — designated-pharmacist training areas and approved courses.