17.1 Nonsterile Compounding (USP <795>, RCSA 20-576-69)
Key Takeaways
- RCSA §§ 20-576-69 to 20-576-73 apply to a non-sterile compounding pharmacy licensed under CGS § 20-594 that dispenses non-sterile compounded products; a pharmacy that is part of a licensed hospital is excluded from that regulatory definition.
- The pharmacy must comply with current USP <795> and keep a policy-and-procedure manual covering compounding, dispensing, delivery, administration, storage, and use that itself complies with USP <795> (RCSA § 20-576-72).
- RCSA § 20-576-71(c) lets the pharmacy supply non-patient-specific nonsterile compounds to medicine, osteopathy, podiatry, dentistry, or veterinary practitioners for office administration, limited to a 30-day supply; federal FDCA § 503A still requires patient-specific compounding (or limited anticipatory compounding) unless a 503B/cGMP path applies.
- Current USP <795> default beyond-use dates, absent a USP–NF monograph or CNSP-specific stability data, are 14 days refrigerated for non-preserved aqueous preparations (water activity ≥ 0.6), 35 days for preserved aqueous, 90 days for nonaqueous oral liquids, and 180 days for other nonaqueous dosage forms — never later than the earliest component expiration.
- Adding a flavoring agent under CGS § 20-617a is exempt from USP <795>, USP <800>, and CGS § 20-633b(a)–(m). A non-sterile compounding pharmacy must be open at least 35 hours per week unless the Commission waives that under RCSA § 20-576-59.
Why nonsterile compounding is a Connecticut operations item
Quick Answer: A non-sterile compounding pharmacy is a CGS § 20-594 pharmacy that dispenses non-sterile compounded pharmaceutical products, not a pharmacy that is part of a licensed hospital (RCSA § 20-576-69). It must follow RCSA §§ 20-576-69 to 20-576-73 and current USP <795>. Keep a policy and procedure manual that itself complies with <795>. Default beyond-use dates (BUDs) come from water activity, not from a 180-day habit. FDCA § 503A still requires a patient-specific prescription (or limited anticipatory compounding) and bars essentially copies of commercially available drugs unless a shortage or a documented significant difference for that patient applies. Connecticut’s 30-day practitioner stock rule does not convert a 503A pharmacy into a manufacturer.
NABP Competency 4.5 tests compounding as a pharmacy-operations skill. The MPJE does not want a full USP recitation. It wants the pharmacist manager to know which Connecticut regulations attach, which USP chapter those regulations incorporate, what must be written down, how a BUD is assigned, and where federal 503A is stricter than a Connecticut office-use sentence.
RCSA § 20-576-70 states the purpose of §§ 20-576-69 to 20-576-73: positive patient outcomes through standards for pharmacist care; preparation, labeling, and distribution of non-sterile compounded products by § 20-594 pharmacies; and product quality and characteristics. That is the Commission’s reason for inspecting you against <795>, not a slogan to quote back.
Who is a non-sterile compounding pharmacy — RCSA § 20-576-69
As used in §§ 20-576-69 to 20-576-73:
- Commission means the Commission of Pharmacy.
- Non-sterile compounding pharmacy means a pharmacy licensed under CGS § 20-594 that dispenses non-sterile compounded pharmaceutical products, but does not include a pharmacy that is part of a licensed hospital.
- Non-sterile compounded pharmaceutical product means a drug dosage form, a dietary supplement, or a finished device made from the preparation of one or more substances.
Two exam traps sit in those definitions. First, hospital pharmacies are outside this RCSA cluster. They are not free of compounding standards — federal 503A/503B, USP, and (for sterile work) CGS § 20-633b still matter — but you do not answer a hospital-inpatient cream question by citing § 20-576-73 hours. Second, the product definition is broader than “a cream we mixed.” A compounded dietary supplement or finished device prepared from substances is inside the regulation when the pharmacy dispenses it as a nonsterile compound.
RCSA § 20-576-71(a) applies those sections to all non-sterile compounded pharmaceutical products, notwithstanding the location of the patient — home, hospital, nursing home, hospice, or doctor’s office. Shipping a pediatric suspension to a hospice does not take you out of §§ 20-576-69 to 20-576-73.
USP <795> is the compounding standard Connecticut wrote in
RCSA § 20-576-71(b) requires the pharmacy to comply with §§ 20-576-69 to 20-576-73 and the current USP Revised General Chapter 795, Pharmaceutical Compounding: Non-Sterile Preparations. Current is the word that retired the old simple/moderate/complex risk labels. Since the November 1, 2023 revision, USP <795> organizes CNSPs by water activity (Aw) and preservation, not by those three complexity names. Do not answer a 2026 MPJE item with “moderate compounding, 30-day BUD” as if the pre-2023 chapter still controlled.
RCSA § 20-576-72 is the paperwork the inspector asks for first: prepare and maintain a policy and procedure manual for the compounding, dispensing, delivery, administration, storage, and use of non-sterile compounded products. That manual shall be in compliance with USP <795>. A three-page “we follow USP” memo is not a manual.
At MPJE depth, the pharmacist manager must be able to show that the manual and the operation actually cover what current <795> expects of a designated person and the staff:
- One or more designated persons accountable for the facility’s compounding performance, operations, and personnel.
- Training and competency before compounding, then ongoing — garbing and hygiene as the chapter requires, plus process-specific skill (weighing, mixing, reconstitution, documentation).
- A master formulation record for each CNSP the pharmacy compounds (ingredients with amounts, calculations, equipment, mixing steps, quality checks, assigned BUD and storage, labeling).
- A compounding record for each preparation event (who compounded, date, lot/BUD, quantities, any deviations from the master).
- Component identity, beyond-use or expiration dating, and traceability if a recall or complaint arrives.
- A designated compounding area that is orderly, cleanable, and not the same counter used for lunch and spilled coffee.
DCP’s own USP 795 inspection form (September 2015 version still posted as a reference) is how Drug Control walks a Connecticut store. Questions on USP issues go to DCP.DrugUSPcompounding@ct.gov. The form is an inspection aid, not a second statute.
Beyond-use dates — assign them; do not invent them
A BUD is the date after which a compounded preparation must not be used. It is not the manufacturer’s expiration date on a stock bottle, though the BUD cannot exceed the earliest remaining expiration of any component. Current USP <795> default maximums, in the absence of a USP–NF compounded-preparation monograph or CNSP-specific stability information, are:
| CNSP type (current USP <795>) | Default maximum BUD | Storage |
|---|---|---|
| Non-preserved aqueous dosage form (water activity ≥ 0.6) | 14 days | Refrigerator |
| Preserved aqueous dosage form (water activity ≥ 0.6) | 35 days | Room temperature or refrigerator, as the chapter and formulation allow |
| Nonaqueous oral liquid (water activity < 0.6) | 90 days | As specified |
| Other nonaqueous dosage forms (water activity < 0.6) | 180 days | As specified |
Extending past those defaults requires formulation-specific stability data, not a gut feeling that “ointments last six months.” A water-containing pediatric amoxicillin suspension compounded without a preservative is a 14-day refrigerated problem, not a 180-day ointment problem. Putting “BUD 180 days” on every CNSP is how a pharmacy fails both USP and a Connecticut inspection.
Federal 503A sits on top of the Connecticut 30-day sentence
RCSA § 20-576-71(c) is the Connecticut office-use sentence candidates memorize and then misapply. A non-sterile compounding pharmacy may provide non-patient-specific non-sterile compounded products to practitioners of medicine, osteopathy, podiatry, dentistry, or veterinary medicine to administer to their patients in the course of their professional practice, either personally or under their direct and immediate supervision, except that the quantity shall be limited to a thirty day supply.
That is not a wholesale manufacturing license. FDCA § 503A (traditional pharmacy compounding) still conditions the new-drug-approval, adequate-directions, and cGMP exemptions on compounding by a licensed pharmacist (or physician) for an identified individual patient pursuant to a valid prescription, or in limited quantities in anticipation of a prescription based on a history of orders generated within an established relationship among pharmacist, prescriber, and patients. Anticipatory compounding is a limited buffer of what you historically fill — not a pallet of office stock.
Section 503A also provides that the compounder does not compound regularly or in inordinate amounts any drug products that are essentially copies of a commercially available drug. FDA’s copies guidance treats a product as essentially a copy when it has the same API, a strength within about 10 percent (or an easily substitutable multiple), and the same route — unless the prescriber determines that a change will produce a significant difference for that identified patient (for example, dye-free because of allergy) or the commercially available product is not commercially available because it is on FDA’s drug shortage list or is otherwise off the market. Compounding commercial lisinopril 10 mg tablets because they are cheaper is the classic fail.
On the MPJE, apply the more-restrictive overlay from Chapter 2. Connecticut’s 30-day practitioner allowance does not authorize 503A-style compounding of commercial copies, unlimited office stock, or interstate manufacturing. If the stem is office-use without a patient-specific prescription, look next to § 503B and CGS § 21a-70 in section 17.3 — not to “30 days, so it is fine.”
RCSA § 20-576-73 requires the non-sterile compounding pharmacy to be open at least 35 hours per week unless the Commission grants a waiver under RCSA § 20-576-59. That is the same 35-hour floor community pharmacies already know; compounding does not shrink it.
Flavoring is carved out — CGS § 20-617a
CGS § 20-617a defines a flavoring agent tightly (GMP quantity, GRAS or USP-standard ingredients, inert except for flavor, not greater than five percent of total weight). A pharmacist may add it on request of the prescriber, the patient, or the patient’s agent, or a pharmacist acting for a hospital. CGS § 20-633b(m) then exempts that flavoring from USP <795>, USP <800>, and § 20-633b(a)–(m). Turning a manufactured amoxicillin suspension into a strawberry-flavored manufactured suspension is not a full CNSP under those chapters. Turning bulk powder into a new suspension is compounding; adding flavor on top of that compound does not erase the <795> file for the compound itself.
Realistic Connecticut scenarios
A West Hartford independent compounds a dye-free omeprazole suspension for a named child because the commercial product contains a dye the prescriber documented as a problem. Master formulation record, compounding record, 14-day refrigerated BUD if it is a non-preserved aqueous CNSP, USP <795> manual on the shelf, pharmacy open 35 hours. That is 503A plus §§ 20-576-69 to 73.
The same store is asked to “just batch 200 bottles of commercial-strength omeprazole for Dr. Smith’s office freezer.” § 20-576-71(c) is not a 503A waiver. Without patient-specific prescriptions (or a true limited anticipatory history) and without a 503B / § 21a-70 path, that is the office-use trap.
A parent asks only that a manufactured antibiotic suspension be flavored. § 20-617a applies; do not rebuild a full <795> CNSP file solely because flavor was added.
Official anchors
- RCSA §§ 20-576-69 to 20-576-73 — definitions, USP <795>, 30-day practitioner quantity, policy manual, 35-hour week.
- CGS § 20-617a — flavoring agents; exemption from <795>/<800>/§ 20-633b.
- FDCA § 503A (21 U.S.C. § 353a) — patient-specific compounding, anticipatory limits, copies.
- DCP Sterile / Non-Sterile Compounding page (updated November 19, 2025) — USP 795 inspection form reference.
A Hartford pharmacy licensed under CGS § 20-594 compounds nonsterile creams for named patients. Which statement matches RCSA §§ 20-576-69 to 20-576-73?
In the absence of a USP–NF monograph or CNSP-specific stability data, which beyond-use date matches current USP <795> for a non-preserved aqueous oral suspension with water activity ≥ 0.6?
A New Haven pediatrician asks a 503A community pharmacy to flavor a manufactured amoxicillin suspension at the parent’s request and, separately, to send a 90-day office stock of a compounded dye-free omeprazole that copies a commercially available product. Which statement is correct?