Specialty pharmacy start-up and patient management program design is the work of writing the operating programs a new or expanding specialty pharmacy runs on: the patient management program, therapy-specific protocols, policies, workflows and training. It is for new or expanding specialty pharmacies. Integral Healthcare Solutions (IHS) drafts the programs, policies and clinical content for your pharmacist-in-charge and clinical pharmacists to review and approve, mapped to the accreditation standard you choose to build toward.
Last reviewed: October 2026.
What is specialty pharmacy start-up and patient management program design?
It is the build of a specialty pharmacy's programs before, or alongside, its first dispensing. The center of that build is the patient management program, because the accreditors define specialty pharmacy by it:
- URAC: "To be eligible to URAC's Specialty Pharmacy Accreditation, an organization must provide for the dispensing of specialty medication(s) to consumers and provide patient management services." URAC also states: "These days, specialty pharmacies are in the care management business - and those that can demonstrate that their processes deliver quality patient care are in great demand" (URAC Specialty Pharmacy).
- ACHC: "ACHC pharmacy standards are structured so that you can focus on requirements relevant to the specific focus of your pharmacy" (ACHC Pharmacy).
- NABP: "NABP's Specialty Pharmacy Accreditation is a 3-year accreditation for pharmacies providing an advanced level of pharmacy services and disease management for patients taking medications that require special handling, storage, and dispensing requirements." NABP adds: "With an overall emphasis on quality and safety, we review patient management, drug quality management, and regulatory compliance" (NABP Specialty Pharmacy Accreditation).
Versions: the URAC page links a standards file named "SPP v6.0 Standards at a Glance" and measures files named "2025_SP_Measures-at-a-Glance" and "2026_SP_Measures-at-a-Glance"; the version labels come from the file names, read October 2, 2026 (URAC). The ACHC page we reviewed does not show an edition of its specialty pharmacy standards. The full standards text of each accreditor is purchased; IHS builds to the copy you hold.
State pharmacy practice acts and board of pharmacy rules also govern the pharmacy where it is licensed and where it ships. This page does not summarize them; IHS identifies the provisions your counsel should read.
Who needs it and what triggers it
New or expanding specialty pharmacies need these programs written before they can show an accreditor how they work. Common triggers:
- Opening a specialty pharmacy, or adding specialty dispensing to an existing pharmacy, where the patient management services URAC's eligibility statement describes do not yet exist in writing (URAC).
- Adding therapy areas, where ACHC says its pharmacy standards are structured around the specific focus of your pharmacy (ACHC).
- Planning an accreditation application. NABP's eligibility includes "You are operational in all activities for at least 30 days" and "You are a licensed pharmacy operating in the United States, with current and active licenses in good standing, in all jurisdictions in which you are conducting business (unless licensure is not required by law)" (NABP). For NABP, the programs have to be operating, with records, for at least 30 days before you apply.
How IHS helps
IHS drafts the programs, policies and clinical content for your pharmacist-in-charge and clinical pharmacists to review and approve. The process:
- Gap assessment of what you have against the accreditation standard you choose and the licenses you hold.
- Questionnaires that collect your operating facts: therapy and payer mix, staffing, pharmacy system, shipping and cold-chain vendors.
- Document and evidence mapping: a crosswalk from each standard to the policy, form, log or record that meets it.
- Drafting a program description of your services and therapy areas; the patient management program (enrollment, assessment, care plan, clinical monitoring, adherence, patient education, opt-out, outcome tracking) with therapy-specific protocol templates; policies and procedures for intake, benefits investigation and financial assistance, dispensing and shipping, cold chain, complaints, adverse events, staff qualifications and training, and quality management; workflows; forms and patient-facing materials; and staff training material. Facts only you can supply are marked as open items.
- Mock review of the drafted programs against the standard you chose.
- Readiness support: a start-up work plan and training for the staff who will run the programs.
What you supply
Your licenses, therapy and payer mix, staffing, pharmacy system, shipping and cold-chain vendors, and access to your counsel for licensure questions.
Who decides what
Your pharmacist-in-charge and clinical pharmacists approve every clinical protocol and patient management document.
The limit
IHS does not obtain licenses, negotiate payer or manufacturer access, or make clinical decisions. Accreditors set their own eligibility rules; NABP, for one, requires 30 days in operation.
What to have ready
Gather what exists; missing items become part of the build.
- The specialty medications you will dispense and the patients you will serve (URAC eligibility: dispensing of specialty medications to consumers).
- A description of the patient management services you plan to provide (URAC eligibility).
- For each therapy area, the clinical monitoring and adherence support you plan to provide, as part of the patient management services URAC's eligibility statement describes (URAC eligibility).
- A list of every jurisdiction where you conduct business, with license status (NABP eligibility).
- Your target date to be "operational in all activities" and how you will keep records from that day (NABP eligibility).
- Your handling, storage and shipping arrangements, including cold-chain vendors (NABP: medications that "require special handling, storage, and dispensing requirements").
- How you will track drug quality and regulatory compliance (NABP review areas).
- The outcome measures you will report, checked against the Measures-at-a-Glance file URAC links, if URAC is your target (URAC).
- Which accreditor's standards you will build toward, and your purchased copy, for example the file URAC links, named "SPP v6.0 Standards at a Glance" (URAC).
Bring whatever you have to the introductory call; the gaps on this list are where the build starts.
How it compares
URAC, ACHC and NABP each offer specialty pharmacy accreditation, and building the programs is separate from all three. The table shows what each accreditor's own page says; it does not rank them.
| Option | What its page says | IHS page |
|---|---|---|
| URAC Specialty Pharmacy Accreditation | Eligibility requires dispensing specialty medications to consumers and providing patient management services; the page links a file named "SPP v6.0 Standards at a Glance" (URAC). | URAC Specialty Pharmacy |
| ACHC Specialty Pharmacy accreditation | ACHC says its pharmacy standards are structured around the specific focus of your pharmacy; edition not shown (ACHC). | ACHC Pharmacy |
| NABP Specialty Pharmacy Accreditation | A 3-year accreditation reviewing patient management, drug quality management and regulatory compliance; eligibility includes 30 days in operation (NABP). | NABP Specialty Pharmacy |
| Program design (this page) | Writing the pharmacy's programs; the accreditor's decision is separate. | See the Program Development practice line. |
What it costs
URAC, ACHC and NABP do not publish a fee schedule on the pages we reviewed; fees depend on scope. IHS scopes each engagement after a free introductory call.
What this is not
- This page is not legal advice, and IHS gives no opinion on state pharmacy law or licensure. Your counsel does.
- IHS does not obtain licenses, negotiate payer or manufacturer access, or make clinical decisions.
- IHS does not submit applications to URAC, ACHC, NABP or a board of pharmacy, and does not guarantee an accreditor's decision. IHS drafts; your pharmacy adopts the programs, runs them and files.
Frequently asked questions
What does a specialty pharmacy need in place before it dispenses its first specialty prescription?
Licensing is a question for your counsel. On the program side, the pharmacy needs written programs for how it will take in, dispense to and manage patients. IHS drafts the patient management program, policies, workflows and forms; your pharmacist-in-charge and clinical pharmacists approve the clinical content.
What is a patient management program, and what must it include?
URAC makes patient management services a condition of eligibility for its Specialty Pharmacy Accreditation, and NABP says it reviews patient management. The program IHS drafts covers enrollment, assessment, care plan, clinical monitoring, adherence, patient education, opt-out and outcome tracking. What a given accreditor requires is in its purchased standards.
Which policies and procedures does a new specialty pharmacy need?
IHS drafts policies and procedures for intake, benefits investigation and financial assistance, dispensing and shipping, cold chain, complaints, adverse events, staff qualifications and training, and quality management. Each is mapped to the standard you choose.
How do we design intake, benefits investigation, financial assistance and refill workflows?
IHS drafts each workflow from your questionnaire answers about your pharmacy system, payer mix and staffing. Your staff test them against real cases before launch, and your pharmacist-in-charge approves the clinical steps.
What clinical monitoring and adherence program should each therapy area have?
Your clinical pharmacists decide the clinical content. IHS drafts therapy-specific protocol templates for clinical monitoring and adherence inside the patient management program.
How long must we be operating before we can apply for specialty pharmacy accreditation?
Each accreditor sets its own eligibility. NABP's eligibility states that you are operational in all activities for at least 30 days. Check each accreditor's current eligibility page before planning dates.
Should we build to URAC, ACHC or NABP standards from the start?
That choice depends on your payers, manufacturers and plans for the pharmacy. IHS maps the build to whichever standard you choose once you hold a copy, and the drafted programs can be crosswalked to a second standard later.
How do we prepare for the outcome measures accreditors collect?
The URAC page links measures files named 2025_SP_Measures-at-a-Glance and 2026_SP_Measures-at-a-Glance. IHS builds outcome tracking into the patient management program so the data exists from your first patient; your staff collect and report it.
Which state licenses do we need for the states we ship to?
That is a question for your counsel and the boards of pharmacy involved. NABP's eligibility requires current and active licenses in good standing in all jurisdictions in which you conduct business (unless licensure is not required by law). IHS does not obtain licenses.
What is the difference between building the pharmacy's programs and getting accredited?
The build writes the programs your pharmacy runs. Accreditation is a review of how the pharmacy operates, and the accreditor decides the outcome. NABP, for one, requires 30 days in operation first. IHS covers each accreditor on its own page.