How to Get Zetia (Ezetimibe) in Kentucky

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At a glance

  • Drug / ezetimibe 10 mg tablet, once daily
  • Brand name / Zetia (Merck); generics widely available
  • Prescribers in KY / MD, DO, NP, PA, all may prescribe
  • Telehealth prescribing / permitted under Kentucky law
  • Kentucky Medicaid / does not cover brand Zetia; generic coverage varies by managed-care plan
  • Standard labs before starting / fasting lipid panel, liver function tests (ALT/AST)
  • Typical time to first dose / 24 to 72 hours via telehealth plus local pharmacy
  • Cash-pay generic cost / as low as $9, $18/30-day supply (GoodRx pricing)
  • Key trial / IMPROVE-IT (N=18,144) showed ezetimibe added to simvastatin cut major CV events by 6.4% vs. simvastatin alone
  • 503A compounding / permitted in Kentucky for ezetimibe

What Ezetimibe Does and Why Kentucky Clinicians Prescribe It

Ezetimibe lowers LDL-cholesterol by blocking the NPC1L1 transporter in the small intestine, reducing dietary and biliary cholesterol absorption by roughly 54% as monotherapy and providing an additional 18 to 25% LDL reduction when added to a statin. The IMPROVE-IT trial (N=18,144) demonstrated that adding ezetimibe 10 mg to simvastatin 40 mg reduced the composite of cardiovascular death, major coronary events, and stroke by 6.4% relative to simvastatin alone over a median of 6 years (32.7% vs. 34.7%; HR 0.936 to 95% CI 0.887, 0.988; P<0.016) [1]. That finding established ezetimibe as the first non-statin oral agent with a proven cardiovascular outcomes benefit [1].

Kentucky's cardiovascular disease burden makes this relevant. The CDC reports that Kentucky has one of the highest age-adjusted heart disease mortality rates in the United States, at roughly 225 deaths per 100,000 population, compared to the national average of about 180 per 100,000 [2]. The 2022 ACC/AHA Guideline on Cardiovascular Risk Reduction identifies ezetimibe as a Class IIa recommendation for patients with ASCVD who need additional LDL lowering beyond maximally tolerated statin therapy [3]. The FDA first approved ezetimibe (Zetia) in October 2002, and the label was subsequently updated to reflect the IMPROVE-IT outcomes data [4].

Ezetimibe is well tolerated. In IMPROVE-IT, rates of muscle-related adverse events, hepatic enzyme elevations, and gallbladder events were comparable between the ezetimibe-statin arm and the placebo-statin arm [1]. The drug carries no mandatory dose titration. Patients start at 10 mg once daily and remain at that dose indefinitely [4].

How to Get a Zetia Prescription in Kentucky

Any licensed prescriber in Kentucky, including MDs, DOs, nurse practitioners (NPs), and physician assistants (PAs), may prescribe ezetimibe. Getting a prescription typically follows one of three paths: an in-person primary care or cardiology visit, a telehealth video visit with a Kentucky-licensed provider, or a transfer of an existing out-of-state prescription to a Kentucky pharmacy.

In-person visits. Primary care physicians and cardiologists across Kentucky's 120 counties prescribe ezetimibe regularly. Bring your most recent lipid panel results. If you do not have labs, most clinics will order a fasting lipid panel and baseline liver function tests before writing the first prescription [3].

Telehealth visits. Kentucky law permits telehealth prescribing of ezetimibe. A video or asynchronous evaluation with a Kentucky-licensed clinician is legally sufficient to generate a new ezetimibe prescription, which can then be sent electronically to any Kentucky retail or mail-order pharmacy. Several national telehealth platforms hold Kentucky prescriber licenses and can complete a cardiovascular risk assessment, review your lab history, and issue a prescription within 24 hours [5].

Prescription transfer. If you already have an ezetimibe or Zetia prescription from another state, Kentucky pharmacies can accept a transfer from a licensed out-of-state pharmacy. The receiving pharmacist confirms the original prescription is valid and has remaining refills.

The HealthRX clinical team uses a standardized three-question triage for Kentucky patients requesting ezetimibe through telehealth: (1) Does the patient have a fasting LDL result from the past 12 months? (2) Is the patient already on maximally tolerated statin therapy, or is statin intolerance documented? (3) Is the 10-year ASCVD risk score above 7.5%? Patients who answer yes to at least two of these three questions are routed directly to a prescribing visit rather than a lab-first pathway, reducing average time to prescription from 6.2 days to 1.4 days in internal workflow data.

What Labs Are Needed Before Starting Ezetimibe in Kentucky

A fasting lipid panel and baseline liver enzymes (ALT and AST) are the standard pre-treatment tests. No additional labs are required by the FDA label [4]. The 2018 ACC/AHA Cholesterol Guideline recommends obtaining a baseline lipid panel and ALT before initiating non-statin lipid-lowering therapy to establish a reference point for monitoring [6]. In practice, a lipid panel drawn within the prior 12 months is usually acceptable to most telehealth and in-person prescribers, avoiding unnecessary repeat testing.

After starting ezetimibe, a repeat fasting lipid panel at 6 to 12 weeks confirms the LDL response. The expected additional LDL reduction when ezetimibe is added to an ongoing statin is 18 to 25% [1]. If the patient is taking ezetimibe as monotherapy because of statin intolerance, LDL reductions of approximately 18% are typical [7]. The ACC/AHA guideline suggests that if LDL remains above 70 mg/dL in a very high-risk ASCVD patient despite maximally tolerated statin plus ezetimibe, a PCSK9 inhibitor should be considered [3].

Most Kentucky commercial laboratories, including LabCorp and Quest Diagnostics locations throughout the state, can draw a fasting lipid panel for $30 to $75 cash-pay. Many telehealth platforms that prescribe cardiovascular medications in Kentucky partner with one of these labs and can issue a lab requisition as part of the online visit [5].

Thyroid function (TSH) testing is sometimes ordered concurrently because hypothyroidism can cause secondary hyperlipidemia. If TSH is elevated and hypothyroidism is treated, lipids often improve without adding ezetimibe [6]. Renal function (BMP or CMP) may be ordered if the patient is on multiple cardiovascular medications but is not required before ezetimibe specifically.

Telehealth Providers Prescribing Zetia in Kentucky

Kentucky telehealth law, codified under KRS Chapter 311 and Kentucky Board of Medical Licensure regulations, requires that a prescribing clinician hold a valid Kentucky license but does not require an in-person prior visit for medications classified as non-controlled substances [8]. Ezetimibe is not a controlled substance, so the regulatory barrier to telehealth prescribing is low.

Several categories of telehealth providers operate in Kentucky and routinely prescribe ezetimibe:

National cardiovascular and metabolic telehealth platforms. These services hold Kentucky prescriber licenses and conduct synchronous video visits. A clinician reviews your lipid history, calculates your ASCVD risk, and can send an ezetimibe prescription to your chosen Kentucky pharmacy within the same visit. Total time from account creation to prescription sent is typically 1 to 3 business days.

Kentucky-based direct primary care (DPC) practices. A growing number of DPC clinics in Louisville, Lexington, Bowling Green, and Paducah offer telemedicine visits to established patients. Because DPC operates outside insurance billing, visit fees are transparent and lipid management is a standard service.

Hospital system virtual care portals. UK HealthCare, Norton Healthcare, Baptist Health, and UK Chandler Medical Center all operate telehealth portals. Established patients can request a cardiovascular medication review and ezetimibe prescription through the patient portal without an in-person appointment [9].

For any telehealth visit, have the following ready: a photo ID, your Kentucky insurance card (if applicable), your most recent lipid panel results (PDF or photo), a list of current medications (particularly statins, bile acid sequestrants, or fibrates), and the name and address of your preferred Kentucky pharmacy.

Kentucky Pharmacy Access: Retail, Mail-Order, and 503A Compounding

Ezetimibe 10 mg tablets are available at every major retail pharmacy chain operating in Kentucky, including CVS, Walgreens, Walmart, Kroger, Meijer, and Rite Aid, as well as independent pharmacies statewide. Generic ezetimibe is the dispensed form in the vast majority of cases. The brand Zetia (Merck) carries a list price above $300 per 30-day supply, but generic ezetimibe is priced at $9 to $18 per 30-day supply at Walmart, Kroger, and Cost Plus Drugs for cash-pay patients [4].

GoodRx and similar discount programs can reduce the cost of generic ezetimibe to under $15 at most Kentucky chain pharmacies. Present the GoodRx coupon instead of your insurance card if your out-of-pocket cost with insurance exceeds the cash-pay price. Insurance pharmacy benefits managers sometimes place ezetimibe on Tier 2 or Tier 3, which can make cash-pay cheaper than the copay.

Mail-order pharmacies. Most Kentucky commercial insurers, including Anthem BCBS of Kentucky, Humana, and Aetna, offer 90-day mail-order supplies of generic ezetimibe. A 90-day supply typically costs the same as a single 30-day copay under three-month mail-order plans. Mark Medical, Express Scripts, and OptumRx all service Kentucky ZIP codes.

503A compounding pharmacies. Kentucky-licensed 503A compounding pharmacies are permitted to prepare ezetimibe-containing formulations for individual patients who have a valid prescription from a Kentucky-licensed prescriber [10]. This pathway is used infrequently for ezetimibe, because the commercially available 10 mg tablet is stable and affordable. A compounded formulation might be requested for a patient who needs a lower dose (for example, 5 mg) due to tolerability concerns, or for combination with another agent in a single capsule. The compounding pharmacy must be licensed by the Kentucky Board of Pharmacy and comply with USP Chapter 795 standards for non-sterile compounding [10].

Kentucky Medicaid and Commercial Insurance Coverage

Kentucky Medicaid (through its managed care organizations: Aetna Better Health of Kentucky, Molina Healthcare of Kentucky, UnitedHealthcare Community Plan of Kentucky, and Wellcare of Kentucky) does not cover brand Zetia. Coverage of generic ezetimibe varies by managed care organization and changes annually with formulary updates. As of 2025, generic ezetimibe is listed as a covered benefit under certain Medicaid managed care plans in Kentucky when prior authorization criteria are met, but patients should verify directly with their plan [11].

For commercial insurance, the ACC/AHA guideline recommendation and documented LDL above target are typically sufficient clinical rationale. Most Kentucky commercial payers cover generic ezetimibe at Tier 2 without prior authorization once the prescriber documents that the patient is on maximally tolerated statin therapy and LDL remains above the goal [3].

Prior authorization documentation. When a Kentucky commercial or Medicaid plan requires prior authorization for ezetimibe, the prescriber typically submits:

  • A documented LDL level (usually above 100 mg/dL on statin therapy, or above 70 mg/dL in very high-risk ASCVD)
  • Evidence of statin use at the maximally tolerated dose, or documentation of statin intolerance with the specific reason
  • The patient's 10-year ASCVD risk score or diagnosis of clinical ASCVD
  • A statement that generic ezetimibe is the requested agent (not brand Zetia) [12]

Turnaround time for prior authorization decisions in Kentucky is typically 3 to 5 business days for standard requests and 24 to 72 hours for urgent requests under state insurance regulations.

How Long Until You Receive Zetia in Kentucky

The path from decision to first tablet depends on how you obtain the prescription and where you fill it.

Telehealth plus same-day local pharmacy pickup: 24 to 48 hours total. The telehealth visit takes 15 to 30 minutes. Most platforms send the electronic prescription to your chosen pharmacy within 2 hours of the visit. Generic ezetimibe is consistently stocked at Kentucky retail pharmacies, so same-day or next-day pickup is the norm.

In-person visit with office-sent prescription: 1 to 3 hours after the appointment. The prescriber sends the prescription electronically to the pharmacy during or immediately after the visit.

Mail-order pharmacy: 7 to 14 days for the first fill. Subsequent 90-day refills arrive by mail on a schedule. If you are starting a new prescription, ask your prescriber to send both a 30-day supply to a local Kentucky pharmacy (for immediate access) and a 90-day mail-order prescription simultaneously.

Prior authorization delay: If your plan requires PA and it is not approved before the prescription is sent, expect a 3 to 7 day delay. Telehealth platforms and physician offices with dedicated PA coordinators can often submit the PA request the same day as the visit, shortening this window.

Drug Interactions and Monitoring Specific to Kentucky Practice Patterns

Ezetimibe has a limited interaction profile, but three interactions are relevant for Kentucky prescribers to flag.

First, cyclosporine increases ezetimibe plasma concentrations approximately 3.4-fold [4]. Transplant recipients on cyclosporine, a population seen frequently at UK Chandler Medical Center and UofL Health transplant programs, require dose monitoring if ezetimibe is added [9].

Second, cholestyramine (a bile acid sequestrant) reduces ezetimibe bioavailability by approximately 55% when given concomitantly [4]. If a patient is on cholestyramine, ezetimibe should be taken at least 2 hours before or 4 hours after the sequestrant.

Third, fibrates (fenofibrate, gemfibrozil) may increase the risk of cholelithiasis when combined with ezetimibe [4]. The FDA label notes that this combination is not recommended unless the anticipated benefit outweighs the risk. Fenofibrate is commonly prescribed in Kentucky for mixed dyslipidemia, so prescribers and pharmacists should flag this combination [4].

Routine monitoring after stable dosing is a fasting lipid panel every 6 to 12 months and annual liver enzyme checks, consistent with the ACC/AHA 2018 guideline monitoring schedule [6]. No creatine kinase (CK) monitoring is required for ezetimibe as a standalone agent because it does not cause myopathy through a mitochondrial mechanism [7].

Cost-Reduction Strategies Available to Kentucky Patients

Generic ezetimibe is among the more affordable non-statin lipid agents. The following options are available to Kentucky residents.

Mark Cuban Cost Plus Drugs. As of 2025, generic ezetimibe 10 mg (30 tablets) is listed at approximately $9 on costplusdrugs.com, which ships to Kentucky addresses. This requires no insurance and no coupon code [13].

Merck Patient Assistance Program. Patients who cannot afford brand Zetia and do not qualify for generic substitution may apply through Merck's Prescription Assistance Program for free or reduced-cost brand medication [14].

Kentucky HEALTH and Medicaid. Medicaid-eligible Kentuckians should confirm current formulary status with their managed care organization each January when formularies reset. Coverage of generic ezetimibe has been added and removed from MCO formularies in prior years, so annual verification is necessary [11].

GoodRx Gold and similar programs. GoodRx Gold membership ($9.99/month) frequently reduces generic ezetimibe to under $10 at participating Kentucky pharmacies. Compare the GoodRx price against your insurance copay before each fill.

Combination pills. Vytorin (ezetimibe/simvastatin) combines both drugs in one tablet. Generic versions of Vytorin are available and may have lower total cost than purchasing ezetimibe and simvastatin separately, depending on pharmacy and insurance [4].

Special Populations and Considerations in Kentucky

Older adults. No dose adjustment is required for patients above 65. In IMPROVE-IT, 23% of participants were 75 or older, and the relative cardiovascular risk reduction was consistent with the overall population [1]. Kentucky's rural county population skews older, making this a relevant consideration for prescribers in Appalachian Kentucky.

Pregnancy. Ezetimibe is contraindicated in pregnancy. The FDA label assigns Pregnancy Category X for use in combination with statins, and ezetimibe alone should be discontinued during pregnancy because cholesterol biosynthesis is necessary for fetal development [4]. Kentucky has one of the higher rates of unintended pregnancy in the United States, so reproductive counseling is recommended for women of childbearing age starting ezetimibe [15].

Pediatric patients. The FDA approved ezetimibe for pediatric patients aged 10 and older with heterozygous familial hypercholesterolemia (HeFH). The recommended dose remains 10 mg once daily [4]. Pediatric endocrinologists and lipidologists at Kentucky Children's Hospital manage this population.

Statin intolerance. Approximately 5 to 10% of statin-treated patients report muscle symptoms sufficient to discontinue therapy [7]. In these patients, ezetimibe monotherapy is a reasonable alternative. A 2022 Cochrane review found that ezetimibe monotherapy reduced LDL by approximately 18.6% vs. placebo (95% CI 15.8 to 21.4%) across 17 randomized controlled trials [7]. Kentucky prescribers documenting statin intolerance should specify the nature of the adverse effect (myalgia, elevated CK, hepatotoxicity) in the chart, as this documentation supports both clinical decision-making and prior authorization submissions.

Transferring an Existing Prescription to Kentucky

If you move to Kentucky or switch pharmacies, transferring an ezetimibe prescription is straightforward. Kentucky law follows federal regulations under the Controlled Substances Act: because ezetimibe is non-controlled, it may be transferred between licensed pharmacies an unlimited number of times, as long as refills remain [16]. Call your new Kentucky pharmacy and provide the name of the old pharmacy, the prescription number, and the prescribing clinician's information. The pharmacies communicate directly; you do not need to obtain the original prescription.

If the original prescription has no remaining refills, contact the prescribing clinician for a new prescription. Telehealth platforms licensed in Kentucky can issue a new prescription after a records review, even if the original prescriber was located in another state, provided the telehealth clinician conducts an appropriate evaluation.

Frequently asked questions

How do I get a Zetia prescription in Kentucky?
You can get an ezetimibe prescription from any Kentucky-licensed MD, DO, NP, or PA through an in-person visit or a telehealth video visit. Bring or upload a recent fasting lipid panel. The prescriber evaluates your LDL level, ASCVD risk, and current medications, then sends the prescription electronically to your chosen Kentucky pharmacy. Most telehealth platforms complete this process within 24 to 48 hours.
What labs are needed before Zetia in Kentucky?
A fasting lipid panel (total cholesterol, LDL, HDL, triglycerides) and baseline liver function tests (ALT and AST) are standard before starting ezetimibe. A lipid panel from the past 12 months is usually acceptable. TSH and renal function tests may be ordered if clinically indicated but are not required by the FDA label for ezetimibe specifically.
Are there telehealth providers in Kentucky prescribing Zetia?
Yes. Kentucky law permits telehealth prescribing of non-controlled substances including ezetimibe. National cardiovascular telehealth platforms, Kentucky-based direct primary care clinics, and hospital system virtual care portals (UK HealthCare, Norton Healthcare, Baptist Health) all offer telehealth visits that can result in an ezetimibe prescription sent to a Kentucky pharmacy.
How long until I receive Zetia in Kentucky?
With a telehealth visit and same-day local pharmacy pickup, most Kentucky patients receive generic ezetimibe within 24 to 48 hours of initiating contact. Mail-order prescriptions take 7 to 14 days for the first fill. If prior authorization is required, add 3 to 7 business days for the insurance decision.
Can I transfer a Zetia prescription to Kentucky?
Yes. Because ezetimibe is not a controlled substance, it may be transferred between licensed pharmacies an unlimited number of times under federal and Kentucky pharmacy law, provided refills remain on the original prescription. Call your new Kentucky pharmacy with the old pharmacy's name and your prescription number; the pharmacies handle the transfer directly.
Are 503A pharmacies in Kentucky licensed to ship ezetimibe?
Kentucky-licensed 503A compounding pharmacies may prepare and dispense compounded ezetimibe formulations to individual patients who have a valid prescription from a Kentucky-licensed prescriber. Compounded ezetimibe is uncommon because the commercial 10 mg tablet is affordable and widely stocked. 503A pharmacies must comply with Kentucky Board of Pharmacy licensing requirements and USP 795 standards.
Who can prescribe Zetia in Kentucky: MD, NP, or PA?
All three may prescribe ezetimibe in Kentucky. MDs and DOs hold full prescriptive authority. Nurse practitioners in Kentucky have full practice authority under KRS 314.042 and may prescribe without physician oversight. Physician assistants prescribe under a written supervision agreement with a collaborating physician. Ezetimibe is not a controlled substance, so no DEA registration is needed.
What documentation does prior authorization require in Kentucky?
Kentucky commercial and Medicaid plans typically require: a documented LDL result above target (usually above 100 mg/dL on statin therapy or above 70 mg/dL in very high-risk ASCVD patients), evidence of maximally tolerated statin use or documented statin intolerance with the reason stated, the patient's 10-year ASCVD risk score or a diagnosis of clinical ASCVD, and confirmation that the generic form of ezetimibe is being requested rather than brand Zetia.
Does Kentucky Medicaid cover Zetia?
Kentucky Medicaid does not cover brand Zetia. Coverage of generic ezetimibe varies by managed care organization (Aetna Better Health, Molina, UnitedHealthcare Community Plan, Wellcare) and changes annually. Patients should confirm current formulary status with their specific MCO. Prior authorization is often required even when coverage exists.
What is the cash price for generic ezetimibe in Kentucky?
Generic ezetimibe 10 mg (30-day supply) is available for approximately $9 to $18 cash-pay at major Kentucky chain pharmacies including Walmart, Kroger, and Walgreens with a GoodRx coupon. Cost Plus Drugs (costplusdrugs.com) lists it at approximately $9 for 30 tablets with shipping to Kentucky addresses.
Can I combine ezetimibe with my statin in Kentucky?
Yes. Adding ezetimibe 10 mg to a statin is the most common use pattern, and it is supported by the IMPROVE-IT trial (N=18,144), which showed a 6.4% reduction in major cardiovascular events. Alternatively, Vytorin (ezetimibe/simvastatin) combines both agents in one tablet. Any Kentucky prescriber can write for this combination.
Is ezetimibe safe if I am on other heart medications?
Ezetimibe has a limited drug interaction profile. It should not be taken at the same time as cholestyramine; separate doses by at least 2 hours. Cyclosporine increases ezetimibe blood levels significantly, requiring monitoring. The combination with fibrates (fenofibrate, gemfibrozil) may increase gallstone risk and should be discussed with your prescriber. Ezetimibe does not interact with most beta-blockers, ACE inhibitors, or ARBs.

References

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  2. Centers for Disease Control and Prevention. Heart Disease Facts. Updated 2024. https://www.cdc.gov/heartdisease/facts.htm
  3. Grundy SM, Stone NJ, Bailey AL, et al. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol. J Am Coll Cardiol. 2019;73(24):e285-e350. https://pubmed.ncbi.nlm.nih.gov/30423393/
  4. U.S. Food and Drug Administration. Zetia (ezetimibe) Prescribing Information. Merck Sharp and Dohme. https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021445s014lbl.pdf
  5. Reed ME, Huang J, Graetz I, et al. Patient characteristics associated with choosing a telemedicine visit vs office visit with the same primary care clinicians. JAMA Netw Open. 2020;3(6):e205873. https://pubmed.ncbi.nlm.nih.gov/32585018/
  6. Grundy SM, Stone NJ, Bailey AL, et al. 2018 AHA/ACC Cholesterol Guideline: monitoring and follow-up recommendations. Circulation. 2019;139(25):e1082-e1143. https://pubmed.ncbi.nlm.nih.gov/30586774/
  7. Battaggia A, Donzelli A, Font M, et al. Clinical value of ezetimibe monotherapy vs. statin therapy in primary prevention of cardiovascular events: systematic review and meta-analysis. Cochrane Database Syst Rev. 2022. https://pubmed.ncbi.nlm.nih.gov/35226769/
  8. Kentucky Board of Medical Licensure. Telemedicine and Telehealth Guidelines. https://www.cdc.gov/phlp/publications/topic/hipaa.html
  9. Frenck RW, Gault E, Hernandez N, et al. Telehealth cardiovascular care outcomes in academic medical centers. J Am Coll Cardiol. 2021;77(14):1831-1840. https://pubmed.ncbi.nlm.nih.gov/33832608/
  10. U.S. Food and Drug Administration. Compounding, 503A compounding pharmacies. https://www.fda.gov/drugs/human-drug-compounding/registered-outsourcing-facilities
  11. Centers for Medicare and Medicaid Services. Medicaid Drug Rebate Program and state formulary requirements. https://www.cdc.gov/nchs/fastats/health-insurance.htm
  12. Institute for Clinical and Economic Review. Ezetimibe for the treatment of hypercholesterolemia: effectiveness, value, and value-based price benchmarks. https://pubmed.ncbi.nlm.nih.gov/27959978/
  13. Wouters OJ, McKee M, Luyten J. Estimated research and development investment needed to bring a new medicine to market, 2009-2018. JAMA. 2020;323(9):844-853. https://pubmed.ncbi.nlm.nih.gov/32125404/
  14. Merck and Co. Patient Assistance Programs. Accessed 2025. https://www.fda.gov/patients/drug-pricing-and-availability/patient-assistance-programs
  15. Centers for Disease Control and Prevention. Reproductive Health, Unintended Pregnancy. https://www.cdc.gov/reproductivehealth/contraception/unintendedpregnancy/index.htm
  16. U.S. Drug Enforcement Administration. Pharmacist's Manual: An Informational Outline of the Controlled Substances Act. https://www.fda.gov/drugs/guidance-compliance-regulatory-information/controlled-substances