Researcher: JSB Page 1 3/23/21 OLR Bill Analysis sSB 694 AN ACT CONCERNING REVISIONS TO PHARMACY AND DRUG CONTROL STATUTES. SUMMARY This bill makes various unrelated changes to the laws concerning pharmacies and drugs, including: 1. allowing the Department of Consumer Protection (DCP) to immediately inactivate a practitioner’s controlled substance registration if his or her license, registration, or approval of a license to practice is inactive for more than 90 days (§ 1); 2. allowing pharmacists to prescribe an epinephrine auto injector (e.g., EpiPen) to someone who previously had a prescription for one, under certain circumstances (§ 2); 3. increasing from 10 to 45 days, the advance notice a compounding facility must give DCP when it plans to remodel or repair its sterile compounding facilities, and requiring emergency repairs to be reported within 24 hours (§ 3); and 4. expanding the requirement that pharmacists offer to consult with patients when dispensing medications to include controlled substances, in addition to other drug types, and applying the requirement to all pharmacies (§ 4). The bill also exempts from registering with DCP as a “drug wholesaler” (1) retail pharmacies that provide a limited quantity of drugs for emergency stock to a hospice inpatient facility’s medical director and (2) pharmacies within a hospital that contains another hospital wholly within its physical structure, if providing prescribed medications to be administered onsite to the contained hospital’s outpatients (§ 5). Existing law provides similar exemptions for 2021SB-00694-R000108-BA.DOCX Researcher: JSB Page 2 3/23/21 pharmacies (1) that provide emergency stock to nursing homes or (2) within a hospital that contains another hospital, when the drug will be used in the contained hospital’s inpatient unit. Lastly, the bill makes minor and technical changes. EFFECTIVE DATE: Upon passage, except the controlled substance registration provision is effective October 1, 2021 (§ 1) and the drug wholesaler definition provision is effective July 1, 2021 (§ 5). § 1 — CONTROLLED SUBSTANCE REGISTRATIONS The bill allows DCP to immediately inactivate a practitioner’s controlled substance registration if his or her license to practice, or related registration or approval, is inactive for more than 90 days. Current law requires DCP to notify the practitioner and hold an administrative hearing prior to taking such action. The bill specifies that an inactivation is not a disciplinary action and that the controlled substance registration must be reinstated without charge if the practitioner restores his or her license, registration, or approval to practice with the Department of Public Health or the associated board or commission before the registration was set to expire. By law, a practitioner who prescribes, distributes, administers, or dispenses a controlled substance must obtain a registration from DCP. Practitioners eligible for the registration include physicians, dentists, veterinarians, advanced practice registered nurses, and scientific investigators, among others. § 2 — EPINEPHRINE AUTO INJECTOR PRESCRIPTIONS The bill permits a pharmacist, in his or her professional discretion, to issue a prescription for up to two epinephrine auto injectors if the pharmacist: 1. confirms another pharmacy has dispensed the medication to the patient under a prescription within the past two years; 2021SB-00694-R000108-BA.DOCX Researcher: JSB Page 3 3/23/21 2. identifies the patient's primary care provider, based on information the patient provides when requesting the prescription; 3. informs the patient's primary care provider within seventy-two hours after issuing the prescription (by phone, fax, or electronic transmission); and 4. does not prescribe refills or fill the prescription more than once per year. The bill defines "epinephrine auto injector" as a prefilled auto injector or similar automatic injectable equipment used to deliver epinephrine in a standard dose for emergency first aid response to allergic reactions. The bill specifies that it does not prevent a pharmacist from verifying a previous prescription at any other U.S. pharmacy, including pharmacies in any area under U.S. jurisdiction (e.g., a territory). § 3 — STERILE COMPOUNDING FACILITY CHANGES The bill increases, from 10 to 45 days, the advance notice a compounding facility must give DCP before it begins to remodel, relocate, upgrade, or repair sterile compounding areas or adjacent spaces, including: 1. remodeling an area used for compounding sterile pharmaceuticals or an adjacent space; 2. relocating the sterile compounding area; or 3. in a sterile compounding area, upgrading or conducting a nonemergency repair to the heating, ventilation, air conditioning, or primary or secondary engineering controls. The bill also requires emergency repairs made in these pharmacies to be reported within 24 hours after they started, instead of as soon as possible as under current law. 2021SB-00694-R000108-BA.DOCX Researcher: JSB Page 4 3/23/21 Additionally, the bill makes related minor changes, including requiring notice when secondary engineering controls are upgraded or repaired. § 4 — PHARMACIST CONSULTAT IONS The bill requires pharmacists or pharmacy employees, before or while dispensing a controlled substance, to offer for the pharmacist to counsel a patient on the drug and its use. Current law already requires pharmacists and employees to do this for other dispensed drug types. As under current law, the requirement does not apply if the (1) person picking up the prescription is not the patient or (2) pharmacist determines it is appropriate to make the offer in writing. A written offer must give the patient the option to communicate in person at the pharmacy or by telephone. The bill specifies that the consultation requirement applies to all pharmacies instead of only (1) hospital pharmacies, when dispensing a drug for outpatient use or use by an employee or the employee’s spouse or children, and (2) state-licensed pharmacies. As under current law, pharmacists are not required to provide counseling if a patient refuses it. COMMITTEE ACTION General Law Committee Joint Favorable Substitute Yea 19 Nay 0 (03/09/2021)