1. 2016 New Laws Update

2. Greg Reybold, J.D. VP Public Policy & Association Counsel Georgia Pharmacy Association

3. Disclosure I do not have (nor does any immediate family member have) actual or potential conflict of interest, within the last twelve months; a vested interest in or affiliation with any corporate organization offering financial support or grant monies for this continuing education activity; or any affiliation with an organization whose philosophy could potentially bias my presentation. Attending this presentation, or using the information it contains does not create an attorney-client relationship. No information provided should be construed to constitute legal advice. If you have questions about these or other legal issues please contact an attorney.

4. PDMP – HB900  Takes effect July 1, 2016  Collaboration between GPhA, MAG, and GDNA  Targeted revisions designed to increase use and effectiveness  Delegation  Delegation of retrieval & review to identify misuse/abuse/underutilization

5. PDMP – HB900 continued…  Any person “licensed, registered or certified” by BOP or MCB  Pharmacists _ technicians  Physicians - PAs  Does not contemplate delegation of inputting information  O.C.G.A. 16-13-60(c)

6. PDMP – HB900 continued… Communication: An individual authorized to access electronic data base prescription information pursuant to this part may: (1)Communicate concerns about a patient’s potential misuse, abuse, or underutilization of a controlled substance with other prescribers and dispensers that are involved in the patient’s health care (2)Report potential violations of this article to the agency for review or investigation. O.C.G.A. 16-13-60(c.1)

7. State Meth Registry [HB 362 – previously HB 588] How sold  Nonprescription products whose sole active ingredient is ephedrine or pseudoephedrine shall only be sold in a pharmacy in a manner which complies with State Board of Pharmacy rules established pursuant to Code Section 16-13-29.2. O.C.G.A. 16-13-30.3(c)(1).

8. State Meth Registry [HB 362 – previously HB 588] cont… Quantity Limits No person shall distribute or purchase any nonprescription product containing more than 3.6 grams of ephedrine or pseudoephedrine per day in dosage form or more than 9 grams of ephedrine or pseudoephedrine per 30 day period in dosage form of any product. The limits set forth in this paragraph shall apply to the total amount of ephedrine or pseudoephedrine contained in the product and not the overall weight of such product. O.C.G.A. 16-13-30.3(c)(2).

9. State Meth Registry [HB 362 – previously HB 588] cont… Records Maintain record for two year period from date of each transaction. O.C.G.A. 16-13-30.3(c)(3).

10. State Meth Registry [HB 362 – previously HB 588] cont… Logging System Pharmacies shall, before completing a sale of a nonprescription product which contains ephedrine or pseudoephedrine, electronically track all such sales and submit the required information to a real-time electronic logging system. A pharmacy shall not complete the sale of a nonprescription product which contains ephedrine or pseudoephedrine if the real-time electronic logging system generates a stop sale alert except as provided in subparagraph (a)(4)(A) of this Code section. O.C.G.A. 16-13-30.3(c)(4)(A). Override – Reasonable fear of imminent bodily harm.

11. Drug Law Update (HB 926)  Amended provisions relating to the compounding of drug products to conform with federal law  Bill does a lot with a particular emphasis on logistics  We will unpack the provisions most impacting pharmacy directly

12. Drug Law Update (HB 926)  Expands temporary licenses (O.C.G.A. § 26-4-43).  Temporary licenses shall expire at the end of the month following the third board meeting conducted after the issuance of such license and may not be reissued or renewed  For service members for a period of six months

13. Drug Law Update (HB 926)  Compounding (O.C.G.A. § 26-4-86(b))  All drug products compounded by a licensed outsourcing facility shall also be compounded in accordance with applicable current good manufacturing practices  In regards to pharmacists compounding nonpatient specific sterile drugs to be provided to practitioners to use in patient care or altering or repackaging such drugs for practitioners to use in patient care in the practitioner’s office, such nonpatient specific sterile compounding shall only be conducted by an outsourcing facility and as allowed by applicable federal law and board rule for pharmaceutical compounding using USP-NF standards for sterile compounding.

14. Uniform Emergency Voluteers Health Practioners Act (SB230)  Pharmacists are impacted by this bill  Health practitioner means an individual licensed under the laws of this or another state to provide health services or veterinary services.  Health services means the provision of treatment, care, advice, or guidance, or other services or supplies, related to the health or death of individuals or human populations to the extent necessary to respond to an emergency, including…[t]he sale or dispensing of a drug, a device, equipment, or another item to an individual in accordance with a prescription.

15. Uniform Emergency Voluteers Health Practioners Act (SB230) – Legal liability protection, governor may mobilize Key Terms  ‘Volunteer health practitioner’ means a health practitioner who provides health services or veterinary services pursuant to this article at no charge to the patients receiving such services, so long as such health practitioner does not receive compensation in direct relation to those specific services. OCGA 38-3-161  Host entity means an entity operating in this state which uses volunteer health practitioners to respond to an emergency. OCGA 38-3-161

16. Uniform Emergency Voluteers Health Practioners Act (SB230) – Legal liability protection, governor may mobilize Continued…  This article shall only apply to volunteer health practitioners registered with a registration system that complies with Code Section 38-3-164 and who provide health services or veterinary services in this state for a host entity while an emergency declaration is in effect. OCGA 38-3-162

17. Uniform Emergency Voluteers Health Practioners Act (SB230) – Legal liability protection, governor may mobilize What it does  When Emergency Declaration is in effect, Governor has ability to limit, restrict, and regulate duration of practice, geographical areas in which volunteer health practitioners may practice, types of practitioners who may practice, other matters necessary to coordinate provision of health care services  Regulates host entities – must coordinate with Georgia Emergency Management Agency

18. Uniform Emergency Voluteers Health Practioners Act (SB230) – Legal liability protection, governor may mobilize What it does continued…  Sets forth requirements for health practitioner registration system  Addresses scope of practice  Provides for legal liability protections for negligence

19. Drug Repository for Unused Meds for Indigent and Elderly (HB897) – Allows pharmacies to be drop-offs and re-dispense  Requires DPH to establish drug repository program by January 2017  Pharmacies are eligible recipients under the program  Participation not mandatory  No controlled substances

20. Drug Repository for Unused Meds for Indigent and Elderly (HB897) – Allows pharmacies to be drop-offs and re-dispense continued… Drugs shall only be dispensed pursuant to the program if: (1) For prescription drugs, they do not expire before the completion of the medication by the eligible patient based on the prescribing health care professional’s directions for use and, for over-the- counter drugs, they do not expire before use by the eligible patient based on the directions for use on the manufacturer’s label; and

21. Drug Repository for Unused Meds for Indigent and Elderly (HB897) – Allows pharmacies to be drop-offs and re-dispense continued… Drugs shall only be dispensed pursuant to the program if: (2) The drugs were donated in unopened tamper- evident packaging as defined by United States Pharmacopeia General Chapter 659, Packaging and Storage Requirements including but not limited to unopened unit-dose and multiple-dose packaging. O.C.G.A. § 31-8-302.

22. Immunizations (HB 1043)  Protocol agreements no longer must require “complete case history” but rather, to “appropriate case history.” O.C.G.A 43-34-26.1(d)(3)  Applies to all pharmacists operating under a protocol  Be aware that unless you update your protocol, you are still bound to “complete case history.”

23. Immunizations (HB 1043) within  Activities conducted within hospitals, physician offices, nursing homes, health care facilities already exempted from protocol requirements  This Bill carves out certain exemptions for activities conducted by hospitals or health systems whether on premises or not for patients as long as certain conditions are met including consent form and notation in patient’s health record.

24. Immunizations (HB 1043) Exempt from O.C.G.A. 43-34-26. 1(d)(5)-(9)(15)&(16)  Providing materials from DPH  Providing personal immunization card  Documentation retention requirements  Posting protocol agreement  Notarized affidavit O.C.G.A. 43-34-26.1(o)(2)

25. Mail Order (HB 886)  Revision to O.C.G.A. 26-4-60(11)  Board and GDNA did a wonderful job narrowing bill to protect Board’s power to regulate mail order  With regard to shipping methods only, must utilize method as appropriate and in accordance with standards of manufacturer, United States Pharmacopia, and FDA.

26. Mail Order (HB 886)  Requirement to also comply with “other standards adopted by Board of Pharmacy” removed.  Statement added making clear that except for the foregoing, compliance with Board of Pharmacy rules and regulations for delivery by mail required.

27. Provider Directories (SB 302)  New code section O.C.G.A. 33-20C-1 et. seq.  Requires Health Insurers to maintain accurate provider directories on line and in print  Applies to pharmacists  Update on-line every 30 days  Does not apply to DCH contracts

28. HV 965 (Jimmy Carter Cancer Treatment Access Act)  New code section O.C.G.A. § 33-24-59.2  Deals with stage four metastatic cancer  Prohibits health benefit plans from limiting or excluding coverage for a drug approved by the FDA by mandating the insured first be required to fail to successfully respond to a difficult drug or drugs

29. Governor Oversight of Professional Boards (HB952)  New code section O.C.G.A. § 43-1C-1 et. seq.  Bill cites N.C. State Bd. Of Dental Exam’rs v. FTC, 135 S. Ct. 1101 (2015) which held to invoke immunity state board actions must be consistent with “clearly articulated” state policy  Bill aims to provide anti-trust immunity to members of regulatory boards and commissions by giving Governor or his designee oversight

30. Questions/Comments

31. Greg Reybold, J.D. greybold@gpha.org Visit GPhAconvention.com/grow to download materials from this and other presentations.