nh-2026-210: Licensing and Standards of Practice for Manufacturers, Wholesalers, and Distributors

1. Agency: Pharmacy Board

Agency Address: Pharmacy Board c/o Office of Professional Licensure and Certification 7 Eagle Square Concord, NH

6. (a) Summary of what the rule says and of any proposed amendments including

whether the rule implements a state statute for the first time: The NH Pharmacy Board (Board) is proposing to readopt with amendment Ph 1001 and Ph 1002 on the licensing and operations standards of practice for manufacturers, wholesalers, and distributors. Amendments to Ph 1001 are proposed to incorporate changes made by the legislature to the office of professional licensure and certification (OPLC) statutes in 2023, 235:8, effective July 15, 2023, to include applications and fees. Ph 1002.05 regarding inspections is marked for repeal. RSA 318:9-a, effective September 1, 2023, grants OPLC the authority to provide inspection services (2023, 79:307). Ph 1002.01 through Ph 1002.04 are proposed to be readopted without change. Ph 1002.06 through Ph 1002.10 are renumbered. Ph 1002.12 through Ph 1002.15 are marked for repeal. The Board’s former rulemaking authority for fees in RSA 318:-6-a was repealed effective September 1, 2023 (2023, 79:318, II). All the sections in this proposal besides Ph 1001.01 and Ph 1002.12 are set to expire October 16, 2026, but are subject to extension under RSA 541-A:14-a. ADMINISTRATIVE RULES (603) 271-3680 Generated on 10/01/2026 X Does this rule implement a state statute for the first time? If yes, please explain: Amendments to Ph 1001 are proposed to incorporate changes made by the legislature to the office of professional licensure and certification (OPLC) statutes in 2023, 235:8, effective July 15, 2023, to include applications and fees. The Board’s former rulemaking authority for fees in RSA 318:-6-a was repealed effective September 1, 2023 (2023, 79:318, II). Ph 1002.05 regarding inspections is marked for repeal. RSA 318:9-a, effective September 1, 2023, grants OPLC the authority to provide inspection services (2023, 79:307). 6. (b) Brief description of the groups affected: Individuals seeking an initial license, or to renew an existing license as a manufacturer, wholesaler or distributor are affected by the proposed rules. 6. (c) Specific section or sections of state statute or federal statute or regulation which the rule is intended to implement: Rule Specific State Statute the Rule Implements Ph 1001.01 RSA 318:51-a, I Ph 1001.02 (repealed) Ph 1001.03 (repealed) Ph 1002.01 RSA 318:5-a, IV-a, VI, and IX; RSA 318:8-a; RSA 318:51-a Ph 1002.02 RSA 318:5-a, IV-a, VI, and IX; RSA 318:8-a; RSA 318:51-a Ph 1002.03 RSA 318:5-a, IV-a, VI, and IX; RSA 318:8-a; RSA 318:51-a Ph 1002.04 RSA 318:5-a, IV-a, VI, and IX; RSA 318:8-a; RSA 318:51-a Ph 1002.05 (repealed) Ph 1002.05 (formerly Ph RSA 318:5-a, IV-a, VI, and IX; RSA 318:8-a; RSA 1002.06) 318:51-a Ph 1002.06 (formerly Ph RSA 318:5-a, IV-a, VI, and IX; RSA 318:8-a; RSA 1002.07) 318:51-a Ph 1002.07 (formerly Ph RSA 318:5-a, IV-a, VI, and IX; RSA 318:8-a; RSA 1002.08) 318:51-a Ph 1002.08 (formerly Ph RSA 318:5-a, IV-a, VI, and IX; RSA 318:8-a; RSA 1002.09) 318:51-a Ph 1002.09 (formerly Ph RSA 318:5-a, IV-a, VI, and IX; RSA 318:8-a; RSA 1002.10) 318:51-a Ph 1002.11 (repealed) Ph 1002.12 (repealed) ADMINISTRATIVE RULES (603) 271-3680 Generated on 10/01/2026 Ph 1002.13 (repealed) Ph 1002.14 (repealed) Ph 1002.15 (repealed)

7. Contact person for copies and questions including requests to accommodate

persons with disabilities: Name: Chantell Wheeler Title: Rules Administrator Address: Office of Professional Licensure and Certification 7 Eagle Phone Number: (603) 271-8311 Square Concord, NH FAX Number: Email: chantell.b.wheeler@oplc.nh.gov

8. Deadline for submission of materials in writing or, if practicable for the agency, in

the electronic format specified: Wednesday, November 25, 2026 _ Fax X Email OPLC-Rules@oplc.nh.gov _ Other

9. Public hearing scheduled for:

Date: Wednesday, November 18, 2026 Time: 9:10 AM Place: Office of Professional Licensure and Certification 7 Eagle Square Concord, NH Electronic Access, if applicable: N/A

10. Fiscal Impact Statement (Prepared by Legislative Budget Assistant):

FIS #: 26:221, dated: Monday, September 28, 2026

1. Comparison of the costs of the proposed rule(s) to the existing rule(s):

There is no difference in costs when comparing the proposed rules to the existing rules.

2. Cite the Federal mandate. Identify the impact on state funds:

No Federal mandate, no impact on state funds. ADMINISTRATIVE RULES (603) 271-3680 Generated on 10/01/2026

3. Cost and benefits of the proposed rule(s):

There is no cost with the proposed repeal of the fee referenced in Ph 1001.01(d), relative to the original and biennial renewal licenses for manufacturers and wholesale distributors as that fee is applicable to Plc 1002.38, relative to application processing and licensing fees for the facilities and professions regulated by the N.H. Pharmacy Board. Additionally, there is no cost with the proposed repeal of the $150 fine in Ph 1002.12(b) as fines are applicable to Plc 311 rules as well as the late reinstatement fee referenced in the repeal of Ph 1002.12(c) which is applicable to Plc 1002.38.

C. To independently owned businesses:

None. 11. Statement Relative to Part I, Article 28-a of the N.H. Constitution: The rules do not apply to political subdivisions. The rules do not mandate or assign any new, expanded, or modified programs or responsibilities to any political subdivision in such a way as to necessitate additional local expenditures and therefore do not violate Part I, Article 28-a of the N.H. Constitution. ADMINISTRATIVE RULES (603) 271-3680 Generated on 10/01/2026