PROPOSED RULES
Notice Number: 2014-5
Rule Number: Ph 404 and Ph 405
1. Agency Name & Address:
Board of Pharmacy
121 South Fruit Street
Concord, New Hampshire 03301
2. RSA Authority: RSA 318:5-a, IT, IV-a, RSA 318:14-a, V
3. Federal Authority:
4. Type of Action:
Adoption _____
Amendment ______
Repeal ______
Readoption ______
Readoption w/amendment ___X___
5. Short Title: STANDARDS FOR COMPOUNDING AND DISPENSING STERILE PHARMACEUTICALS AND STANDARDS OF PRACTICE FOR NUCLEARIRADIOLOGIC PHARMACY
6. (a) Summary of what the rule says and the effect of the rule on those regulated:
Ph 404 rules provide definitions and specific requirements for all compounders engaged in compounding both sterile and non-sterile pharmaceuticals in a practice setting. The purpose of the rules is to assure that this integral practice of pharmacy is practiced in a safe environment; assuring the quality, sterility and potency of the finished product. This proposal differs from the former rules which expired on 3-26-13 in that the specification and details of sterile compounds are more precise and the licensee more accountable through inspection criteria.
Ph 405 rules regulate the practice of nuclear and radiologic pharmacy. These rules which expired 3-26-13 are being updated and the new rules do not differ from the expired rules.
6. (b) Brief description of the groups affected:
The affected groups include pharmacists, pharmacies (both in state and out of state) and practitioners that engage in the act of sterile and non-sterile compounding pharmaceuticals.
6. (c) Specific section or sections of state statute or federal statute or regulation which the rule is intended to implement:
|
RULE |
SECTION TITLE |
| Ph 404 |
RSA 318:5-a, II, IV-a, RSA 318:14-a |
| Ph 405 |
RSA 318:5-a, II, IV-a |
7. Contact person for copies and questions including requests to accommodate persons with disabilities:
Name: Jason Richard
Title: Interim Executive Secretary
Phone #: 603-271-2350
Fax #: 603-271-2856
E-Mail: pharmacy.board@nh.gov
TTY/TDD Access: Relay NH 1-800-735-2964 or dial 711 (in NH)
Address: 121 South Fruit St. Concord NH 03301
8. Deadline for submission of materials in writing or, if practicable for the agency, in the electronic format specified: February 19, 2014 at the end of the meeting.
_____x____Fax _____x____E-Mail _________Other format (specify)
9. Public hearing scheduled for:
Date and Time: February 19, 2014 9:00 AM - 12 noon
Place: Board of Pharmacy, 121 South Fruit Street, Concord, NH 03301
10. Fiscal Impact Statement (Prepared by Legislative Budget Assistant)
FIS # 13:248 dated: 1/9/14
1. Comparison of the costs of the proposed rule(s) to the existing rule(s):
The proposed -rules expired in March of 2013. The Board has continued to operate under the provisions of the expired rules. When compared to the expired rules, the proposed rules will increase costs to independently owned businesses by an indeterminable amount.
2. Cite the Federal mandate. Identify the impact on state funds:
No federal mandate, no impact on state funds.
3. Cost and benefits of the proposed rule(s):
A. To State general or State special funds:
None.B. To State citizens and political subdivisions:
None.C. To independently owned business:
Compliance with the proposed rules may increase costs to entities licensed to perform compounding of pharmaceuticals for training of personnel, evaluation of sterile products, and inspection and certification of equipment.
11. Statement Relative to Part I, Article 28-a of the N.H. Constitution:
These rules and the proposed amendments from the expired rules do not violate Part I, Article 28-a of the N.H. Constitution. This proposal is not an unfunded mandate to any political subdivision. The rules are in place to regulate the practice of compounding pharmacy in state and outside the state of New Hampshire, in the United States and do not apply to political subdivisions.