Code of Maine Rules
02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION
392 - MAINE BOARD OF PHARMACY
Part 5 - LICENSE DENIAL AND PROFESSIONAL DISCIPLINE
Chapter 29 - VIOLATIONS OF STATE OR FEDERAL LAW OR RULE; OTHER STANDARDS
Section 392-5-29-1 - Violations of Federal Law or Rule as Constituting Unprofessional Conduct
Current through 2024-38, September 18, 2024
The board finds that the federal legislative and regulatory scheme contained in the laws and rules listed in this section have established standards of professional behavior in the practice of pharmacy and the operation of drug outlets licensed or registered by the board. Unprofessional conduct includes, but is not limited to, any violation of the following laws and rules as they relate to prescription drugs and controlled substances:
1. Federal Food, Drug and Cosmetics Act, 21 USCS §301 et seq. ( current through PL 112-263, with a gap of 112-239, approved 1/14/13, www.lexis.com [File Link Not Available])
2. Drug Abuse Prevention and Control law, 21 USCS §801 et seq., including but not limited to the Controlled Substances Act (current through PL 112-263, with a gap of 112-239, approved 1/14/13, www.lexis.com)
3. Fair Packaging and Labeling Act, 15 USCS §1451 et seq. ( current through PL 112-263, with a gap of 112-239, approved 1/14/13, www.lexis.com)
4. Poison Prevention Packaging Act, 15 USCS §1471 et seq. ( current through PL 112-263, with a gap of 112-239, approved 1/14/13, www.lexis.com)
5. The following FDA rules, codified in 21 CFR (April 1, 2012)-
| Part 200 | General |
| Part 201 | Labeling |
| Part 202 | Prescription Drug Advertising |
| Part 203 | Prescription Drug Marketing |
| Part 205 | Guidelines for State Licensing of Wholesale Prescription Drug Distributors |
| Part 206 | Imprinting of Solid Oral Dosage Form Drug Products for Human Use |
| Part 207 | Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution |
| Part 208 | Medication Guides for Prescription Drug Products |
| Part 209 | Requirement for Authorized Dispensers and Pharmacies to Distribute a Side Effects Statement |
| Part 210* | Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General |
| Part 211* | Current Good Manufacturing Practice for Finished Pharmaceuticals |
| Part 212 | Current Good Manufacturing Practice for Positron Emission Tomography Drugs |
| Part 216 | Pharmacy Compounding |
| Part 226 | Current Good Manufacturing Practice for Type A Medicated Articles |
| Part 250 | Special Requirements for Specific Human Drugs |
| Part 290 | Controlled Drugs |
| Part 299 | Drugs; Official Names and Established Names |
*Does not apply to the compounding of sterile or non-sterile drugs by retail pharmacies pursuant to 32 MRSA §13702-A(4) and Chapter 13, Section 7 and Chapter 37 of the board's rules.
6. The following DEA rules, codified in 21 CFR (April 1, 2012)-
| Part 1300 | Definitions |
| Part 1301 | Registration of Manufacturers, Distributors, and Dispensers of Controlled Substances |
| Part 1302 | Labeling and Packaging Requirements for Controlled Substances |
| Part 1304 | Records and Reports of Registrants |
| Part 1305 | Order Forms |
| Part 1306 | Prescriptions |
| Part 1307 | Miscellaneous |
| Part 1308 | Schedules of Controlled Substances |
| Part 1309 | Registration of Manufacturers, Distributors, Importers and Exporters of List I Chemicals |
| Part 1310 | Records and Reports of Listed Chemicals and Certain Machines |
| Part 1311 | Requirements for Electronic Orders and Prescriptions |
| Part 1312 | Importation and Exportation of Controlled Substances |
| Part 1313 | Importation and Exportation of Precursors and Essential Chemicals |
| Part 1314 | Retail Sale of Scheduled Listed Products |
7. The following rules of the Federal Trade Commission, codified in 16 CFR (January 1, 2013)-
| Parts 500-503 | Rules, Regulations, Statement of General Policy or Interpretation and Exemptions Under the Fair Packaging and Labeling Act |
8. The following rules of the Consumer Product Safety Commission, codified in 16 CFR (January 1, 2013)-
| Parts 1700-1702 | Poison Prevention Packaging Act of 1970 Regulations |
9. The following law and rules relating to the federal/state Medicaid program (MaineCare), state nursing home licensure, and the state Medicaid plan-
| 42 USCS §1396r-8(g) | Grants to States for Medical Assistance Programs (drug use review) (current through PL 112-263, with a gap of 112-239, approved 1/14/13, www.lexis.com) |
| 42 CFR Part 456 | Utilization Control (Centers for Medicare & Medicaid Services, Dept. of Health and Human Services, October 1, 2012) |
| 10-144 Chapter 101, Chapter II, Section 80 | MaineCare Benefits Manual - Pharmacy Services (Bureau of Medical Services, Dept. of Human Services, January 1, 2013) |
| Pp. 74a-74c | State Medicaid Plan (State Plan Under Title XIX of the Social Security Act (pp. 74a-74c approved May 24, 1993) |
| Ch. 110, Ch. 17 | Regulations Governing the Licensing and Functioning of Skilled Nursing Facilities and Nursing Facilities / Pharmaceutical Services (DHHS, February 1, 2001 edition, as amended effective October 15, 2004) |
10. The following reference standards of the U.S. Pharmacopeia-
| USP <795> | United States Pharmacopeia USP 36-NF 31, General Chapter <795>, Pharmaceutical Compounding - Nonsterile Preparations, 2013-14 edition, Vol. 1, p. 355 |
| USP <797> | United States Pharmacopeia USP 36-NF 31, General Chapter <797>, Pharmaceutical Compounding - Sterile Preparations, 2013-14 edition, Vol. 1, p. 361 |
