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 2024-29, July 17, 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